CBD Repair Over T-tube or Primary Repair

• Conditions: CBD Exploration
• Interventions: Device: T-tube

• Registration Number: NCT04108780
• Lead Sponsor: Assiut University

Brief Summary

the aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after exploration common bile duct stones

Detailed Description

Common Bile Duct Exploration is a surgery that involves opening the main bile duct that drains from liver and gallbladder into the first part of the small intestine (the duodenum). This is needed when a gallstone drops out of the gallbladder into the duct and partially or completely blocks up the duct. This can cause jaundice , fever and chills, severe abdominal pain due to infection / inflammation of the bile duct, gallbladder or pancreas. This most often involves admission to the hospital and urgent intervention. Most commonly, a procedure called an ERCP is used to clear out the stones from the bile duct. If gallbladder will have to be removed soon to prevent this potentially serious condition from occurring again.

During the operation the investigators remove gallbladder then a duct exploration is performed. This involves opening the duct directly and removing the stones.

Prior to Common Bile Duct Exploration surgery, patient will be asked not to eat anything after midnight prior to the surgery. patient will be given specific instructions from the surgeon or anesthesiologist about which medications he should or should not take prior to the surgery. patient should not take any blood thinning medications at least 5 days prior to your operation. This should be discussed with the surgeon at the preop visit.

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09-25
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30
• Primary Completion: 2022-03-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who will undergo common bile duct exploration

Exclusion Criteria

• patients who has failed ERCP for management of common bile duct exploration
• CBD diameter 2 cm or more

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CBD exploration with primary repair	T-tube	primary repair of CBD after CBD exploration
CBD exploration with T-tube	T-tube	repair of CBD after CBD exploration over T-tube

Primary Outcome Measures

Name	Time	Method
bile leak from common bile duct	baseline	Assessment which type of repair (with T-tube or primary repair) bile leak will occurs more

Secondary Outcome Measures

Name	Time	Method
hospital stay length	base line	Assessment which type of repair (with T-tube or primary repair) patient will stay in the hospital more after CBD exploration