Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones

Choledocholithiasis With Cholecystitis Clinical Trial

Official title:

Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475796
• Other study ID #: 124569124569
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2020
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.

Description:

Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new parameters like Nassar scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP

Exclusion Criteria:

• advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.

Related Conditions & MeSH terms

• Cholecystitis
• Choledocholithiasis
• Choledocholithiasis With Cholecystitis
• Gallstones

Intervention

Procedure:
• Laparoscopic cholecystectomy
Laparoscopic cholecystectomy performed after ERCP

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafr Al Sheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	the time to perform laparoscopic cholecystectomy from the time of incision to the last suture	one day
Secondary	intraoperative difficulty and complications	the difficulties that face the surgeon during the surgery and the early complications that result	one day