Gallstones Complicated by CBD StonesNCT02889471
Routine Nasobiliary Insertion During ERCP in High Risk Patients.
A study testing ERCP with NB and ERCP alone in people with Gallstones Complicated by CBD Stones, run by Minia University at 1 site in Egypt.
Trial summary
110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy admitted to departement of surgery of Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gallstones Complicated by CBD Stones
- What is being tested?
- ERCP with NB and ERCP alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Aug 2017
- 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 GB stone complicated with CBD stones
- accept to share in the study
- the presence of one or more preoperative predictors for high risk for difficult cholecystectomy
- patient fit for LC
Who cannot join
- patients< 18 and >80
- unfit for surgery
- didn't accept to share in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine Nasobiliary Insertion During ERCP to Prevent, Diagnose and Treat of Biliary Injury in High Risk Patients.
110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy admitted to departement of surgery of Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and methylene blue injected at the end of the procedure to detected any leak in NB group
Read the detailed description
110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy as , age > 65 , male sex, obesity, acute cholecystitis, previous upper abdominal surgery, and certain ultrasonographic findings i.e. distended gall bladder (GB), thickened GB wall, pericholecystic fluid collection and impacted stone etc. these patients admitted to department of surgery of Minia university hospital for ERCP followed with laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP to settle high up in the intrahepatic biliary tree after complete CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. sequential, multiple, step after step, tans-nasobiliary Intraoperative cholangiography was done during every step in cholecystectomy especially during dissection of calot's triangle and just before clipping of supposed cystic duct (CD) to make sure that the structure supposed to be CD was not the CBD. after the end of procedure methylene blue is injected from the the NB to detected any leak and if present
- Conditions
- Gallstones Complicated by CBD Stones
- Being tested
- ERCP with NB, ERCP alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with NBProcedure or surgery
ERCP with NB catheter for introperative tans-nasobiliary cholangiography
ERCP aloneProcedure or surgery
ERCP alone followed with standard laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| ERCP with nasobiliary catheter | Experimental | Not described Receives: Procedure: ERCP with NB |
| ERCP only | Active comparator | Not described Receives: Procedure: ERCP alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
biliary injury
the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative
Measured: 2 weeks
conversion to open
incidence of conversion to open
Measured: 6 hours
Secondary outcomes (3)
operative time
operative time from skin incision till closure
Measured: 6 hours
hospital stay
time of hospital stay
Measured: one month
mortality
incidence of operative related mortality
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startApr 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallstones Complicated by CBD StonesStudies of the same condition, open and under way.
- More trials run by Minia 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889471
- Sponsor's protocol ID
- fac.med.07
- Status last verified
- Feb 2018
- First submitted
- 30 Aug 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Nasobiliary Insertion During ERCP to Prevent, Diagnose and Treat of Biliary Injury in High Risk Patients.
- ClinicalTrials.gov ID
- NCT02889471
- Acronym / sponsor ID
- fac.med.07
- Conditions
- Gallstones Complicated by CBD Stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 5 Sep 2016 (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.
110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy admitted to departement of surgery of Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and methylene blue injected at the end of the procedure to detected any leak in NB group
Detailed description
110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy as , age > 65 , male sex, obesity, acute cholecystitis, previous upper abdominal surgery, and certain ultrasonographic findings i.e. distended gall bladder (GB), thickened GB wall, pericholecystic fluid collection and impacted stone etc. these patients admitted to department of surgery of Minia university hospital for ERCP followed with laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP to settle high up in the intrahepatic biliary tree after complete CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. sequential, multiple, step after step, tans-nasobiliary Intraoperative cholangiography was done during every step in cholecystectomy especially during dissection of calot's triangle and just before clipping of supposed cystic duct (CD) to make sure that the structure supposed to be CD was not the CBD. after the end of procedure methylene blue is injected from the the NB to detected any leak and if present
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP with nasobiliary catheter | Experimental | Procedure: ERCP with NB |
| ERCP only | Active comparator | Procedure: ERCP alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with GB stone complicated with CBD stones
- accept to share in the study
- the presence of one or more preoperative predictors for high risk for difficult cholecystectomy
- patient fit for LC
Key exclusion criteria (3 listed)
- patients< 18 and >80
- unfit for surgery
- didn't accept to share in the study
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 |
|---|---|---|
| ERCP with NBERCP with NB catheter for introperative tans-nasobiliary cholangiography | Procedure or surgery | ERCP with nasobiliary catheter |
| ERCP aloneERCP alone followed with standard laparoscopic cholecystectomy | Procedure or surgery | ERCP only |
Primary outcome
biliary injury
Time frame: 2 weeks
the incidence of biliary injury complicating cholecystectomy either discovered intraoperative or postoperative
conversion to open
Time frame: 6 hours
incidence of conversion to open
3 secondary outcomes
operative time
Time frame: 6 hours
hospital stay
Time frame: one month
mortality
Time frame: one month
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 Feb 2018.
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 ERCP with NB and ERCP alone in people with Gallstones Complicated by CBD Stones, run by Minia 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 4 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: finished, as of the sponsor's last update on 12 Feb 2018. 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?
biliary injury (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 2018.