Common Bile Duct Pressure After Surgical Exploration

Choledocholithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04968873
• Other study ID #: 2001/0023
• Status: Completed
• Phase: N/A
• Start date: March 2001
• Est. completion date: November 2001

Study information

• Verified date: July 2021
• Source: Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2001
• Est. primary completion date: August 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria: Choledocholithiasis -

Exclusion Criteria: To not complete the follow-up period

-

Related Conditions & MeSH terms

• Choledocholithiasis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carlos R. Cervantes Sanchez

References & Publications (6)

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. Review. — View 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. — View Citation

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. — View 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.

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. — View 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. — View Citation

Outcome

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