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
About this trial
This is an interventional screening trial for Choledocholithiasis focused on measuring Choledocholithiasis; common bile duct; cholangiogram.
Eligibility Criteria
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
NCT ID
NCT04968873
First Posted
July 9, 2021
Last Updated
July 19, 2021
Sponsor
Carlos R. Cervantes Sanchez
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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