One Session Vs Staged Management of Calcular Obstructive Jaundice

Minia University

Status: Enrolling

Conditions: Gall Bladder Disease; Calcular Obstructive Jaundice

Treatments: Procedure: one session ERCP then LC; Procedure: staged managment; Procedure: one session LC then ERCP

Study type: Interventional

Funder types: Other

Identifiers

NCT05979233

fac.med.23.42

Details and patient eligibility

About

to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management

Full description

to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age from 18-70 year
• combined CBD and gall stone
• stone less than 1.5 cm
• fit for surgery
• no upper abdominal surgery

Exclusion criteria

• age <18 and >70
• unfit for surgery
• stone more than 1.5 cm
• upper abdominal surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 3 patient groups

staged managment

Active Comparator group

Description:

ERCP then interval laparoscopic cholecystectomy

Treatment:

Procedure: staged managment

one session ERCP then LC

Experimental group

Description:

one session ERCP then LC

Treatment:

Procedure: one session ERCP then LC

one session LC then ERCP

Experimental group

Description:

one session LC then ERCP

Treatment:

Procedure: one session LC then ERCP