CholedocholithiasisNCT04968873
Common Bile Duct Pressure After Surgical Exploration
A study testing Cholecystectomy and common bile duct exploration in people with Choledocholithiasis, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- Cholecystectomy and common bile duct exploration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Nov 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Common Bile Duct Pressure After Intraoperative Instrumentation in Patients With Uncomplicated Choledocholithiasis
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.
- Conditions
- Choledocholithiasis
- Being tested
- Cholecystectomy and common bile duct exploration
- Keywords
- Choledocholithiasis; common bile duct; cholangiogram.
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecystectomy and common bile duct explorationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Choledocholithiasis | Experimental | Patients were managed by elective open cholecystectomy and operative exploration of the common bile duct. Receives: Procedure: Cholecystectomy and common bile duct exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal common bile duct (CBD) pressure
Basal CBD manometry was obtained immediately after cholecystectomy
Measured: Intraoperative
First week control common bile duct pressure
CBD manometry was obtained one week after cholecystectomy
Measured: First week
Second week control common bile duct pressure
CBD manometry was obtained two weeks after cholecystectomy
Measured: Second week
Third week control common bile duct pressure
CBD manometry was obtained three weeks after cholecystectomy
Measured: Third week
Fourth week control common bile duct pressure
CBD manometry was obtained four weeks after cholecystectomy
Measured: Fourth week
Fifth week control common bile duct pressure
CBD manometry was obtained five weeks after cholecystectomy
Measured: Fifth week
Sixth week control common bile duct pressure
CBD manometry was obtained six weeks after cholecystectomy
Measured: Sixth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study startMar 2001
- Primary completionAug 2001
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Carlos R. Cervantes Sanchez, MD, MSc, Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
- Investigators
- David Saldaña-Cortés, MD, Principal investigator, General Surgery Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968873
- Sponsor's protocol ID
- 2001/0023
- Status last verified
- May 2026
- First submitted
- 9 Jul 2021
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in a publication
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 8462367González-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 3369934World 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 24141714Csendes 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 499707Copelan 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Bile Duct Pressure After Intraoperative Instrumentation in Patients With Uncomplicated Choledocholithiasis
- ClinicalTrials.gov ID
- NCT04968873
- Acronym / sponsor ID
- 2001/0023
- Conditions
- Choledocholithiasis
- Keywords
- Choledocholithiasis; common bile duct; cholangiogram.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán AnchondoOther government
- Study start
- Mar 2001 (actual)
- Primary completion
- Aug 2001 (actual)
- Study completion
- Nov 2001 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Choledocholithiasis | Experimental | Procedure: Cholecystectomy and common bile duct explorationPatients were managed by elective open cholecystectomy and operative exploration of the common bile duct. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecystectomy and common bile duct explorationDuring 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. | Procedure or surgery | Patients with Choledocholithiasis |
Primary outcome
Basal common bile duct (CBD) pressure
Time frame: Intraoperative
Basal CBD manometry was obtained immediately after cholecystectomy
First week control common bile duct pressure
Time frame: First week
CBD manometry was obtained one week after cholecystectomy
Second week control common bile duct pressure
Time frame: Second week
CBD manometry was obtained two weeks after cholecystectomy
Third week control common bile duct pressure
Time frame: Third week
CBD manometry was obtained three weeks after cholecystectomy
Fourth week control common bile duct pressure
Time frame: Fourth week
CBD manometry was obtained four weeks after cholecystectomy
Fifth week control common bile duct pressure
Time frame: Fifth week
CBD manometry was obtained five weeks after cholecystectomy
Sixth week control common bile duct pressure
Time frame: Sixth week
CBD manometry was obtained six weeks after cholecystectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 8462367Mendez-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.
- BackgroundGonzález-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: PubMed 3369934Csendes 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.
- Background: PubMed 24141714World 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.
- Background: PubMed 499707Csendes 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.
- Results publication: PubMed 26615165Copelan 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.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication
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Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Saldaña-Cortés, MD principal investigator
General Surgery Service
Questions about this trial
What is this clinical trial studying?
A study testing Cholecystectomy and common bile duct exploration in people with Choledocholithiasis, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal common bile duct (CBD) pressure (time frame: Intraoperative). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968873, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.