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Common Bile Duct Pressure After Surgical Exploration

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04968873
Enrollment
13
Registered
2021-07-20
Start date
2001-03-01
Completion date
2001-11-01
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis

Keywords

Choledocholithiasis; common bile duct; cholangiogram.

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.

Interventions

PROCEDURECholecystectomy 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.

Sponsors

Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Choledocholithiasis -

Exclusion criteria

To not complete the follow-up period \-

Design outcomes

Primary

MeasureTime frameDescription
Basal common bile duct (CBD) pressureIntraoperativeBasal CBD manometry was obtained immediately after cholecystectomy
First week control common bile duct pressureFirst weekCBD manometry was obtained one week after cholecystectomy
Second week control common bile duct pressureSecond weekCBD manometry was obtained two weeks after cholecystectomy
Third week control common bile duct pressureThird weekCBD manometry was obtained three weeks after cholecystectomy
Fourth week control common bile duct pressureFourth weekCBD manometry was obtained four weeks after cholecystectomy
Fifth week control common bile duct pressureFifth weekCBD manometry was obtained five weeks after cholecystectomy
Sixth week control common bile duct pressureSixth weekCBD manometry was obtained six weeks after cholecystectomy

Contacts

PRINCIPAL_INVESTIGATORDavid Saldaña-Cortés, MD

General Surgery Service

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026