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Trial record 30 of 883 for:    Liver Transplant

POCS in Liver Transplantation Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03205072
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers.

Condition or disease Intervention/treatment
Liver Transplant; Complications Device: Spy Glass DS

Detailed Description:
The objective of this study is to demonstrate the clinical utility of cholangioscopy with Spy Glass Digital System (DS) in cadaveric donor or live donor liver transplantation patients who are referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct stricture(s). A secondary study objective is to generate a hypothesis for a randomized controlled trial comparing ERCP alone to ERCP with Per- Oral Cholangioscopy (POCS) in patients referred for ERCP post liver transplantation.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Per-Oral Cholangioscopy in Liver Transplantation Patients
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ERCP & Spy Glass DS
Patients with cadaveric donor or live donor liver transplantation referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct strictures.
Device: Spy Glass DS
The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.




Primary Outcome Measures :
  1. Impact of Per-Oral Cholangioscopy on Patient Management [ Time Frame: 12 Months ]
    To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications.


Secondary Outcome Measures :
  1. Technical Success [ Time Frame: 12 Months ]
    Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology.

  2. Serious Adverse Events [ Time Frame: 12 Months ]
    Serious Adverse Events (SAEs) including severity, onset, time to resolution, required interventions, relatedness to endoscopic devices and/or procedures and hospitalizations.

  3. Number of biliary re-interventions [ Time Frame: 12 Months ]
    Re-interventions may include but are not limited to repeat ERCP, repeat POCS, ultrasonography, stent exchanges, balloon dilations and liver biopsy.

  4. Patient Management [ Time Frame: 3 and 12 Months ]
    Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate.

  5. Relationship between endoscopic findings on POCS visualization [ Time Frame: 12 Months ]
    Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up.

  6. Evaluation [ Time Frame: 12 Months ]
    Evaluation by surgeon of whether or not POCS impacted patient management post procedure.


Biospecimen Retention:   Samples Without DNA
Biopsies if needed at the discretion of the PI.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cadaveric donor or live donor liver transplantation patients referred for ERCP in the setting of a clinical suspicion of post-liver transplant bile duct stricture(s).
Criteria

Inclusion Criteria:

  1. Liver transplantation at least 1 month prior to POCS procedure
  2. Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms
  3. Prior cross sectional imaging (MRI and/or US and/or CT)
  4. Suspicion of anastomotic biliary stricture(s)
  5. Diameter of bile ducts deemed sufficient to accommodate cholangioscopy system based on baseline imaging
  6. Willing and able to provide a written informed consent to participate in the study
  7. Willing and able to comply with study procedures and follow-up schedule

Exclusion Criteria:

  1. Contraindication for an ERCP per local standard of practice
  2. Deemed contraindicated for POCS per local standard of practice
  3. Prior biliary treatment of biliary anastomotic stricture
  4. < 18 years old
  5. Documented life expectancy of less than 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205072


Contacts
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Contact: Velina Chavarro 508-683-4139 velina.chavarro@bsci.com
Contact: Srey Yin 508-683-4162 srey.yin@bsci.com

Locations
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United States, New York
New York Presbyterian Hospital CUMC Recruiting
New York, New York, United States, 10032
Contact: Amrita Sethi, MD    212-305-2862    as3614@cumc.columbia.edu   
Principal Investigator: Amrita Sethi, MD         
Sub-Investigator: Jean D Edmond, MD         
Sub-Investigator: Elizabeth C Verna, MD         
Sub-Investigator: Amit Sachdev, MD         
Sub-Investigator: Jeffrey Adler, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Adam Slivka, MD    412-647-8132    slivkaa@upmc.edu   
Principal Investigator: Adam Slivka, MD, PhD         
Sub-Investigator: Christopher Hughes, MD         
Sub-Investigator: Mordechai Rabinovitz, MD         
Sub-Investigator: Georgios Papachrisou, MD         
Sub-Investigator: Jennifer Chennat, MD         
Sub-Investigator: Asif Khalid, MD         
Brazil
Hospital Israelita Albert Einstein Not yet recruiting
São Paulo, Brazil, 04026
Contact: Angelo P Ferrari, MD    551121519884    angelo.ferrari@einstein.br   
Principal Investigator: Angelo P Ferrari, MD         
Sub-Investigator: Fernanda P Martins, MD         
Sub-Investigator: Erika P Macedo, MD         
Hospital das Clinicas Not yet recruiting
São Paulo, Brazil, 05403
Contact: Eduardo De Moura, MD    551126616460    eduardo.ghmoura@hc.fm.usp.br   
Principal Investigator: Eduardo De Moura, MD         
Sub-Investigator: Wellington Andraus, MD         
Sub-Investigator: Luiz A D'Albuquerque, MD         
Sub-Investigator: Hugo G Guedes, MD         
Sub-Investigator: Diogo T.H. De Moura, MD         
Spain
Hospital Clinic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Andres Cardenas, MD    34932275513    acardena@clinic.ub.es   
Principal Investigator: Andres Cardenas, MD         
Sub-Investigator: Nidal Mawasi, MD         
Sub-Investigator: Karina Chavez, MD         
Sweden
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden, 14186
Contact: Urban Arnelo, MD    46858580000    Urban.Arnelo@ki.se   
Principal Investigator: Urban Arnelo, MD         
Sub-Investigator: Greg Nowak, MD         
Sub-Investigator: Karouk Said, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Amrita Sethi, MD Columbia University
Principal Investigator: Eduardo De Moura, MD Hospital das Clinicas University of Sao Paulo
Principal Investigator: Eduardo De Moura, MD Hospital das Clinicas
Principal Investigator: Angelo P Ferrari, MD Hospital Israelita Albert Einstein
Principal Investigator: Adam Slivka, MD University of Pittsburgh Medical Center
Principal Investigator: Andres Cardenas, MD Hospital Clinic of Barcelona
Principal Investigator: Urban Arnelo, MD Karolinska University Hospital

Additional Information:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03205072     History of Changes
Other Study ID Numbers: E7114
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston Scientific Corporation:
ERCP
Per-Oral Cholangioscopy
Liver Transplantation
Spy Glass

Additional relevant MeSH terms:
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Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors