Common Bile Duct GallstonesNCT01189734
Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
A study testing laparoscopic common bile duct exploration and laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy in people with Common Bile Duct Gallstones, run by Mansoura University at 1 site in Egypt.
Trial summary
Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Common Bile Duct Gallstones
- What is being tested?
- laparoscopic common bile duct exploration and laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteEgypt
- Study dates
- Start not givento not given
- 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 12 to 90 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- preoperatively diagnosed common bile duct stones
Who cannot join
- liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gastroenterology Surgical Center
Al Mansurah, Dakahlia Governorate, 35516
About this study
Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.
- Conditions
- Common Bile Duct Gallstones
- Being tested
- laparoscopic common bile duct exploration, laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy
- Keywords
- common bile duct stones, laparoscopic common bile duct exploration, intraoperative ercp, Preoperatively diagnosed 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.
laparoscopic common bile duct explorationProcedure or surgery
laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic common bile duct exploration | Placebo comparator | Not described Receives: Procedure: laparoscopic common bile duct exploration |
| laparoscopic cholecystectomy with intraoperative ES | Active comparator | Not described Receives: Procedure: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
success/failure of common bile duct removal
Secondary outcomes (1)
Surgical time
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)
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189734
- Sponsor's protocol ID
- LCBDEIOES
- Status last verified
- Feb 2010
- First submitted
- 25 Aug 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
- Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
- ClinicalTrials.gov ID
- NCT01189734
- Acronym / sponsor ID
- LCBDEIOES
- Conditions
- Common Bile Duct Gallstones
- Keywords
- common bile duct stones, laparoscopic common bile duct exploration, intraoperative ercp, Preoperatively diagnosed common bile duct stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- 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.
Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic common bile duct exploration | Placebo comparator | Procedure: laparoscopic common bile duct exploration |
| laparoscopic cholecystectomy with intraoperative ES | Active comparator | Procedure: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- preoperatively diagnosed common bile duct stones
Key exclusion criteria (1 listed)
- liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy
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 |
|---|---|---|
| laparoscopic common bile duct exploration | Procedure or surgery | laparoscopic common bile duct exploration |
| laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy | Procedure or surgery | laparoscopic cholecystectomy with intraoperative ES |
Primary outcome
success/failure of common bile duct removal
1 secondary outcome
Surgical time
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 laparoscopic common bile duct exploration and laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy 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 of common bile duct 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; AzTrials last refreshed its copy on 26 Oct 2026.