Common Bile Duct DiseasesNCT02596646
Early Precut in Difficult Biliary Cannulation
A study testing Early Precut and Prolonged cannulation attempts in people with Common Bile Duct Diseases, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Common Bile Duct Diseases
- What is being tested?
- Early Precut and Prolonged cannulation attempts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Dec 2013
- 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 85 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP.
Who cannot join
- active cholangitis or pancreatitis
- chronic pancreatitis,
- previous sphincterotomy,
- prior gastric surgery,
- coagulopathy,
- severe comorbidity (need for tracheal intubation)
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- patients who refused or were unable to give informed consent.
- patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD) (arbitrarily defined as "easy CBD cannulation"),
- detection of ampulloma or peri-papillary diverticula during ERCP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Precut Sphincterotomy During ERCP With Difficult Biliary Access (Italian: Esecuzione Del Pre-cut Precoce in Corso di ERCP Con Difficoltosa Incannulazione Della Via Biliare)
This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.
Read the detailed description
In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").
- Conditions
- Common Bile Duct Diseases
- Being tested
- Early Precut, Prolonged cannulation attempts
- Medical subject headings
- Common Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early PrecutProcedure or surgery
Early precut was performed during ERCP with difficult biliary cannulation
Prolonged cannulation attemptsProcedure or surgery
Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Early Precut Receives: Procedure: Early Precut |
| Group B | Active comparator | Prolonged cannulation attempts Receives: Procedure: Prolonged cannulation attempts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PEP
Measured: 24 hours
Secondary outcomes (1)
Incidence of overall complications
The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Interim analysis recommended terminating the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct DiseasesStudies 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
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- San Giuseppe Moscati Hospital, Istituti Ospitalieri di Cremona, Valduce Hospital, Papa Giovanni XXIII Hospital, Cardarelli Hospital, Azienda Ospedaliera Universitaria Senese, Maresca Hospital
- Responsible party
- Principal investigator, Testoni Pier Alberto, Università Vita-Salute San Raffaele
- Investigators
- Pier Alberto Testoni, Professor, Principal investigator, San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596646
- Sponsor's protocol ID
- PRECUT PRECOCE/01
- Status last verified
- Nov 2015
- First submitted
- 7 Sep 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Precut Sphincterotomy During ERCP With Difficult Biliary Access (Italian: Esecuzione Del Pre-cut Precoce in Corso di ERCP Con Difficoltosa Incannulazione Della Via Biliare)
- ClinicalTrials.gov ID
- NCT02596646
- Acronym / sponsor ID
- PRECUT PRECOCE/01
- Conditions
- Common Bile Duct Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis recommended terminating the study
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- San Giuseppe Moscati Hospital, Istituti Ospitalieri di Cremona, Valduce Hospital, Papa Giovanni XXIII Hospital, Cardarelli Hospital, Azienda Ospedaliera Universitaria Senese, Maresca Hospital
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Nov 2015 (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.
This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.
Detailed description
In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Early PrecutEarly Precut |
| Group B | Active comparator | Procedure: Prolonged cannulation attemptsProlonged cannulation attempts |
Who may qualify
- Ages
- 18 to 85 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP.
Key exclusion criteria (9 listed)
- active cholangitis or pancreatitis
- chronic pancreatitis,
- previous sphincterotomy,
- prior gastric surgery,
- coagulopathy,
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 |
|---|---|---|
| Early PrecutEarly precut was performed during ERCP with difficult biliary cannulation | Procedure or surgery | Group A |
| Prolonged cannulation attemptsProlonged cannulation attempts was performed during ERCP with difficult biliary cannulation | Procedure or surgery | Group B |
Primary outcome
Incidence of PEP
Time frame: 24 hours
1 secondary outcome
Incidence of overall complications
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Interim analysis recommended terminating the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
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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.
Pier Alberto Testoni, Professor principal investigator
San Raffaele 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 Early Precut and Prolonged cannulation attempts in people with Common Bile Duct Diseases, run by Università Vita-Salute San Raffaele 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Nov 2015. 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?
The study was stopped early (reason given: Interim analysis recommended terminating the 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?
Incidence of PEP (time frame: 24 hours). 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 6 Nov 2015; AzTrials last refreshed its copy on 28 Oct 2026.