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Completed

NCT Number: NCT05901363

ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy

Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammed Ahmed Omar

Qina, Qena Governorate, 83523, Egypt

About this study

Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.

Single-session treatment of gallbladder and CBD stones is safe, efficient, shortens hospital stay, and is less expensive than staged procedures.

Although there is some evidence suggesting that LCBDE may be associated with a lower rate of retained stones compared with ERCP, previous studies comparing LCBDE with ERCP and stone extraction have collectively failed to demonstrate the superiority of one approach over the other.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with cholecystocholedocholithiasis
  • American Society of Anesthesiologists (ASA) scores of I-III
  • Age 20-70 years.

Exclusion criteria

  • cholangitis,
  • acute biliary pancreatitis,
  • suspected Mirizzi syndrome,
  • suspected hepatobiliary malignancy,
  • perforated gallbladder,
  • biliary peritonitis,
  • intrahepatic stones,
  • pregnancy,
  • previous cholecystectomy,
  • altered anatomy such as Billroth II reconstruction or any form of Roux-en-Y reconstruction that interfere with the endoscopic approach,
  • Contraindications to laparoscopic surgery as severe liver cirrhosis or upper abdominal surgery were excluded.

Treatment and study plan

Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

Procedure

laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones

Other names: ERCP plus LC

aparoscopic common bile duct exploration and laparoscopic cholecystectomy

Procedure

laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones

Other names: LCBDE plus LC

Primary outcomes

  1. success rate

    Time frame: 2 years

    successful laparoscopic cholecystectomy and successful common bile duct stone extraction

Secondary outcomes

  1. operative time

    Time frame: from 1 to 5 hours

    the overall time of the procedure

  2. morbidity

    Time frame: 3 years

    any intraoperative or postoperative adverse event

  3. mortality

    Time frame: 3 years

    death of patient

  4. Hospital stay

    Time frame: 30 days

    the length of hospital stay from the day of admission to the day of discharge

  5. the number of hospital readmission

    Time frame: 3 years

  6. the number of postoperative intervention

    Time frame: 3 years

  7. The total cost of treatment

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy for Cholecystocholedocholithiasis - The Same Operator: A Multicenter Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 13, 2023
Registry last updated
Jun 13, 2023

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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