Cholecystectomy TIming for Mild Acute Biliary Pancreatiti... | NCT07234136

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

NCT07234136

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Completed

Last Update Posted

Nov 18, 2025Actual

Enrollment

445Actual

Phase

Not provided

Conditions

Mild Acute Biliary Pancreatitis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2022Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Nov 14, 2025

First Submission Date that Met QC Criteria

Nov 14, 2025

First Posted Date

Nov 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcello Maestri, MD, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

445Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Mild Acute Biliary Pancreatitis treated with the Same Admission Cholecystectomy
Patients with Mild Acute Biliary Pancreatitis treated with Interval Cholecystectomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
30-day postoperative complications rate after SAC and after IC in patients with MABP		Day 30
30-day postoperative biliary complications rate after SAC and after IC in patients with MABP		Day 30

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with MABP treated with SAC or IC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Policlinico San Matteo		Pavia	Pavia	27100	Italy