Common Bile Duct Pressure After Surgical Exploration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Common Bile Duct Pressure After Intraoperative Instrumentation in Patients With Uncomplicated Choledocholithiasis

Conditions
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Choledocholithiasis

Intervention / Treatment
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* Procedure: Cholecystectomy and common bile duct exploration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Choledocholithiasis - Exclusion Criteria: To not complete the follow-up period -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Choledocholithiasis<br>Patients were managed by elective open cholecystectomy and operative exploration of the common bile duct. | Procedure: Cholecystectomy and common bile duct exploration<br>* During elective open cholecystectomy, a basal commcn dile duct (CBD) manometry was obtained immediately after cholecystectomy, with a 10 Fr. silicone T tube introduced into the cystic duct and connected to a glass manometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal common bile duct (CBD) pressure | Basal CBD manometry was obtained immediately after cholecystectomy | Intraoperative | 
| First week control common bile duct pressure | CBD manometry was obtained one week after cholecystectomy | First week | 
| Second week control common bile duct pressure | CBD manometry was obtained two weeks after cholecystectomy | Second week | 
| Third week control common bile duct pressure | CBD manometry was obtained three weeks after cholecystectomy | Third week | 
| Fourth week control common bile duct pressure | CBD manometry was obtained four weeks after cholecystectomy | Fourth week | 
| Fifth week control common bile duct pressure | CBD manometry was obtained five weeks after cholecystectomy | Fifth week | 
| Sixth week control common bile duct pressure | CBD manometry was obtained six weeks after cholecystectomy | Sixth week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choledocholithiasis; common bile duct; cholangiogram.