PancreatitisRELGNCT02290769
Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire
A study testing Short guide wire rapid exchange and Long guide wire in people with Pancreatitis, run by Niguarda Hospital at 1 site in Italy.
Trial summary
The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Short guide wire rapid exchange and Long guide wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jan 2018to 14 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication to primary ERCP
- ASA (American Society of Anesthesiologists) 1, 2, 3
Who cannot join
- pancreas neoplasia
- pancreatitis
- ampulloma
- duodenum stenosis
- under mucous membrane haematoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial
The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.
Read the detailed description
In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis.
Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients
- Conditions
- Pancreatitis
- Being tested
- Short guide wire rapid exchange, Long guide wire
- Keywords
- Guide wire cannulation ERCP, Time of cannulation, Rapid exchange guide wire, Guide wire
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short guide wire rapid exchangeDevice
Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
Long guide wireDevice
Use of long wire to guide the cannulation during primary ERCP
| Study group | Role | What they receive |
|---|---|---|
| Short guide wire rapid exchange | Experimental | Use of short guide wire rapid exchange to guide the cannulation during primary ERCP Receives: Device: Short guide wire rapid exchange |
| Long guide wire | Active comparator | Use of long wire to guide the cannulation during primary ERCP Receives: Device: Long guide wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of cannulation
Time (in seconds) required to perform a complete and successful deep cannulation of the "biliary papilla" and the biliary tree assessed by timing it and reporting it in the prefashioned database
Measured: 8 hours from intervention
Secondary outcomes (1)
Incidence of post ERCP pancreatitis
Incidence of post ERCP pancreatitis
Measured: 8 hours post ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study start28 Jan 2018
- Primary completion28 Jan 2018
- Study completion14 Dec 2026 (estimated)
Why it stopped: Hospital administrative problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Pugliese, MD, Study chair, Niguarda Ca' Granda HospitalEdoardo Forti, MD, Study chair, Niguarda Ca' Granda HospitalRaffaele Manta, MD, Study chair, Niguarda Ca' Granda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290769
- Sponsor's protocol ID
- 382 - 072014
- Acronym
- RELG
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2014
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02290769
- Acronym / sponsor ID
- RELG / 382 - 072014
- Conditions
- Pancreatitis
- Keywords
- Guide wire cannulation ERCP, Time of cannulation, Rapid exchange guide wire, Guide wire
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Hospital administrative problems
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 14 Nov 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 aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.
Detailed description
In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis.
Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short guide wire rapid exchange | Experimental | Device: Short guide wire rapid exchangeUse of short guide wire rapid exchange to guide the cannulation during primary ERCP |
| Long guide wire | Active comparator | Device: Long guide wireUse of long wire to guide the cannulation during primary ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication to primary ERCP
- ASA (American Society of Anesthesiologists) 1, 2, 3
Key exclusion criteria (5 listed)
- pancreas neoplasia
- pancreatitis
- ampulloma
- duodenum stenosis
- under mucous membrane haematoma
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 |
|---|---|---|
| Short guide wire rapid exchangeUse of short guide wire rapid exchange to guide the cannulation during primary ERCP | Device | Short guide wire rapid exchange |
| Long guide wireUse of long wire to guide the cannulation during primary ERCP | Device | Long guide wire |
Primary outcome
Time of cannulation
Time frame: 8 hours from intervention
Time (in seconds) required to perform a complete and successful deep cannulation of the "biliary papilla" and the biliary tree assessed by timing it and reporting it in the prefashioned database
1 secondary outcome
Incidence of post ERCP pancreatitis
Time frame: 8 hours post ERCP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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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.
Francesco Pugliese, MD study chair
Niguarda Ca' Granda Hospital
Edoardo Forti, MD study chair
Niguarda Ca' Granda Hospital
Raffaele Manta, MD study chair
Niguarda Ca' Granda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short guide wire rapid exchange and Long guide wire in people with Pancreatitis, run by Niguarda Hospital at 1 site in Italy.
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 2 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: paused, as of the sponsor's last update on 16 Apr 2026. 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 Italy. 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?
Results are not available in the source record.
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?
Time of cannulation (time frame: 8 hours from intervention). 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 16 Apr 2026.