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

Choledocholithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03658863
• Other study ID #: TLA02
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: December 15, 2020

Study information

• Verified date: October 2019
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Choledocholithiasis

Intervention

Procedure:
• endoscopic ultrasound
Evaluation of bile ducts with endoscope with special ultrasonographic function
• intraoperative cholangiography
evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy
• ERCP
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum

Device:
• Ultrasound endoscope
Endoscope with built-in ultrasound function

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of treatment	duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days	up to one month
Secondary	Accuracy of different management strategies	Proportion of correctly diagnosed (true positive and true negative) cases in all sample	6 to 7 months
Secondary	Technical success of interventions (IOC, EUS, ERCP)	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
Secondary	Adverse events of interventions	Bleeding, acute pancreatitis, perforation, allergic reactions	up to one month
Secondary	Costs of treatment	charges of diagnostic procedures, invasive procedures, surgery, antibacterial treatment if needed and hospital charges	up to one month