Common Bile Duct GallstonesNCT01190332
Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography
A study testing endoscopic sphincterotomy by conventional method and endoscopic sphincterotomy by rendezvous method in people with Common Bile Duct Gallstones, run by Mansoura University at 1 site in Egypt.
Trial summary
One of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. It can be performed by many techniques. In the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Common Bile Duct Gallstones
- What is being tested?
- endoscopic sphincterotomy by conventional method and endoscopic sphincterotomy by rendezvous method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2007to Mar 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with MRCP evidence of common bile duct stones
Who cannot join
- cholangitis pancreatitis ASA GRADE III, IV Unfit for laparoscopy unfit for ERCP
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gastroenterology Surgical Center
Al Mansurah, Dakahlia Governorate, 35516
About this study
One of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. It can be performed by many techniques. In the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy.
- Conditions
- Common Bile Duct Gallstones
- Being tested
- endoscopic sphincterotomy by conventional method, endoscopic sphincterotomy by rendezvous method
- Keywords
- common bile duct stones
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic sphincterotomy by conventional methodProcedure or surgery
endoscopic sphincterotomy by rendezvous methodProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| conventional technique of ERCP | Placebo comparator | Not described Receives: Procedure: endoscopic sphincterotomy by conventional method |
| Rendezvous technique | Active comparator | Not described Receives: Procedure: endoscopic sphincterotomy by rendezvous method |
What is being measured
The primary outcome is the main question the study is designed to answer.
success/failure rate of common bile duct stones removal
Secondary outcomes (1)
complication rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startOct 2007
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct GallstonesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190332
- Sponsor's protocol ID
- 7918
- Status last verified
- Feb 2010
- First submitted
- 6 Jul 2010
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT01190332
- Acronym / sponsor ID
- 7918
- Conditions
- Common Bile Duct Gallstones
- Keywords
- common bile duct stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Aug 2010 (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.
One of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. It can be performed by many techniques. In the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional technique of ERCP | Placebo comparator | Procedure: endoscopic sphincterotomy by conventional method |
| Rendezvous technique | Active comparator | Procedure: endoscopic sphincterotomy by rendezvous method |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with MRCP evidence of common bile duct stones
Key exclusion criteria (1 listed)
- cholangitis pancreatitis ASA GRADE III, IV Unfit for laparoscopy unfit for ERCP
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 by conventional method | Procedure or surgery | conventional technique of ERCP |
| endoscopic sphincterotomy by rendezvous method | Procedure or surgery | Rendezvous technique |
Primary outcome
success/failure rate of common bile duct stones removal
1 secondary outcome
complication rate
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 27 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic sphincterotomy by conventional method and endoscopic sphincterotomy by rendezvous method in people with Common Bile Duct Gallstones, run by Mansoura University at 1 site in Egypt.
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 1 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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
success/failure rate of common bile duct stones removal. 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 27 Aug 2010.