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

October 3, 2019 updated by: Ausra Aleknaite, Vilnius University

Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • endoscopic retrograde cholangiopancreatography
Device: Ultrasound endoscope
Endoscope with built-in ultrasound function
Other Names:
  • 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: ERCP
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
Other Names:
  • endoscopic retrograde cholangiopancreatography
Procedure: intraoperative cholangiography
evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of treatment
Time Frame: up to one month
duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days
up to one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of different management strategies
Time Frame: 6 to 7 months
Proportion of correctly diagnosed (true positive and true negative) cases in all sample
6 to 7 months
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.
up to one month
Adverse events of interventions
Time Frame: up to one month
Bleeding, acute pancreatitis, perforation, allergic reactions
up to one month
Costs of treatment
Time Frame: up to one month
charges of diagnostic procedures, invasive procedures, surgery, antibacterial treatment if needed and hospital charges
up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Anticipated)

December 15, 2020

Study Completion (Anticipated)

December 15, 2020

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLA02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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