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Completed

NCT Number: NCT04968873

Common Bile Duct Pressure After Surgical Exploration

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Choledocholithiasis -

Exclusion criteria

To not complete the follow-up period

-

Treatment and study plan

Cholecystectomy and common bile duct exploration

Procedure

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.

Primary outcomes

  1. Basal common bile duct (CBD) pressure

    Time frame: Intraoperative

    Basal CBD manometry was obtained immediately after cholecystectomy

  2. First week control common bile duct pressure

    Time frame: First week

    CBD manometry was obtained one week after cholecystectomy

  3. Second week control common bile duct pressure

    Time frame: Second week

    CBD manometry was obtained two weeks after cholecystectomy

  4. Third week control common bile duct pressure

    Time frame: Third week

    CBD manometry was obtained three weeks after cholecystectomy

  5. Fourth week control common bile duct pressure

    Time frame: Fourth week

    CBD manometry was obtained four weeks after cholecystectomy

  6. Fifth week control common bile duct pressure

    Time frame: Fifth week

    CBD manometry was obtained five weeks after cholecystectomy

  7. Sixth week control common bile duct pressure

    Time frame: Sixth week

    CBD manometry was obtained six weeks after cholecystectomy

Sponsors and collaborators

Lead sponsor

Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo

Other Gov

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Jul 20, 2021
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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