Common Bile Duct Pressure After Surgical Exploration

NCT04968873 | Completed

• 1 other identifier: 2001/0023
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Choledocholithiasis

Keywords

Choledocholithiasis; common bile duct; cholangiogram.

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Patients with Choledocholithiasis

EXPERIMENTAL

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

Procedure: Cholecystectomy and common bile duct exploration

Interventions

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.

Patients with Choledocholithiasis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo: lead

Related Publications (6)

• 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.

  PMID: 8462367 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 3369934 BACKGROUND

• 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.

  PMID: 24141714 BACKGROUND

• 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.

  PMID: 499707 BACKGROUND

• 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.

  PMID: 26615165 RESULT

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• David Saldaña-Cortés, MD

  General Surgery Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Service

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: March 1, 2001
• Primary Completion: August 1, 2001
• Study Completion: November 1, 2001
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When summary data are published
• Access Criteria: All information should be requested from the corresponding author.