Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

"Endoscopy First" or "Laparoscopic Cholecystectomy First" for Patients With Intermediate Risk of Choledocholithiasis

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: NCT03658863
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ausra Aleknaite, Vilnius University

Brief Summary:

The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated.

Endosonoscopic evaluation of bile ducts and endoscopic retrograde cholangiography (ERCP) on demand are performed before laparoscopic cholecystectomy for one arm. Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative ERCP on demand are administered in another arm.


Condition or disease Intervention/treatment Phase
Choledocholithiasis Procedure: endoscopic ultrasound Procedure: intraoperative cholangiography Procedure: ERCP Device: Ultrasound endoscope Not Applicable

Detailed Description:

Use of ERCP as a diagnostic tool should be minimized as it carries considerable risk (5 to 10%) of post-procedural complications. It is noticed that adverse events occur more often to patients with low risk of choledocholithiasis. Therefore the best possible patient selection for ERCP procedure is needed.

At the Centre of Abdominal Surgery of Vilnius University Hospital Santaros klinikos an original prognostic index (Vilnius University Hospital index (VUHI)) is used for evaluation of risk of choledocholithiasis. It is calculated by formula VUHI = A/30 + 0.4×B, where A - total bilirubin concentration (µmol/l), B - common bile duct (CBD) diameter measured by ultrasound exam. A retrospective study evaluated its accuracy and determined threshold values for low, intermediate and high risk groups. The intermediate risk group (risk for choledocholithiasis 25-75%) would benefit from additional examination before ERCP. Endoscopic ultrasound (EUS) and intraoperative cholangiography are less invasive procedures with high accuracy identifying common bile duct stones. Main hypothesis of the trial is that intraoperative cholangiography with ERCP on demand can shorten the duration and costs of treatment and avoid diagnostic ERCPs.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Endoscopy first
Endoscopic ultrasound is used to evaluate bile ducts. If stones in extrahepatic bile ducts are seen ERCP and stone evacuation is performed during the same anaesthesia. Laparoscopic cholecystectomy is performed after endoscopic procedures in two days.
Procedure: endoscopic ultrasound
Evaluation of bile ducts with endoscope with special ultrasonographic function

Procedure: ERCP
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
Other Name: endoscopic retrograde cholangiopancreatography

Device: Ultrasound endoscope
Endoscope with built-in ultrasound function
Other Name: Endosonoscope

Active Comparator: Cholecystectomy first
Laparoscopic cholecystectomy with intraoperative cholangiography is performed. If stones are found postoperative ERCP with stone evacuation is applied (during cholecystectomy if common bile duct is completely blocked or as soon as possible).
Procedure: intraoperative cholangiography
evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy

Procedure: ERCP
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
Other Name: endoscopic retrograde cholangiopancreatography




Primary Outcome Measures :
  1. Duration of treatment [ Time Frame: up to one month ]
    duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days


Secondary Outcome Measures :
  1. Accuracy of different management strategies [ Time Frame: 6 to 7 months ]
    Proportion of correctly diagnosed (true positive and true negative) cases in all sample

  2. Technical success of interventions (IOC, EUS, ERCP) [ Time Frame: up to one month ]

    For intraoperative cholangiography: successful cannulation and contrast media injection into CBD.

    For endoscopic sonoscopy: successful visualisation of CBD.

    For ERCP: successful cannulation and contrast media injection into CBD.


  3. Adverse events of interventions [ Time Frame: up to one month ]
    Bleeding, acute pancreatitis, perforation, allergic reactions

  4. Costs of treatment [ Time Frame: up to one month ]
    charges of diagnostic procedures, invasive procedures, surgery, antibacterial treatment if needed and hospital charges



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with cholecystolithiasis when laparoscopic cholecystectomy is indicated
  • intermediate risk for choledocholithiasis (VUHI 2,6 - 6,9 and one of the predictors: dilated common bile duct, elevated total bilirubin or suspected stone in CBD on ultrasound)

Exclusion Criteria:

  • pregnancy;
  • acute cholangitis;
  • biliary pancreatitis;
  • acute cholecystitis, degree II-III by Tokyo guidelines 2013;
  • anastomosis in upper gastrointestinal tract;
  • other known cholestatic hepatopancreatobiliary disease;
  • known or suspected hepatitis of another origin (viral, toxic, etc.);
  • contraindications for general anaesthesia or surgery;
  • IV-VI class of American Society of Anesthesiologists physical status classification;
  • morbid obesity (body mass index > 40);
  • patient's refusal to participate in the study.

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): NCT03658863


Locations
Layout table for location information
Lithuania
Vilnius University Hospital Santaros Klinikos Recruiting
Vilnius, Lithuania
Contact: Gintaras Simutis, MD, PhD    +370 5 236 5255    gintaras.simutis@santa.lt   
Contact: Ausra Aleknaite, MD    +370 618 18076    ausra.aleknaite@santa.lt   
Sponsors and Collaborators
Vilnius University

Layout table for additonal information
Responsible Party: Ausra Aleknaite, Investigator, Vilnius University
ClinicalTrials.gov Identifier: NCT03658863     History of Changes
Other Study ID Numbers: TLA02
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ausra Aleknaite, Vilnius University:
choledocholithiasis
endoscopic ultrasound
ERCP
intraoperative cholangiography
common bile duct stone
endoscopic retrograde cholangiopancreatography
gallstone disease
cholelithiasis
bile duct obstruction
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Layout table for MeSH terms
Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis