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

November 14, 2025 updated by: Marcello Maestri, Fondazione IRCCS Policlinico San Matteo di Pavia
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

445

Contacts and Locations

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

Study Locations

  • Italy
    • Pavia
      • Pavia, Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo

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

Sampling Method

Non-Probability Sample

Study Population

Patients with MABP treated with SAC or IC

Description

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.

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

Cohorts and Interventions

Group / Cohort
Patients with Mild Acute Biliary Pancreatitis treated with the Same Admission Cholecystectomy
Patients with Mild Acute Biliary Pancreatitis treated with Interval Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of 6-month readmission due to GRE after hospitalization for MABP
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day postoperative complications rate after SAC and after IC in patients with MABP
Time Frame: Day 30
Day 30
30-day postoperative biliary complications rate after SAC and after IC in patients with MABP
Time Frame: Day 30
Day 30
30-day postoperative mortality rate after SAC and after IC in patients with MABP
Time Frame: Day 30
Day 30
Intraoperative complication rate during SAC and IC
Time Frame: Day of SAC or IC
Day of SAC or IC
Rate of bail out procedures during SAC and IC
Time Frame: Day of SAC or IC
Day of SAC or IC
Conversion to open laparotomy rate during SAC and during IC in patients with MABP
Time Frame: Day of SAC or IC
Day of SAC or IC
Operative times (minutes) of SAC and of IC in patients with MABP
Time Frame: Day of SAC or IC
Day of SAC or IC
Postoperative length of stay (PO-LOS) after SAC and after IC in patients with MABP
Time Frame: At discharge
At discharge
Total length of stay (T-LOS) of patients with MABP treated with SAC and with IC
Time Frame: At discharge
At discharge
Rate of patients who after six months after discharge did not receive cholecystectomy (no-cholecystectomy group)
Time Frame: 6 months after discharge
6 months after discharge

Collaborators and Investigators

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

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

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 (Actual)

April 12, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CTIMAP

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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