Early Precut in Difficult Biliary Cannulation

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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Common Bile Duct Diseases

Intervention / Treatment
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* Procedure: Early Precut
* Procedure: Prolonged cannulation attempts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP. Exclusion Criteria: active cholangitis or pancreatitis chronic pancreatitis, previous sphincterotomy, prior gastric surgery, coagulopathy, severe comorbidity (need for tracheal intubation) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Early Precut | Procedure: Early Precut<br>* Early precut was performed during ERCP with difficult biliary cannulation<br>|
| Active Comparator: Group B<br>Prolonged cannulation attempts | Procedure: Prolonged cannulation attempts<br>* Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PEP |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of overall complications | The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol. | 24 hours |