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CompletedNCT04968873Updated May 18, 2026

Common Bile Duct Pressure After Surgical Exploration

An interventional study of Cholecystectomy and common bile duct exploration in Choledocholithiasis, sponsored by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 20 years 4 months after the study started (first participant enrolled Mar 2001, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Choledocholithiasis

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Keywords

  • Choledocholithiasis; common bile duct; cholangiogram.
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In context

Choledocholithiasis

109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.

This study's enrollment of 13 is below the median of 100 across 76 interventional studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Choledocholithiasis -

Exclusion Criteria: To not complete the follow-up period

-

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • 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

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.

06

What researchers measure

Primary outcomes

  1. Basal common bile duct (CBD) pressure

    Basal CBD manometry was obtained immediately after cholecystectomy

    Time frame: Intraoperative

  2. First week control common bile duct pressure

    CBD manometry was obtained one week after cholecystectomy

    Time frame: First week

  3. Second week control common bile duct pressure

    CBD manometry was obtained two weeks after cholecystectomy

    Time frame: Second week

  4. Third week control common bile duct pressure

    CBD manometry was obtained three weeks after cholecystectomy

    Time frame: Third week

  5. Fourth week control common bile duct pressure

    CBD manometry was obtained four weeks after cholecystectomy

    Time frame: Fourth week

  6. Fifth week control common bile duct pressure

    CBD manometry was obtained five weeks after cholecystectomy

    Time frame: Fifth week

  7. Sixth week control common bile duct pressure

    CBD manometry was obtained six weeks after cholecystectomy

    Time frame: Sixth week

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 8462367 ↗
  • 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.
  • 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. PubMed 3369934 ↗
  • 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. PubMed 24141714 ↗
  • 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. PubMed 499707 ↗
  • 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. PubMed 26615165 ↗

Individual participant data

Plan to share: Yes — All individual participant data (IPD) that underlie results in a publication

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: When summary data are published

Access criteria: All information should be requested from the corresponding author.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04968873
Lead sponsor
Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
Responsible party
Carlos R. Cervantes Sanchez, MD, MSc (General Surgery Service, Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo) — Principal investigator
First posted
Jul 20, 2021
Start date
Mar 2001
Primary completion
Aug 2001
Completion
Nov 2001
Last update
May 18, 2026

Study contacts

David Saldaña-Cortés, MD
principal investigator · General Surgery Service

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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