ClinicalTrials.Veeva

Menu

Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones (ERCP)

M

Mansoura University

Status

Completed

Conditions

Gallbladder and Bile Duct Calculi

Treatments

Procedure: late cholecystectomy
Procedure: early cholecystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02460315
timing of cholecystectomy

Details and patient eligibility

About

Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD) stones. However CBD stones can also be formed in the absence of gallbladder stones. The current standard of treatment for calcular obstructive jaundice is endoscopic removal of the stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for patients with CBDS. Stone extraction is successful in up to 97% of patients The time interval between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may vary from days to months. Some retrospective and other prospective studies have investigated this issue without sharp clue or definite conclusion This study planned to compare early LC (within admission) versus late LC (after 1 month) after ERCP as regard technical difficulties and surgical outcomes.

Full description

The aim is comparing early versus delayed laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography in patients with gall bladder stones and calcular obstructive jaundice as regards operative difficulties, conversion rate, signs of inflammation, degree of adhesions, blood loss, postoperative morbidity, and hospital stay. Moreover, bacterial examination of bile and culture sensitivity test for assessment of bacterial colonization and relate the degree of colonization to timing of laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography, to decide upon the optimal timing for the surgery.

The study population will be divided into 2 groups; group (A) will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP and group (B) will be managed by late LC one month after ERCP.

Enrollment

50 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with CBD stone and treated by ERCP

Exclusion criteria

  • Patient unfit for surgery,
  • Pregnant patients,
  • Patients with severe malnutrition,
  • Patients with liver cirrhosis,
  • Patients in whom endoscopic management of CBD stones failed
  • Patients who experienced pancreatitis or perforation as a complication of the endoscopic management of CBD stones
  • Patients who underwent previous upper abdominal surgeries
  • Mentally retarded patients.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

early cholecystectomy
Active Comparator group
Description:
group (A) will be managed by early laparoscopic cholecystectomy after clearness ERCP
Treatment:
Procedure: early cholecystectomy
late cholecystectomy
Active Comparator group
Description:
group (B) will be managed by late LC one month after ERCP.
Treatment:
Procedure: late cholecystectomy

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems