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

NCT03658863 | Unknown

• 1 other identifier: TLA02
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Choledocholithiasis

Keywords

choledocholithiasis; endoscopic ultrasound; ERCP; intraoperative cholangiography; common bile duct stone; endoscopic retrograde cholangiopancreatography; gallstone disease; cholelithiasis; bile duct obstruction; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Duration of treatment

  duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days

  up to one month

Secondary Outcomes (4)

• Accuracy of different management strategies

  6 to 7 months

• Technical success of interventions (IOC, EUS, ERCP)

  up to one month

• Adverse events of interventions

  up to one month

• Costs of treatment

  up to one month

Study Arms (2)

Endoscopy first

ACTIVE COMPARATOR

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; Procedure: ERCP; Device: Ultrasound endoscope

Cholecystectomy first

ACTIVE COMPARATOR

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; Procedure: ERCP

Interventions

endoscopic ultrasound PROCEDURE

Evaluation of bile ducts with endoscope with special ultrasonographic function

Endoscopy first

intraoperative cholangiography PROCEDURE

evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy

Cholecystectomy first

ERCP PROCEDURE

evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum

Also known as: endoscopic retrograde cholangiopancreatography

Cholecystectomy first; Endoscopy first

Ultrasound endoscope DEVICE

Endoscope with built-in ultrasound function

Also known as: Endosonoscope

Endoscopy first

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

RECRUITING

Related Publications (1)

• Aleknaite A, Simutis G, Stanaitis J, Jucaitis T, Drungilas M, Valantinas J, Strupas K. Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 4;10(2):e18837. doi: 10.2196/18837.

  PMID: 33538700 DERIVED

MeSH Terms

Conditions

Choledocholithiasis; Gallstones; Cholelithiasis; Cholestasis

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Digestive System Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: September 5, 2018
• Study Start: December 15, 2017
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

LI (1)