CompletedNot Applicable

Cholecystectomy TIming for Mild Acute Biliary Pancreatitis [CTIMAP]: a Società Lombarda di Chirurgia Observational Study

Italy445 participantsStarted 2022-04-12

Plain-language summary

CTIMAP is a prospective multicenter observational study on patients with Mild Acute Biliary Pancreatitis (MABP) treated with Same Admission Cholecystectomy (SAC) and Interval Cholecystectomy (IC). The rationale of this study is to investigate the timing of cholecystectomy after MABP applied by Lombard surgeons and compare SAC and IC, with the hypothesis that SAC would reduce the risk of recurrent Gallstones Related Events (GRE) without increasing the difficulty of surgery and postoperative complications.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * to be admitted with a diagnosis of acute pancreatitis, as defined according to 2012 Atlanta Criteria * pancreatitis is mild as defined according to 2012 Atlanta Criteria * the etiology of pancreatitis is a gallstone related (finding of stones or sludge in the gallbladder on in the main biliary duct) * be greater than or equal to 18 years old * provide signed and dated informed consent form * willing to comply with all study procedures and be available during the study Exclusion Criteria: * pregnancy or lactation * pancreatitis not related to a gallstone etiology * chronic pancreatitis * moderately severe or severe pancreatitis * alcohol abuse * anything that would place the individual at increased risk or prevent the individual's full compliance with or completion of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of 6-month readmission due to GRE after hospitalization for MABP

Timeframe: 6 months

Trial details

NCT IDNCT07234136

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Mild Acute Biliary Pancreatitis trials