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Completed

NCT Number: NCT06599437

For Patients with Stones in Gallbladder and Bile Duct Stones At the Same Time, Surgical Removal of the Gallbladder with the Laparoscope is Done in the Same Admission Compared to Its Removal After 6 Weeks Following Successful Removel of the Stones from the Bile Ducts by the Side View Endoscope

The goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after ERCP. The main questions it aims to answer are: laparoscopic cholecystectomy

* Does index laparoscopic cholecystectomy associate with less recurrence of biliary complications? * Is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ERCP to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes.

Participants will:

Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.

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Key information

Conditions

Choledocholithiasis With Cholecystitis Bile Duct Diseases Biliary Tract Diseases Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhur Medical National Institute

Damanhur, Beheira, 22951, Egypt

About this study

The study population of this randomized controlled trial study is those who underwent CBD stone clearance by ERCP. The included fifty patients were stratified randomly into two groups: early and delayed.

Randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. Laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from CBD while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home.

Laparoscopic cholecystectomy was performed by the same surgical team for both groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with concomitant gallbladder and common bile duct stone who underwent clearance of common bile duct stones by ERCP

Exclusion criteria

patients with any of the following:

  • Severe pancreatitis
  • Suspicion of post-ERCP bleeding or perforation,
  • Associated malignancy
  • Those in whom ERCP failed to clear the CBD stones

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.

Late laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.

Primary outcomes

  1. recurrence of biliary events

    Time frame: up to 3 months after surgery

    the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy

Secondary outcomes

  1. operative time

    Time frame: during surgery

    time from the first incision of skin to skin closure and completion of surgery

  2. pancreatitis

    Time frame: 3 months after surgery

    acute inflammation of the pancreas : abdominal pain, elevated lipase and amylase ( more than 3 folds) and/or findings specific for the pancreatitits on imaging.

  3. conversion to open surgery

    Time frame: During surgery

    termination of the laparoscopic procedure and perfome the surgery by the conventional open surgery

  4. Bleeding

    Time frame: during surger and up to 3 weeks

    Intraoperative or postoperative bleeding that requires blood transfusion

  5. the presence of intraoperative adhesions

    Time frame: During surgery

    Adhesions around the gallbladder and at the Calot's triangle

  6. Bile leak

    Time frame: up to 1 week after surgery

    the leak of bile through the drain or intraabdominally

  7. Wound infection

    Time frame: up to 3 months after surgery

    Any evidence of infection in the wounds : redness, pain or discharge of infected fluids from the wounds

  8. hospital stays

    Time frame: from admission to the end of post operative follow up at 3 months after surgery

    the sum the length of stay after ERCP and laparoscopic cholecystectomy including readmission for complication management

  9. post oprative pain

    Time frame: after surgery and up to 3 days

    the degree pain described by the patients after surgery on the visual rating scale

Sponsors and collaborators

Lead sponsor

Damanhour Medical National Institute

Other Gov

Registry information

Official study title

Index Laparoscopic Cholecystectomy Following Clearance of Common Bile Duct Stones Via Endoscopic Retrograde Cholangiography

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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