CholedocholithiasisNCT00612846
Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients
A study testing Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy and Laparoscopic bile duct exploration during cholecystectomy in people with Choledocholithiasis and Higher Risk Patients, run by North Bristol NHS Trust.
Trial summary
The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Choledocholithiasis, Higher Risk Patients
- What is being tested?
- Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy and Laparoscopic bile duct exploration during cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Mar 2000to Mar 2006
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gallbladder stones
- At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct)
- Higher risk (>70yrs, >60yrs with co-morbidity, >50 with BMI>40)
Who cannot join
- Not fit for general anaesthesia
- Cholangitis requiring emergency ERCP
- Previous upper GI surgery making ERCP impossible
About this study
Official title: A Randomised Clinical Trial to Compare Endoscopic Sphincterotomy and Subsequent Laparoscopic Cholecystectomy With Primary Laparoscopic Bile Duct Exploration During Cholecystectomy in Higher Risk Patients With Choledocholithiasis
The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.
- Conditions
- Choledocholithiasis, Higher Risk Patients
- Being tested
- Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy, Laparoscopic bile duct exploration during cholecystectomy
- Keywords
- Common Bile Duct Calculi, Choledocholithiasis, Endoscopic sphincterotomy, Cholecystectomy, laparoscopic, Laparoscopic bile duct exploration
- Medical subject headings
- Choledocholithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomyProcedure or surgery
Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
Laparoscopic bile duct exploration during cholecystectomyProcedure or surgery
Laparoscopic bile duct exploration during cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy |
| B | Experimental | Not described Receives: Procedure: Laparoscopic bile duct exploration during cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bile duct clearance
Measured: Peri-operative
Secondary outcomes (4)
Morbidity and mortality
Measured: 30 day or directly relating to intervention
Post-operative stay
Measured: Post-operative stay
Procedures per patient
Measured: Interventions required to acheive duct clearance
Conversion to open surgery
Measured: Peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startMar 2000
- Primary completionMar 2006
- Study completionMar 2006
Why it stopped: Terminated early due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Bristol NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Michael H Thompson, MD, FRCS, Study director, North Bristol NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612846
- Sponsor's protocol ID
- 112/99
- Status last verified
- Jan 2008
- First submitted
- 29 Jan 2008
- Last updated
- 12 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial to Compare Endoscopic Sphincterotomy and Subsequent Laparoscopic Cholecystectomy With Primary Laparoscopic Bile Duct Exploration During Cholecystectomy in Higher Risk Patients With Choledocholithiasis
- ClinicalTrials.gov ID
- NCT00612846
- Acronym / sponsor ID
- 112/99
- Conditions
- Choledocholithiasis, Higher Risk Patients
- Keywords
- Common Bile Duct Calculi, Choledocholithiasis, Endoscopic sphincterotomy, Cholecystectomy, laparoscopic, Laparoscopic bile duct exploration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to slow recruitment
- Enrolment
- 91 participants (actual)
- Lead sponsor
- North Bristol NHS TrustUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 12 Feb 2008 (estimated)
- 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.
The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy |
| B | Experimental | Procedure: Laparoscopic bile duct exploration during cholecystectomy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gallbladder stones
- At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct)
- Higher risk (>70yrs, >60yrs with co-morbidity, >50 with BMI>40)
Key exclusion criteria (3 listed)
- Not fit for general anaesthesia
- Cholangitis requiring emergency ERCP
- Previous upper GI surgery making ERCP impossible
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 |
|---|---|---|
| Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomyEndoscopic sphincterotomy and subsequent laparoscopic cholecystectomy | Procedure or surgery | A |
| Laparoscopic bile duct exploration during cholecystectomyLaparoscopic bile duct exploration during cholecystectomy | Procedure or surgery | B |
Primary outcome
Bile duct clearance
Time frame: Peri-operative
4 secondary outcomes
Morbidity and mortality
Time frame: 30 day or directly relating to intervention
Post-operative stay
Time frame: Post-operative stay
Procedures per patient
Time frame: Interventions required to acheive duct clearance
Conversion to open surgery
Time frame: Peri-operative
Results and safety
The study was stopped early (reason given: Terminated early due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2008.
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ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
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Cholecystectomy, Gallbladder
RecruitingObservational study
Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
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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.
Michael H Thompson, MD, FRCS study director
North Bristol NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy and Laparoscopic bile duct exploration during cholecystectomy in people with Choledocholithiasis and Higher Risk Patients, run by North Bristol NHS Trust.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Feb 2008. 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 was stopped early (reason given: Terminated early due to slow recruitment). Results are not available in the source record.
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?
Bile duct clearance (time frame: Peri-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2008.