Complications of Surgical and Medical Care: General TermsloopNCT02232451
Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique
A study testing ERCP with loop tip wire and ERCP for cannulation in people with Complications of Surgical and Medical Care: General Terms, run by Azienda Ospedaliera San Paolo.
Trial summary
The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Complications of Surgical and Medical Care: General Terms
- What is being tested?
- ERCP with loop tip wire and ERCP for cannulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Aug 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high risk patients for post-ERCP pancreatitis
Who cannot join
- age < 18 yrs
- allergy to the contrast medium
- previous surgery
- neoplastic bilio-pancreatic disease
- previous EBS
About this study
Official title: Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients
The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.
Read the detailed description
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients.
Type of study: Multicentric, prospective and randomized trial
Patients: PEP high-risk patients underwent ERCP for benign biliary pathology
Number of patients: 320 patients (160 for each group)
Aim:
Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.
- Being tested
- ERCP with loop tip wire, ERCP for cannulation
- Keywords
- loop, ERCP, cannulation, biliary, wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with loop tip wireDevice
Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation
ERCP for cannulationDevice
Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation
| Study group | Role | What they receive |
|---|---|---|
| ERCP with loop tip wire | Experimental | ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis. Receives: Device: ERCP with loop tip wire |
| ERCP for cannulation | Active comparator | ERCP for cannulation of CBD with traditional technique Receives: Device: ERCP for cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the incidence of PEP
Measured: loop20216
Secondary outcomes (1)
The evaluation of CBD percentage cannulation.
Measured: loop20216
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startNov 2010
- Primary completionJun 2012
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of Surgical and Medical Care: General TermsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Paolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enzo Masci, Azienda Ospedaliera San Paolo
- Investigators
- Enzo Masci, MD, Study director, Hospital San Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232451
- Sponsor's protocol ID
- loop20216
- Acronym
- loop
- Status last verified
- Sep 2014
- First submitted
- 1 Aug 2012
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients
- ClinicalTrials.gov ID
- NCT02232451
- Acronym / sponsor ID
- loop / loop20216
- Keywords
- loop, ERCP, cannulation, biliary, wire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San PaoloUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Sep 2014 (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 purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.
Detailed description
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients.
Type of study: Multicentric, prospective and randomized trial
Patients: PEP high-risk patients underwent ERCP for benign biliary pathology
Number of patients: 320 patients (160 for each group)
Aim:
Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP with loop tip wire | Experimental | Device: ERCP with loop tip wireERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis. |
| ERCP for cannulation | Active comparator | Device: ERCP for cannulationERCP for cannulation of CBD with traditional technique |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high risk patients for post-ERCP pancreatitis
Key exclusion criteria (5 listed)
- age < 18 yrs
- allergy to the contrast medium
- previous surgery
- neoplastic bilio-pancreatic disease
- previous EBS
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 loop tip wireEndoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation | Device | ERCP with loop tip wire |
| ERCP for cannulationEndoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation | Device | ERCP for cannulation |
Primary outcome
The evaluation of the incidence of PEP
Time frame: loop20216
1 secondary outcome
The evaluation of CBD percentage cannulation.
Time frame: loop20216
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 25 Sep 2014.
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.
Enzo Masci, MD study director
Hospital San Paolo
Questions about this trial
What is this clinical trial studying?
A study testing ERCP with loop tip wire and ERCP for cannulation in people with Complications of Surgical and Medical Care: General Terms, run by Azienda Ospedaliera San Paolo.
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 5 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 25 Sep 2014. 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 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?
The evaluation of the incidence of PEP (time frame: loop20216). 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 25 Sep 2014.