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Common Bile Duct Pressure After Surgical Exploration

Primary Purpose

Choledocholithiasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cholecystectomy and common bile duct exploration
Sponsored by
Carlos R. Cervantes Sanchez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Choledocholithiasis focused on measuring Choledocholithiasis; common bile duct; cholangiogram.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Choledocholithiasis -

Exclusion Criteria: To not complete the follow-up period

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients with Choledocholithiasis

    Arm Description

    Patients were managed by elective open cholecystectomy and operative exploration of the common bile duct.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 9, 2021
    Last Updated
    July 19, 2021
    Sponsor
    Carlos R. Cervantes Sanchez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04968873
    Brief Title
    Common Bile Duct Pressure After Surgical Exploration
    Official Title
    Common Bile Duct Pressure After Intraoperative Instrumentation in Patients With Uncomplicated Choledocholithiasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2001 (Actual)
    Primary Completion Date
    August 2001 (Actual)
    Study Completion Date
    November 2001 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Carlos R. Cervantes Sanchez

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choledocholithiasis
    Keywords
    Choledocholithiasis; common bile duct; cholangiogram.

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with Choledocholithiasis
    Arm Type
    Experimental
    Arm Description
    Patients were managed by elective open cholecystectomy and operative exploration of the common bile duct.
    Intervention Type
    Procedure
    Intervention Name(s)
    Cholecystectomy and common bile duct exploration
    Intervention Description
    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 Outcome Measure Information:
    Title
    Basal common bile duct (CBD) pressure
    Description
    Basal CBD manometry was obtained immediately after cholecystectomy
    Time Frame
    Intraoperative
    Title
    First week control common bile duct pressure
    Description
    CBD manometry was obtained one week after cholecystectomy
    Time Frame
    First week
    Title
    Second week control common bile duct pressure
    Description
    CBD manometry was obtained two weeks after cholecystectomy
    Time Frame
    Second week
    Title
    Third week control common bile duct pressure
    Description
    CBD manometry was obtained three weeks after cholecystectomy
    Time Frame
    Third week
    Title
    Fourth week control common bile duct pressure
    Description
    CBD manometry was obtained four weeks after cholecystectomy
    Time Frame
    Fourth week
    Title
    Fifth week control common bile duct pressure
    Description
    CBD manometry was obtained five weeks after cholecystectomy
    Time Frame
    Fifth week
    Title
    Sixth week control common bile duct pressure
    Description
    CBD manometry was obtained six weeks after cholecystectomy
    Time Frame
    Sixth week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Choledocholithiasis - Exclusion Criteria: To not complete the follow-up period -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Saldaña-Cortés, MD
    Organizational Affiliation
    General Surgery Service
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    8462367
    Citation
    Mendez-Sanchez N, Jessurun J, Ponciano-Rodriguez G, Alonso-de-Ruiz P, Uribe M, Hernandez-Avila M. Prevalence of gallstone disease in Mexico. A necropsy study. Dig Dis Sci. 1993 Apr;38(4):680-3. doi: 10.1007/BF01316800.
    Results Reference
    background
    Citation
    González-Pérez LG, Zaldívar-Ramírez FR, Tapia-Contla BR, Díaz-Contreras-Piedras CM, Arellano-López PR, Hurtado-López LM. Factores de riesgo de la coledocolitiasis asintomática; experiencia en el Hospital General de México. Cir Gen. 2018;40(3):164-168.
    Results Reference
    background
    PubMed Identifier
    3369934
    Citation
    Csendes A, Sepulveda A, Burdiles P, Braghetto I, Bastias J, Schutte H, Diaz JC, Yarmuch J, Maluenda F. Common bile duct pressure in patients with common bile duct stones with or without acute suppurative cholangitis. Arch Surg. 1988 Jun;123(6):697-9. doi: 10.1001/archsurg.1988.01400300039005.
    Results Reference
    background
    PubMed Identifier
    24141714
    Citation
    World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
    Results Reference
    background
    PubMed Identifier
    499707
    Citation
    Csendes A, Kruse A, Funch-Jensen P, Oster MJ, Ornsholt J, Amdrup E. Pressure measurements in the biliary and pancreatic duct systems in controls and in patients with gallstones, previous cholecystectomy, or common bile duct stones. Gastroenterology. 1979 Dec;77(6):1203-10. No abstract available.
    Results Reference
    background
    PubMed Identifier
    26615165
    Citation
    Copelan A, Kapoor BS. Choledocholithiasis: Diagnosis and Management. Tech Vasc Interv Radiol. 2015 Dec;18(4):244-55. doi: 10.1053/j.tvir.2015.07.008. Epub 2015 Jul 15.
    Results Reference
    result

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    Common Bile Duct Pressure After Surgical Exploration

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