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NCT Number: NCT02460315

Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

early cholecystectomy

Procedure

Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 1 will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP

Other names: G 1

late cholecystectomy

Procedure

Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 2 will be managed by late LC one month after ERCP.

Other names: G 2

Primary outcomes

  1. conversion rate to open

    Time frame: 1 day

    number of patients underwent conversion to open

Secondary outcomes

  1. signs of inflammation (redness, pus)

    Time frame: 30 days

    signs of inflammation redness, pus, wall thickness

  2. postoperative morbidity

    Time frame: 1 days

    postoperative morbidity

  3. degree of adhesion (mild,moderate, severe)

    Time frame: 1 days

    degree of adhesions

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones by Endoscopic Retrograde Cholangiopancreatography

Acronym: ERCP

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
Jun 2, 2015

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.