Common Bile Duct Stones.NCT01046552
Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones
A study testing preoperative ERCP and LC and Intraoperative ERCP and LC in people with Common Bile Duct Stones., run by Mansoura University at 1 site in Egypt.
Trial summary
ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP. 210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients). Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Common Bile Duct Stones.
- What is being tested?
- preoperative ERCP and LC and Intraoperative ERCP and LC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2006to Sep 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with gallstones and common bile duct stones
Who cannot join
- contraindications to ercp
- contraindication to laparoscopy
- biliary pancreatitis
- refusal to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ahmed Abdel-Raouf El-Geidie
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis
ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP.
210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients).
The total hospital stay were significantly shorter in the group of LC/IOES
- Conditions
- Common Bile Duct Stones.
- Being tested
- preoperative ERCP and LC, Intraoperative ERCP and LC
- Keywords
- Choledocholithias, Common bile duct stones, Endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy, Preoperative, intraoperative, Laparoscopic common bile duct exploration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative ERCP and LCProcedure or surgery
preoperative ERCP followed by LC
Intraoperative ERCP and LCProcedure or surgery
LC and intraoperative ERCP
| Study group | Role | What they receive |
|---|---|---|
| PES/LC | Active comparator | preoperative ES followed by LC within the same hospital admission Receives: Procedure: preoperative ERCP and LC |
| LC/IOES | Active comparator | laparoscopic cholecystectomy with intraoperative ercp under the same anesthesia Receives: Procedure: Intraoperative ERCP and LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance of stones from the common bile duct
Measured: 6 months
Secondary outcomes (1)
bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJun 2006
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct Stones.Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046552
- Sponsor's protocol ID
- ERCP123
- Status last verified
- Sep 2009
- First submitted
- 5 Jan 2010
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis
- ClinicalTrials.gov ID
- NCT01046552
- Acronym / sponsor ID
- ERCP123
- Conditions
- Common Bile Duct Stones.
- Keywords
- Choledocholithias, Common bile duct stones, Endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy, Preoperative, intraoperative, Laparoscopic common bile duct exploration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 12 Jan 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.
ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP.
210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients).
The total hospital stay were significantly shorter in the group of LC/IOES
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PES/LC | Active comparator | Procedure: preoperative ERCP and LCpreoperative ES followed by LC within the same hospital admission |
| LC/IOES | Active comparator | Procedure: Intraoperative ERCP and LClaparoscopic cholecystectomy with intraoperative ercp under the same anesthesia |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with gallstones and common bile duct stones
Key exclusion criteria (4 listed)
- contraindications to ercp
- contraindication to laparoscopy
- biliary pancreatitis
- refusal to participate
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 |
|---|---|---|
| preoperative ERCP and LCpreoperative ERCP followed by LC | Procedure or surgery | PES/LC |
| Intraoperative ERCP and LCLC and intraoperative ERCP | Procedure or surgery | LC/IOES |
Primary outcome
clearance of stones from the common bile duct
Time frame: 6 months
1 secondary outcome
bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy
Time frame: 6 months
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 12 Jan 2010.
- mansoura universityLink provided by the sponsor.
Related trials for Common Bile Duct Stones.
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ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
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Recruiting
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
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 preoperative ERCP and LC and Intraoperative ERCP and LC in people with Common Bile Duct Stones., 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 4 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 12 Jan 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. 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?
clearance of stones from the common bile duct (time frame: 6 months). 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 Jan 2010.