Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery (PROSECCO)

April 27, 2026 updated by: Semmelweis University

Prophylactic Endoscopic Sphincterotomy in Patients Unfit for Cholecystectomy After an Acute Biliary Pancreatitis Episode - an Open-label, Two-armed, Randomized Controlled Trial

This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of prophylactic endoscopic sphincterotomy (ES) in frail patients unfit for cholecystectomy following an episode of acute biliary pancreatitis (ABP).

Eligible patients will be randomized in a 1:1 ratio to either prophylactic ES during the index admission or conservative treatment. The primary endpoint is the time from randomization to the first occurrence of a recurrent pancreatobiliary event within 12 months, including recurrent ABP, cholangitis, choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP), or cholangiogenic liver abscess. Secondary outcomes include mortality, pancreatobiliary events requiring intensive care unit admission, post-ERCP complications, cholecystitis, and length of hospitalization.

A total of 92 patients will be enrolled. The trial will be led by the Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary, and conducted in accordance with Good Clinical Practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. adult patients (above 18 years)
  2. naïve papilla

  3. evidence of AP based on the Atlanta criteria:

    • pain in the upper abdomen
    • serum amylase or lipase concentration > 3 times the upper limit of normal
    • imaging features of acute pancreatitis on abdominal imaging

  4. high probability of a biliary etiology:

    • gallstones or biliary sludge on imaging (any type)
    • dilated common bile duct on imaging defined as > 8 mm in patients ≤ 75 years or > 10 mm in patients > 75 years
    • abnormal liver enzymes (alanine aminotransferase [ALT] two times the upper limit of normal)
  5. patients unfit for surgery due to the attending physician's decision e.g. American Society of Anesthesiologists (ASA) class ≥ III; severe heart failure with reduced ejection fraction <40%, severe uncontrolled hypertension, chronic kidney disease stage four or five

Exclusion Criteria:

  1. previous cholecystectomy
  2. previous endoscopic sphincterotomy or pancreatobiliary stenting

  3. ERCP/ES is recommended by the guidelines (3)

    • sign of cholangitis
    • presence of CBD stone on any imaging
    • signs of stone in endoscopic ultrasonography or magnetic resonance imaging in case of abnormal liver enzymes (persistently elevated ALT and aspartate aminotransferase (AST) with less than a 20% decrease over four days) or dilated CBD (defined as above)
  4. chronic pancreatitis
  5. estimated life expectancy < 12 months
  6. ERCP is contraindicated, e.g. the procedure cannot be carried out safely due to the patient's comorbidities or physical status; high risk of bleeding or contraindication of the discontinuation of the anticoagulation therapy.
  7. ERCP is technically not feasible due to altered anatomy, e.g., total gastrectomy, Roux-en-Y gastric bypass anatomy
  8. pancreatobiliary malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prophylactic endoscopic sphincterotomy

Papillary cannulation and sphincterotomy techniques will be performed in adherence to the recommendations outlined in the ESGE (European Society of Gastrointestinal Endoscopy) guideline. All recommended measures for post-ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis prevention must be implemented, including the use of prophylactic pancreatic stents, rectal nonsteroidal anti-inflammatory drugs, and optimal hydration protocols where appropriate.

All rescue techniques may be utilized if necessary, in accordance with clinical judgment and guideline recommendations.

ERCP/ES (endoscopic sphincterotomy) will be performed by an experienced endoscopist, defined as someone who has performed more than 300 ERCPs in their lifetime and maintains a native papilla cannulation success rate of at least 90%.

If the ES cannot be performed during the initial ERCP, the number of further attempts is under the discretion of the endoscopist.
Procedure: Prophylactic endoscopic sphincterotomy
Participants in this arm will undergo prophylactic endoscopic sphincterotomy performed by experienced endoscopists, with all recommended preventive measures against post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) applied according to international guidelines.
No Intervention: Conservative treatment
This study arm will follow a conservative treatment strategy, and no endoscopic procedures will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent pancreatobiliary events
Time Frame: 1 year

Composite time-to-first-event endpoint including:

  • cholangitis - Tokyo guidelines
  • recurrent acute biliary pancreatitis - revised Atlanta criteria
  • choledocholithiasis - imaging/ERCP confirmation
  • cholangiogenic liver abscess - imaging plus clinical diagnosis
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, or cholangiogenic liver abscess (individual components of the composite primary outcome)
Time Frame: At 3, 6, 9, and 12 months.
Each component event will be reported separately as the number of participants experiencing the event during follow-up. Definitions: recurrent acute biliary pancreatitis (revised Atlanta criteria), cholangitis (Tokyo guidelines), choledocholithiasis (imaging/ERCP-confirmed bile duct stone), cholangiogenic liver abscess (imaging and clinical diagnosis).
At 3, 6, 9, and 12 months.
Length of hospitalization
Time Frame: From enrollment to one month.
The number of days from hospital admission until discharge, as determined by the treating physician based on clinical stability and institutional criteria. Results will be reported as days of hospitalization per participant, summarized using descriptive statistics (mean, median, interquartile range and standard deviation).
From enrollment to one month.
Pancreatobiliary events requiring intensive care unit admission
Time Frame: At 3, 6, 9, and 12 months.
Number of pancreatobiliary events (recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, cholangiogenic liver abscess) resulting in intensive care unit admission. Events will be defined according to standard criteria (revised Atlanta criteria for pancreatitis, Tokyo guidelines for cholangitis, imaging/ERCP confirmation for choledocholithiasis, and imaging plus clinical diagnosis for liver abscess).
At 3, 6, 9, and 12 months.
Mortality associated with pancreatobiliary events
Time Frame: At 3, 6, 9, and 12 months.
Deaths directly attributable to pancreatobiliary events (recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, cholangiogenic liver abscess), adjudicated by the study committee. Events will be defined according to standard criteria (revised Atlanta criteria for pancreatitis, Tokyo guidelines for cholangitis, imaging/ERCP confirmation for choledocholithiasis, and imaging plus clinical diagnosis for liver abscess).
At 3, 6, 9, and 12 months.
All-cause mortality
Time Frame: At 3, 6, 9, and 12 months.
Death from any cause during follow-up.
At 3, 6, 9, and 12 months.
Acute cholecystitis
Time Frame: At 3, 6, 9, and 12 months.
Incidence of acute cholecystitis (Tokyo Guidelines).
At 3, 6, 9, and 12 months.
Post-endoscopic retrograde cholangiopancreatography pancreatitis
Time Frame: Peri-procedural.
Incidence of pancreatitis (revised Atlanta-criteria) following endoscopic retrograde cholangiopancreatography, with focus on moderate and severe cases
Peri-procedural.
Other endoscopic retrograde cholangiopancreatography-related complications
Time Frame: Peri-procedural.

Incidence of adverse events related to endoscopic retrograde cholangiopancreatography, including bleeding, cholangitis, and perforation.

Complications will be defined according to clinical, laboratory, endoscopic, and imaging findings, and classified by severity based on the need for intervention, hospitalization, or prolonged recovery.
Peri-procedural.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NNGYK/34436-6/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be available upon reasonable request to the study investigators after publication.

IPD Sharing Time Frame

It will be available from 6 months after publication of the primary results and will remain available for at least 5 years thereafter.

IPD Sharing Access Criteria

Researchers with a methodologically sound proposal may request access to the de-identified IPD. Requests should be submitted to the corresponding author. Data will be shared after approval of the request and signing a data-sharing agreement, through secure institutional data transfer.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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