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

NCT ID: NCT04475796

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Choledocholithiasis With Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early group

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy performed after ERCP

Delayed group

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy performed after ERCP

Interventions

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Laparoscopic cholecystectomy

Laparoscopic cholecystectomy performed after ERCP

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Aouf

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Aouf, Dr.

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

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Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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124569124569

Identifier Type: -

Identifier Source: org_study_id

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