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

NCT03658863 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-10-07

No results posted yet for this study

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

Interventions

PROCEDURE

endoscopic ultrasound

Evaluation of bile ducts with endoscope with special ultrasonographic function

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

DEVICE

Ultrasound endoscope

Endoscope with built-in ultrasound function

Sponsors & Collaborators

  • Vilnius University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658863 on ClinicalTrials.gov