| 1 |
NCT03087656 |
Recruiting |
Antibiotics to Decrease Post ERCP Cholangitis |
|
- Drug: Ceftriaxone
- Drug: Levofloxacin
|
Interventional |
Phase 4 |
- University of Southern California
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion.
- Days of hospitalization
- Proportion of patients who develop adverse events of antibiotics
|
200 |
All |
19 Years to 90 Years (Adult, Senior) |
NCT03087656 |
HS-16-00880 |
|
March 29, 2017 |
February 23, 2019 |
February 23, 2019 |
March 22, 2017 |
April 20, 2017 |
|
- Los Angeles County Hospital
Los Angeles, California, United States
|
| 2 |
NCT02601417 |
Recruiting |
The Necessity of Bile Cultures in Patients With Acute Cholangitis |
|
- Other: Ignoring result of bile culture
|
Interventional |
Not Applicable |
- Seoul National University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Organ Failure
- Hospital days
- Re-intervention for biliary drainage
- Mortality
|
440 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT02601417 |
2015-1452 |
|
August 27, 2015 |
August 2018 |
February 2019 |
November 10, 2015 |
September 8, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
| 3 |
NCT02712736 |
Recruiting |
Quality of Life in Patients With Primary Sclerosing Cholangitis |
- Primary Sclerosing Cholangitis
|
- Other: quality of life survey
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Impaired quality of life as measured by questionnaire
|
250 |
All |
18 Years and older (Adult, Senior) |
NCT02712736 |
Pro00069683 |
QOL in PSC |
July 1, 2016 |
June 30, 2018 |
June 30, 2018 |
March 18, 2016 |
March 2, 2018 |
|
- Duke University
Durham, North Carolina, United States
|
| 4 |
NCT03146936 |
Recruiting |
Swiss Primary Sclerosing Cholangitis Cohort Study |
|
|
Observational |
|
- Fondazione Epatocentro Ticino
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Disease course
- Disease features
- Response to treatment
- (and 2 more...)
|
120 |
All |
Child, Adult, Senior |
NCT03146936 |
SASL40 - Swiss PSC Cohort |
|
February 28, 2017 |
December 31, 2022 |
December 31, 2022 |
May 10, 2017 |
May 17, 2017 |
|
- Fondazione Epatocentro Ticino
Lugano, Ticino, Switzerland - Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung
Basel, Switzerland - Inselspital
Bern, Switzerland - (and 10 more...)
|
| 5 |
NCT03394924 |
Recruiting |
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis |
- Primary Biliary Cholangitis
|
- Drug: EDP-305 Dose 1
- Drug: EDP-305 Dose 2
- Drug: Placebo
|
Interventional |
Phase 2 |
- Enanta Pharmaceuticals
- Pharmaceutical Research Associates
- Triangle Biostatistics
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12
- Safety as measured by • Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12
- Change from baseline in Bilirubin
- (and 20 more...)
|
119 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03394924 |
EDP 305-201 |
|
December 27, 2017 |
March 2019 |
April 2019 |
January 9, 2018 |
March 21, 2018 |
|
- Inland Empire Liver Foundation
Rialto, California, United States - American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
|
| 6 |
NCT03359174 |
Recruiting |
An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis |
|
- Drug: All-trans retinoic acid
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent change of serum alkaline phosphatase (ALP)
- The percent of patients who have normalization of serum ALP or reduction to less than 1.5 x upper limit of normal (ULN)
- The percent of patients who have reduction of serum C4 by 50%
- (and 4 more...)
|
20 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03359174 |
2000021447 |
|
March 2018 |
December 1, 2020 |
January 1, 2021 |
December 2, 2017 |
February 19, 2018 |
|
- Yale University
New Haven, Connecticut, United States
|
| 7 |
NCT03394781 |
Recruiting |
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC) |
- Primary Sclerosing Cholangitis
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Percent change of ALP from baseline
- Percent change of liver enzymes
- Percent change of selected biomarkers
|
40 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03394781 |
C928-008 |
|
January 22, 2018 |
January 2019 |
January 2019 |
January 9, 2018 |
April 19, 2018 |
|
- Stanford University
Palo Alto, California, United States - California Pacific Medical Center
San Francisco, California, United States - University of Colorado
Aurora, Colorado, United States - (and 6 more...)
|
| 8 |
NCT02239211 |
Recruiting |
A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis |
- Primary Sclerosing Cholangitis
|
|
Interventional |
Phase 2 |
- University of Birmingham
- Biotie Therapies Corp.
- University Hospital Birmingham
- National Institute for Health Research, United Kingdom
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the activity of the anti-Vap-1 antibody BTT1023 in patients with PSC as measured by a decrease in alkaline phosphatase levels (primary endpoint) with secondary endpoints to include various measures of liver injury and fibrosis.
- To evaluate the safety and tolerability of BTT1023 in patients with PSC
- To determine the mechanisms of action of BTT1023 through in vivo assessment of SSAO enzyme activity and immune cell function.
- (and 2 more...)
|
41 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02239211 |
RG_13-027
2014-002393-37 |
BUTEO |
September 8, 2015 |
January 2019 |
March 2019 |
September 12, 2014 |
June 14, 2017 |
|
- Queens Medical Centre
Nottingham, Nottinghamshire, United Kingdom - University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom - Royal Victoria Infirmary
Newcastle, United Kingdom - John Radcliffe
Oxford, United Kingdom
|
| 9 |
NCT02780752 |
Not yet recruiting |
A Study of Oral Hymecromone to Treat Adults With Primary Sclerosing Cholangitis |
- Primary Sclerosing Cholangitis
|
|
Interventional |
Phase 1
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Number of participants with a qualitative improvement in the anatomy of the biliary tree as assessed by Magnetic Resonance Cholangiopancreatography
- Hyaluronan serum levels
- (and 3 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT02780752 |
37758 |
|
October 2018 |
September 2020 |
September 2020 |
May 23, 2016 |
February 8, 2018 |
|
- Stanford University
Palo Alto, California, United States
|
| 10 |
NCT02978339 |
Recruiting |
A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis |
- Primary Sclerosing Cholangitis
|
|
Interventional |
Phase 1
Phase 2 |
- John E. Eaton
- EuroPharma, Inc.
- Mayo Clinic
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of Subjects Who Experience a 40% Reduction in Serum Alkaline Phosphatase (ALP)
- Proportion of Subjects Who Experience a Decrease in Serum ALP to Less than 1.5 times the Upper Level of Normal
- Mean Change in Serum Aspartate Aminotransferase (AST)
- (and 7 more...)
|
15 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02978339 |
14-002660 |
|
June 9, 2017 |
June 2018 |
June 2018 |
November 30, 2016 |
December 26, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
| 11 |
NCT03124108 |
Recruiting |
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid |
- Primary Biliary Cholangitis (PBC)
|
- Drug: Elafibranor 80 mg
- Drug: Elafibranor 120 mg
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in serum alkaline phosphatase (ALP)
- Composite endpoint composed of ALP and total bilirubin
- Paris I PBC risk score
- (and 12 more...)
|
45 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03124108 |
GFT505B-216-1
2016-003817-80 |
|
April 5, 2017 |
April 2018 |
April 2018 |
April 21, 2017 |
February 21, 2018 |
|
- Mayo Clinic in Arizona
Phoenix, Arizona, United States - Schiff Center for Liver Diseases
Miami, Florida, United States - Massachusetts General Hospital
Boston, Massachusetts, United States - (and 17 more...)
|
| 12 |
NCT03345589 |
Not yet recruiting |
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis |
- Primary Biliary Cholangitis
|
- Drug: 18-22mg/kg/d Ursodeoxycholic
- Drug: 13-15mg/kg/d Ursodeoxycholic
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)
- Alkaline phosphatase
- Glutamyltransferase
- (and 3 more...)
|
40 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03345589 |
PBC-3 |
|
January 30, 2018 |
December 1, 2018 |
January 1, 2019 |
November 17, 2017 |
January 9, 2018 |
|
|
| 13 |
NCT03155932 |
Recruiting |
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Patients With Primary Biliary Cholangitis |
- Primary Biliary Cholangitis
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline to Week 24 in serum ALP concentration.
- Number of patients with adverse events and abnormal clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis).
- Change from baseline to Week 12 in serum ALP concentration.
- (and 14 more...)
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03155932 |
APD334-010 |
|
December 15, 2017 |
December 2018 |
December 2018 |
May 16, 2017 |
April 19, 2018 |
|
- Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia - Sunshine Coast University Hospital
Birtinya, Queensland, Australia - Alfred Health
Melbourne, Victoria, Australia - (and 2 more...)
|
| 14 |
NCT01688024 |
Recruiting |
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis |
- Primary Sclerosing Cholangitis
|
- Drug: Mitomycin C
- Drug: Normal saline
|
Interventional |
Phase 2 |
- Li, Zhiping, M.D.
- Johns Hopkins University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
- Number of Patients with Adverse Events
- Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
|
130 |
All |
18 Years and older (Adult, Senior) |
NCT01688024 |
NA_00052685 |
|
September 2012 |
September 2017 |
September 2019 |
September 19, 2012 |
September 7, 2016 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
| 15 |
NCT03092765 |
Recruiting |
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid |
- Primary Biliary Cholangitis
|
|
Interventional |
Phase 2 |
- EA Pharma Co., Ltd.
- Eisai Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Rate of change from Baseline in serum alkaline phosphatase (ALP) values at Week 12
- Number of participants with a decrease in ALP response rates of 15%, 20%, and 40% from Baseline
- Number of participants with an ALP value less than 1.67 times the upper limit normal and a total bilirubin value within normal limits and a greater than or equal to 15% decrease in ALP from Baseline
- (and 24 more...)
|
80 |
All |
20 Years to 74 Years (Adult, Senior) |
NCT03092765 |
E6011/ET1 |
|
March 23, 2017 |
February 2020 |
March 2020 |
March 28, 2017 |
October 24, 2017 |
|
- EA Pharma trial site
Toon, Ehime, Japan - EA Pharma trial site
Yoshida, Fukui, Japan - EA Pharma trial site #1
Fukuoka-shi, Fukuoka, Japan - (and 17 more...)
|
| 16 |
NCT03322943 |
Recruiting |
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital |
- Primary Biliary Cholangitis
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Description of demographics, clinical index after treatment
- Evaluation whether the PBC patients have response after treatment
|
300 |
All |
25 Years to 85 Years (Adult, Senior) |
NCT03322943 |
PBC-2 |
|
January 1, 2016 |
September 1, 2018 |
December 1, 2018 |
October 26, 2017 |
October 26, 2017 |
|
- West China Hospital
Chengdu, Sichuan, China
|
| 17 |
NCT03188146 |
Recruiting |
Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid |
- Primary Biliary Cholangitis (PBC)
|
- Drug: Ursodeoxycholic Acid
|
Observational |
|
- Humanity and Health Research Centre
- Beijing 302 Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Liver related Death
- Complications of cirrhosis
- Liver transplant
|
500 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03188146 |
H&H_PBC_01 |
|
May 1, 2017 |
May 1, 2027 |
May 1, 2028 |
June 15, 2017 |
June 15, 2017 |
|
- Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.
Beijing, China
|
| 18 |
NCT02543957 |
Recruiting |
Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy |
|
- Procedure: Cholangioscopy
|
Observational |
|
- Baylor College of Medicine
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Examine the Incidence of new onset infectious complications
- Examine the incidence of bacteremia in patients undergoing ERCP with cholangioscopy
|
350 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02543957 |
H-37346 |
|
September 2015 |
September 2018 |
December 2018 |
September 9, 2015 |
January 24, 2018 |
|
- Baylor College of Medicine
Houston, Texas, United States
|
| 19 |
NCT02545309 |
Recruiting |
Secondary Sclerosing Cholangitis in Critically Ill Patients |
- Secondary Sclerosing Cholangitis
|
|
Observational |
|
- Medical University of Graz
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- bile acid transporter genes
- gut permeability
- bile acids
- bone health
|
140 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02545309 |
26-569 ex 13/14 |
SSC-CIP |
January 2015 |
January 2020 |
January 2021 |
September 9, 2015 |
February 12, 2018 |
|
- Department of Internal Medicine, Medical University of Graz
Graz, Austria
|
| 20 |
NCT02736708 |
Recruiting |
Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for PSC Biliary Strictures |
- Primary Sclerosing Cholangitis
|
- Device: probe based confocal laser endomicroscopy
|
Observational |
|
- University of Colorado, Denver
- University of Pittsburgh
- Weill Medical College of Cornell University
- (and 4 more...)
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sensitivity of ERCP with probe-based endomicroscopy
- Differentiation between PSC and PSC-malignant stenosis
- Feasibility of Technical Performance based on image quality
- Feasibility of Technical Performance based on tissue sampling accuracy
|
100 |
All |
18 Years to 89 Years (Adult, Senior) |
NCT02736708 |
12-1516 |
PSCRegistry |
January 2013 |
September 2018 |
September 2018 |
April 13, 2016 |
December 14, 2017 |
|
- University of Colorado
Aurora, Colorado, United States
|
| 21 |
NCT02616705 |
Recruiting |
Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis |
- IgG4-related Sclerosing Cholangitis
- IgG4-related Disease
|
|
Observational |
|
- Mayo Clinic
- Nagoya University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA.
- Correlation between bile and serum IgG4 concentrations.
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT02616705 |
15-004819 |
|
November 2015 |
November 2019 |
November 2019 |
November 30, 2015 |
July 31, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States - Nagoya City Universty Graduate School of Medical Sciences
Nagoya, Japan
|
| 22 |
NCT02516605 |
Recruiting |
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients |
- Primary Biliary Cholangitis
|
- Drug: Part 1: LJN452
- Drug: Part 1: Placebo
- Drug: Part 2: LJN452 Dose level 1
- (and 2 more...)
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in cholestatic markers from baseline
- Number of patients with adverse events, serious adverse events and death
- Change from baseline in disease specific quality of life
- (and 7 more...)
|
163 |
All |
18 Years and older (Adult, Senior) |
NCT02516605 |
CLJN452X2201
2015-001590-41 |
|
September 9, 2015 |
December 10, 2019 |
December 10, 2019 |
August 6, 2015 |
April 19, 2018 |
|
- Novartis Investigative Site
Rialto, California, United States - Novartis Investigative Site
Bradenton, Florida, United States - Novartis Investigative Site
Miami, Florida, United States - (and 26 more...)
|
| 23 |
NCT03422042 |
Recruiting |
Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis |
- Acute Cholangitis
- Common Bile Duct Calculi
|
- Other: Short duration of antibiotic
- Other: Standard treatment of antibiotic
|
Interventional |
Not Applicable |
- Prince of Songkla University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The recurrence rate of cholangitis
- The rate of adequacy of drainage
- Complication rate
- Mortality rate
|
92 |
All |
18 Years and older (Adult, Senior) |
NCT03422042 |
REC 56-124-21-1-2 |
|
February 13, 2013 |
February 20, 2019 |
November 30, 2021 |
February 5, 2018 |
February 7, 2018 |
|
- NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hatyai, Songkla, Thailand
|
| 24 |
NCT02137668 |
Recruiting |
Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin |
- Primary Sclerosing Cholangitis
- Biliary Atresia
|
|
Interventional |
Phase 1 |
- Sacramento Pediatric Gastroenterology
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia
|
200 |
All |
up to 40 Years (Child, Adult) |
NCT02137668 |
Davies 1 |
|
July 2010 |
May 2018 |
July 2028 |
May 14, 2014 |
November 15, 2016 |
|
- Sacramento Pediatric Gastroenterology
Sacramento, California, United States
|
| 25 |
NCT01161992 |
Recruiting |
Genomics of Primary Sclerosing Cholangitis (PSC) |
- Primary Sclerosing Cholangitis (PSC)
|
- Genetic: Genetic Analysis
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Mapping of Susceptibility Genes in Adult Chronic Cholestatic Liver Diseases
|
1500 |
All |
5 Years to 90 Years (Child, Adult, Senior) |
NCT01161992 |
670-02 PSC |
|
March 2002 |
December 2025 |
December 2025 |
July 14, 2010 |
August 22, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
| 26 |
NCT03333928 |
Recruiting |
A POC and Dose-Ranging Study of HTD1801 in PSC Patients |
- Primary Sclerosing Cholangitis (PSC)
|
- Drug: HTD1801
- Drug: Placebo
|
Interventional |
Phase 2 |
- HighTide Biopharma Pty Ltd
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- change of alkaline phosphatase (ALP)
- frequency and severity of adverse events
|
90 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03333928 |
HTD1801.PCT003 |
|
February 9, 2018 |
November 30, 2018 |
April 30, 2019 |
November 7, 2017 |
April 17, 2018 |
|
- University of Colorado, Denver
Aurora, Colorado, United States - University of Miami
Miami, Florida, United States - University of Louisville
Louisville, Kentucky, United States - (and 2 more...)
|
| 27 |
NCT03046901 |
Recruiting |
Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients |
- Primary Sclerosing Cholangitis
- Post- Orthotopic Liver Transplantation
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
|
20 |
All |
Child, Adult, Senior |
NCT03046901 |
Pro00013111 |
|
December 7, 2016 |
August 1, 2017 |
August 1, 2018 |
February 8, 2017 |
February 8, 2017 |
|
- Ochsner Medical Center
New Orleans, Louisiana, United States
|
| 28 |
NCT03104569 |
Recruiting |
Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma |
|
- Procedure: Injection of 37℃ contrast agent
|
Interventional |
Not Applicable |
- Hepatopancreatobiliary Surgery Institute of Gansu Province
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of participants with Acute cholangitis
- The ease of injection
- Number of Participants With Abnormal Laboratory Values
- (and 3 more...)
|
100 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT03104569 |
37℃ Contrast Agent in ERCP |
|
July 1, 2017 |
April 1, 2018 |
April 1, 2018 |
April 7, 2017 |
July 18, 2017 |
|
- The first hospital of Lanzhou university
Lanzhou, Gansu, China - The first affiliated hospital of Xi 'an jiaotong university
Xi'an, Shaanxi, China - Tianjin Nankai Hospital
Tianjin Shi, Tianjin, China
|
| 29 |
NCT02997878 |
Not yet recruiting |
A Single-arm,Phase IIa,Safety and Efficacy Trial of Selected MSCs in the Treatment of Patients With PSC & AiH |
- Cholangitis, Sclerosing
- Hepatitis, Autoimmune
|
|
Interventional |
Phase 1
Phase 2 |
- University of Birmingham
- European Union
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Stage 1- Dose finding and Incidence of treatment emergent adverse events (safety and tolerability) PSC and AiH Patients
- Stage 2: Incidence of treatment emergent adverse events (safety and tolerability) - Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AiH) patients
- Stage 2: Activity: change in Alkaline Phosphatase (ALP) value : ( absolute % change /duration of change between baseline and day 56) - PSC
- (and 8 more...)
|
56 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02997878 |
RG-13-124 |
Merlin |
November 2017 |
June 2019 |
December 2019 |
December 20, 2016 |
August 7, 2017 |
|
|
| 30 |
NCT03301506 |
Recruiting |
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) |
- Primary Biliary Cirrhosis
|
- Drug: Seladelpar 2 mg Capsule
- Drug: Seladelpar 5 mg Capsule
- Drug: Seladelpar 10 mg Capsule
|
Interventional |
Phase 2
Phase 3 |
- CymaBay Therapeutics, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events (AE) and Treatment Emergent Adverse Events (TEAEs), Biochemistry and Hematology and NCI CTCAE Version 4.0
- Laboratory Value: Serum Alkaline Phosphatase (AP)
- Laboratory Value: Aspartate Aminotransferase (AST)
- (and 11 more...)
|
356 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03301506 |
CB8025-31731 |
|
December 12, 2017 |
December 2020 |
March 2022 |
October 4, 2017 |
April 5, 2018 |
|
- Southern California Liver & GI Center
Coronado, California, United States - University of California, Davis Medical Center
Sacramento, California, United States - Digestive Healthcare of Georgia
Atlanta, Georgia, United States - (and 13 more...)
|
| 31 |
NCT02955602 |
Recruiting |
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) |
- Primary Biliary Cirrhosis
|
- Drug: MBX-8025 2 mg Capsule
- Drug: MBX-8025 5 mg Capsule
- Drug: MBX-8025 10 mg Capsule
|
Interventional |
Phase 2 |
- CymaBay Therapeutics, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Serum Alkaline Phosphatase (AP)
- Adverse events (AE) and Treatment Emergent Adverse Events (TEAEs), ECG, biochemistry, hematology and urinalysis (NCI CTCAE Version 4.0)
- Aspartate Aminotransferase (AST)
- (and 22 more...)
|
116 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02955602 |
CB8025-21629 |
|
November 28, 2016 |
July 2019 |
January 2020 |
November 4, 2016 |
April 23, 2018 |
|
- Southern California Research Center
Coronado, California, United States - Standford University Medicine
Palo Alto, California, United States - University of California, Davis Medical Center
Sacramento, California, United States - (and 34 more...)
|
| 32 |
NCT02884557 |
Recruiting |
NKT Role in the Regulation of the Inflammatory Bowel Disease |
- Inflammatory Bowel Diseases
- Primary Sclerosing Cholangitis
|
- Other: collection of gut biopsies collection of blood samples
|
Interventional |
Not Applicable |
- University Hospital, Lille
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- The increase in the expression of the NKT marker Valpha24 mRNA by PCR in the colon of patients with PSC alone, PSC + IBD compared to patients with IBD alone
- The number of NKT infiltrating colonic biopsies, using immunohistochemical staining
- The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02884557 |
2011_06
2012-A00493-40 |
NKT-CSP/MICI |
May 2013 |
September 2019 |
September 2019 |
August 31, 2016 |
February 19, 2018 |
|
- CHRU, Hôpital Claude Huriez
Lille, France
|
| 33 |
NCT02936596 |
Recruiting |
Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome |
- Hepatitis, Autoimmune
- Cholangitis
- Liver Cirrhosis, Biliary
- Cholestasis
|
- Drug: Ursodeoxycholic acid combination of immunosuppressive agents
- Drug: Ursodeoxycholic Acid
|
Interventional |
Not Applicable |
- Xiaoli Fan
- West China Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)
- Alanine transaminase (ALT)
- Aspartate transaminase(AST)
- (and 7 more...)
|
53 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02936596 |
OS-1 |
|
December 2016 |
August 2017 |
|
October 18, 2016 |
December 12, 2016 |
|
- West China Hospital
Chengdu, Sichuan, China
|
| 34 |
NCT03476993 |
Not yet recruiting |
Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis |
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of patients with alkaline phosphatase (ALP) decrease > 40% from Baseline (day 1 week 0) or with normal ALP level (Barcelona criteria) after 24 weeks of treatment with BCD-085 in combination with UDCA.
|
30 |
All |
18 Years to 60 Years (Adult) |
NCT03476993 |
BCD-085-6 |
|
April 2018 |
April 2020 |
December 2021 |
March 26, 2018 |
March 26, 2018 |
|
- State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation
|
| 35 |
NCT02932449 |
Recruiting |
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis |
- Biliary Cirrhosis, Primary
|
|
Observational |
|
- Target PharmaSolutions, Inc.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Other
|
- Evaluate PBC treatment regimens being used in clinical practice
- Examine populations underrepresented in phase III clinical trials
- Examine biochemical response and its association with long term outcomes
- Estimate adverse event frequency and severity and describe management practices
|
1500 |
All |
18 Years and older (Adult, Senior) |
NCT02932449 |
TARGET-PBC |
|
October 2016 |
September 2021 |
September 2021 |
October 13, 2016 |
April 13, 2018 |
|
- Banner University Medical Center
Phoenix, Arizona, United States - Mayo Clinic
Phoenix, Arizona, United States - University of Arkansas
Little Rock, Arkansas, United States - (and 24 more...)
|
| 36 |
NCT03226067 |
Recruiting |
Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid. |
- Primary Biliary Cirrhosis
|
- Drug: GKT137831
- Drug: Placebo oral capsule
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- The percent change in serum GGT.
- Absolute change in serum GGT
- Percent change in serum GGT
- (and 25 more...)
|
102 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03226067 |
GSN000300
2016-004599-23 |
|
June 26, 2017 |
August 20, 2018 |
August 20, 2018 |
July 21, 2017 |
April 26, 2018 |
|
- Mayo Clinic
Phoenix, Arizona, United States - University California Davis
Sacramento, California, United States - Ventura Clinical Trials
Ventura, California, United States - (and 53 more...)
|
| 37 |
NCT03112681 |
Recruiting |
A Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS) |
- Primary Biliary Cirrhosis
|
- Drug: Saroglitazar magnesium 2 mg
- Drug: Saroglitazar magnesium 4 mg
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with Primary Biliary Cholangitis.
|
36 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03112681 |
SARO.16.004.03.PROT |
EPICS |
August 18, 2017 |
January 2019 |
March 2019 |
April 13, 2017 |
April 2, 2018 |
|
- Indiana University School of Medicine
Indianapolis, Indiana, United States - Rutgers NJ Medical School
Newark, New Jersey, United States - Sandra Atlas Bass Center for Liver Diseases- Northwell Health
Manhasset, New York, United States - (and 7 more...)
|
| 38 |
NCT03133026 |
Recruiting |
Cholangioscopic Assessment of Occluded Biliary Stent and Role of Biliary Radiofrequency Ablation |
- Obstructive Jaundice
- Cholangitis
|
- Device: Single operator cholangioscopy, Endoscopic biliary RFA
|
Interventional |
Not Applicable |
- Asian Institute of Gastroenterology, India
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Diagnostic
|
- Successful restoration of bile duct drainage
- Resolution of cholangitis
|
4 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03133026 |
AIG-001 |
|
June 2016 |
June 2018 |
July 2018 |
April 28, 2017 |
April 28, 2017 |
|
- Asian Institute of Gastroenterology
Hyderabad, Telangana, India
|
| 39 |
NCT03146910 |
Recruiting |
Swiss Primary Biliary Cholangitis Cohort Study |
|
|
Observational |
|
- Fondazione Epatocentro Ticino
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Disease course
- Disease features
- Response to treatment
- (and 2 more...)
|
500 |
All |
18 Years and older (Adult, Senior) |
NCT03146910 |
SASL39 - Swiss PBC Cohort |
|
February 15, 2017 |
December 31, 2022 |
December 31, 2022 |
May 10, 2017 |
May 10, 2017 |
|
- Fondazione Epatocentro Ticino
Lugano, Ticino, Switzerland - Inselspital
Bern, Switzerland - Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités
Geneve, Switzerland - (and 3 more...)
|
| 40 |
NCT02618668 |
Recruiting |
Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography |
|
- Drug: Ketamine / Propofol Admixture
- Drug: Propofol
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography
- saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography
- Heart rate( beat/minute) from baseline of patient
- (and 2 more...)
|
90 |
All |
18 Years to 60 Years (Adult) |
NCT02618668 |
Momen01098983009 |
Assiutu |
November 2015 |
July 2017 |
August 2017 |
December 1, 2015 |
August 1, 2017 |
|
- Assiut university hospital
Assiut, Egypt
|
| 41 |
NCT02966834 |
Recruiting |
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis |
|
- Drug: Placebo
- Drug: GSK2330672
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Mean change from Baseline at Week 16 in the Mean Worst Daily Itch Score
- Mean change from Baseline at Week 16 in PBC-40 scale
- Mean change from Baseline at Week 16 in serum alkaline phosphatase (ALP) concentrations, in participants with high risk of PBC progression
- (and 26 more...)
|
118 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02966834 |
201000 |
|
January 11, 2017 |
August 9, 2019 |
August 9, 2019 |
November 17, 2016 |
April 24, 2018 |
|
- GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Sacramento, California, United States - GSK Investigational Site
Miami, Florida, United States - (and 63 more...)
|
| 42 |
NCT02797665 |
Recruiting |
Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids |
- Autoimmune Pancreatitis
- IgG4-related Sclerosing Cholangitis
- Obstructive Jaundice
|
- Drug: corticosteroids
- Procedure: biliary stent
|
Interventional |
Not Applicable |
- Peking Union Medical College Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinical remission rate of obstructive jaundice
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02797665 |
ZS-844 |
|
May 2016 |
April 2019 |
|
June 13, 2016 |
June 13, 2016 |
|
- Peking Union Medical College Hospital
Beijing, Beijing, China
|
| 43 |
NCT02308111 |
Recruiting |
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis |
|
- Drug: Obeticholic Acid (OCA)
- Drug: Placebo
|
Interventional |
Phase 4 |
- Intercept Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Composite endpoint of any of the five listed adjudicated events
- First occurrence of each of the listed individual events
- First occurrence of liver-related death
- (and 14 more...)
|
428 |
All |
18 Years and older (Adult, Senior) |
NCT02308111 |
747-302 |
COBALT |
December 2014 |
December 2024 |
April 2025 |
December 4, 2014 |
March 13, 2018 |
|
- Mayo Clinic
Phoenix, Arizona, United States - Cedars-Sinai Medical Center
Los Angeles, California, United States - Inland Empire Liver Foundation
Rialto, California, United States - (and 156 more...)
|
| 44 |
NCT03337074 |
Recruiting |
Paternally Inherited Phenotypes in Cholestasis |
- Cholestasis
- Primary Sclerosing Cholangitis
- Primary Biliary Cirrhosis
|
- Other: Questionnaire, semen sample, fasting blood sample
- Other: Questionnaire
- Other: Questionnaire, fasting blood sample
|
Observational |
|
- Guy's and St Thomas' NHS Foundation Trust
- King's College Hospital NHS Trust
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Impact of male cholestasis on DNA methylation patterns in sperm
- Impact of male cholestasis on small RNA content in sperm
- Impact of male cholestasis on sperm histone retention
- (and 3 more...)
|
200 |
All |
16 Years and older (Child, Adult, Senior) |
NCT03337074 |
182833 |
PIP-C |
February 8, 2017 |
April 1, 2018 |
April 3, 2020 |
November 8, 2017 |
March 29, 2018 |
|
- Assisted Conception Unit, Guy's Hospital
London, United Kingdom - King's College Hospital
London, United Kingdom
|
| 45 |
NCT03175471 |
Recruiting |
MRI Based Biomarkers in Pediatric Autoimmune Liver Disease |
- Autoimmune Liver Disease
- Primary Sclerosing Cholangitis
- Autoimmune Hepatitis
|
|
Observational |
|
- Children's Hospital Medical Center, Cincinnati
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- MRI based outcomes
- Liver histopathology based assessment of bile duct injury by ISHAK Score
- Liver histopathology based assessment of bile duct injury by Ludwig score
- (and 10 more...)
|
115 |
All |
6 Years to 23 Years (Child, Adult) |
NCT03175471 |
CIN001-MRI biomarkers in AILD |
|
January 17, 2017 |
January 2020 |
January 2021 |
June 5, 2017 |
June 5, 2017 |
|
- Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
|
| 46 |
NCT03178630 |
Recruiting |
MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease |
- Autoimmune Liver Disease
- Autoimmune Hepatitis
- Primary Sclerosing Cholangitis
|
|
Observational |
|
- Children's Hospital Medical Center, Cincinnati
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change of intrahepatic bile duct irregularities between V0 (baseline visit) and V1 (visit after12 months) or V2 (visit after 24 months).
- Change of extra-hepatic duct irregularities between V0 (baseline visit) and V1 (visit after 12 months) or V2 (visit after 24 months).
- Mean shear stiffness of the liver
- (and 10 more...)
|
115 |
All |
6 Years to 23 Years (Child, Adult) |
NCT03178630 |
CIN002 MRI biomarkers in AILD |
|
February 20, 2017 |
February 2030 |
February 2031 |
June 7, 2017 |
August 23, 2017 |
|
- Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States
|
| 47 |
NCT02705638 |
Recruiting |
Treatment of IgG4-Related Disease With Revlimid and Rituximab |
- Immunoglobulin G Subclass 4 Related Disease
- IgG4-related Disease
- Autoimmune Pancreatitis
- (and 2 more...)
|
- Drug: Rituximab
- Drug: Lenalidomide
|
Interventional |
Phase 1 |
- Mayo Clinic
- Celgene Corporation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects in remission for Immunoglobulin G subclass 4 Related Disease at 24 months
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT02705638 |
15-003700 |
TIGR2 |
April 2016 |
April 2019 |
April 2019 |
March 10, 2016 |
February 21, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 48 |
NCT01988506 |
Recruiting |
Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases |
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Systemic Lupus Erythematosus
- (and 11 more...)
|
|
Interventional |
Phase 2 |
- Assistance Publique - Hôpitaux de Paris
- Iltoo Pharma
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentages of Tregs
- CRP, CRP ulta sensible, PCT, Albumin, LDH, anemia
- Number of relapses
- (and 4 more...)
|
132 |
All |
18 Years and older (Adult, Senior) |
NCT01988506 |
P130101
2013-001232-22 |
TRANSREG |
January 6, 2014 |
July 14, 2018 |
February 6, 2020 |
November 20, 2013 |
January 11, 2018 |
|
- Service d' Hépato Gastro Entérologie - Hôpital SAINT-ANTOINE
Paris, Ile De France, France - Service de Gastro Entérologie - Hôpital SAINT-ANTOINE
Paris, Ile De France, France - Service de Rhumatologie - Hôpital SAINT-ANTOINE
Paris, Ile De France, France - (and 8 more...)
|
| 49 |
NCT01438385 |
Recruiting |
Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders |
- Ampullary Cancer
- Duodenal Cancer
- Bile Duct Cancer
- (and 20 more...)
|
- Procedure: Interventional Endoscopy
|
Observational |
|
- Weill Medical College of Cornell University
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Establishing a database that contains all Interventional Endoscopies
|
12000 |
All |
18 Years and older (Adult, Senior) |
NCT01438385 |
1104011642 |
|
July 2011 |
December 30, 2017 |
December 30, 2017 |
September 22, 2011 |
February 20, 2017 |
|
- Weill Cornell Medical College of Cornell University
New York, New York, United States
|
| 50 |
NCT02682368 |
Recruiting |
Multicentric Point of Care UltraSound by Surgeons Trial |
- Biliary Calculi
- Cholecystitis, Acute
- Cholecystitis, Chronic
- (and 7 more...)
|
- Device: Bedside performed Ultrasound Scan by the surgeon
- Other: Radiology report
- Procedure: Intra-operative findings
|
Interventional |
Not Applicable |
- Connolly Hospital Blanchardstown
- Royal College of Surgeons, Ireland
- Modular UltraSound ESTES Course (MUSEC)
- European Society for Trauma and Emergency Surgery (ESTES)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Percentage of diagnoses that match between surgeon performed US and radiologist report.
- Percentage of diagnoses that match between surgeon performed US and postoperative findings.
- Number of hours between US performed by surgeons and radiologist's report.
- Number of hours between US performed by surgeons and postoperative diagnosis.
|
400 |
All |
18 Years to 120 Years (Adult, Senior) |
NCT02682368 |
15190484 |
POCUSS |
October 1, 2015 |
August 30, 2018 |
September 15, 2018 |
February 15, 2016 |
April 5, 2018 |
|
- Connolly Hospital Blanchardstown
Dublin, Dublin 15, Ireland - General Surgery Dept, Minimally Invasive Surgery Unit, Policlinico San Pietro
Ponte San Pietro, Bergamo, Italy - General Surgery Department, ASUITS, Cattinara Hospital
Trieste, Italy - (and 2 more...)
|
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