Common Bile Duct Pressure After Surgical Exploration

• Sponsor: Carlos R. Cervantes Sanchez (Other)
• Overall Status: Completed
• CT.gov ID: NCT04968873
• Collaborator: (none)
• Enrollment: 13
• Arm: 1
• Actual Duration (Months): 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Choledocholithiasis	Procedure: Cholecystectomy and common bile duct exploration	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Common Bile Duct Pressure After Intraoperative Instrumentation in Patients With Uncomplicated Choledocholithiasis
• Actual Study Start Date: Mar 1, 2001
• Actual Primary Completion Date: Aug 1, 2001
• Actual Study Completion Date: Nov 1, 2001

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Basal common bile duct (CBD) pressure [Intraoperative]

   Basal CBD manometry was obtained immediately after cholecystectomy

2. First week control common bile duct pressure [First week]

   CBD manometry was obtained one week after cholecystectomy

3. Second week control common bile duct pressure [Second week]

   CBD manometry was obtained two weeks after cholecystectomy

4. Third week control common bile duct pressure [Third week]

   CBD manometry was obtained three weeks after cholecystectomy

5. Fourth week control common bile duct pressure [Fourth week]

   CBD manometry was obtained four weeks after cholecystectomy

6. Fifth week control common bile duct pressure [Fifth week]

   CBD manometry was obtained five weeks after cholecystectomy

7. Sixth week control common bile duct pressure [Sixth week]

   CBD manometry was obtained six weeks after cholecystectomy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: Choledocholithiasis -

Exclusion Criteria: To not complete the follow-up period

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Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Carlos R. Cervantes Sanchez

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Csendes A, Sepúlveda A, Burdiles P, Braghetto I, Bastias J, Schütte H, Díaz 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.
• 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.
• Méndez-Sánchez N, Jessurun J, Ponciano-Rodríguez G, Alonso-de-Ruiz P, Uribe M, Hernández-Avila M. Prevalence of gallstone disease in Mexico. A necropsy study. Dig Dis Sci. 1993 Apr;38(4):680-3.
• 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.

• Responsible Party: Carlos R. Cervantes Sanchez, General Surgery Service, Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
• ClinicalTrials.gov Identifier: NCT04968873
• Other Study ID Numbers: 2001/0023
• First Posted: Jul 20, 2021
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carlos R. Cervantes Sanchez, General Surgery Service, Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo: Choledocholithiasis; common bile duct; cholangiogram.
• Additional relevant MeSH terms: Choledocholithiasis

Study Results

No Results Posted as of Jul 20, 2021