Common Bile Duct Pressure After Surgical Exploration

July 19, 2021 updated by: Carlos R. Cervantes Sanchez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Choledocholithiasis -

Exclusion Criteria: To not complete the follow-up period

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with Choledocholithiasis
Patients were managed by elective open cholecystectomy and operative exploration of the common bile duct.
Procedure: Cholecystectomy and common bile duct exploration
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos R. Cervantes Sanchez

Investigators

  • Principal Investigator: David Saldaña-Cortés, MD, General Surgery Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2001

Primary Completion (ACTUAL)

August 1, 2001

Study Completion (ACTUAL)

November 1, 2001

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (ACTUAL)

July 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001/0023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data (IPD) that underlie results in a publication

IPD Sharing Time Frame

When summary data are published

IPD Sharing Access Criteria

All information should be requested from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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