Common Bile Duct Pressure After Surgical Exploration

Not Applicable

Completed

• Conditions: Choledocholithiasis
• Interventions: Procedure: Cholecystectomy and common bile duct exploration

• Registration Number: NCT04968873
• Lead Sponsor: Carlos R. Cervantes Sanchez

Brief Summary

A study that included patients of any gender between 15 and 70 years, with the diagnosis of choledocholithiasis who required a cholecystectomy with an exploration of bile ducts. Conventional cholecystectomy was performed and a T-tube was inserted in the common bile duct (CBD) to measure the intraluminal pressure immediately after the procedure, and weekly thereafter, with a 6-week follow-up. A control T-tube radiological study was performed at six weeks to exclude residual stones.

Detailed Description

A clinical, controlled, prospective, longitudinal, descriptive, observational and double-blinded study was designed. Patients of any gender between 15 and 70 years, with a diagnosis of choledocholithiasis, and who required a cholecystectomy with an exploration of bile ducts were included. Conventional cholecystectomy was performed and perioperative T-tube CBD pressure was registered immediately after the procedure, and weekly thereafter, with a 6-week follow-up.

Control T-tube cholangiogram was performed at six weeks to exclude residual stones. Data was analyzed with T-test for parametric values.

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2001-08
• Study Completion: 2001-11
• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Choledocholithiasis -

Exclusion Criteria

To not complete the follow-up period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Choledocholithiasis	Cholecystectomy and common bile duct exploration	Patients were managed by elective open cholecystectomy and operative exploration of the common bile duct.

Primary Outcome Measures

Name	Time	Method
First week control common bile duct pressure	First week	CBD manometry was obtained one week after cholecystectomy
Basal common bile duct (CBD) pressure	Intraoperative	Basal CBD manometry was obtained immediately after cholecystectomy
Second week control common bile duct pressure	Second week	CBD manometry was obtained two weeks after cholecystectomy
Third week control common bile duct pressure	Third week	CBD manometry was obtained three weeks after cholecystectomy
Fifth week control common bile duct pressure	Fifth week	CBD manometry was obtained five weeks after cholecystectomy
Fourth week control common bile duct pressure	Fourth week	CBD manometry was obtained four weeks after cholecystectomy
Sixth week control common bile duct pressure	Sixth week	CBD manometry was obtained six weeks after cholecystectomy