Mild Acute Biliary PancreatitisCTIMAPNCT07234136
Cholecystectomy TIming for Mild Acute Biliary Pancreatitis [CTIMAP]: a Società Lombarda di Chirurgia Observational Study
An observational study of Mild Acute Biliary Pancreatitis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Acute Biliary Pancreatitis
- How many people
- 445 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with MABP treated with SAC or IC
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mild Acute Biliary Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Mild Acute Biliary Pancreatitis treated with the Same Admission Cholecystectomy | Not described | |
| Patients with Mild Acute Biliary Pancreatitis treated with Interval Cholecystectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of 6-month readmission due to GRE after hospitalization for MABP
Measured: 6 months
Secondary outcomes (10)
30-day postoperative complications rate after SAC and after IC in patients with MABP
Measured: Day 30
30-day postoperative biliary complications rate after SAC and after IC in patients with MABP
Measured: Day 30
30-day postoperative mortality rate after SAC and after IC in patients with MABP
Measured: Day 30
Intraoperative complication rate during SAC and IC
Measured: Day of SAC or IC
Rate of bail out procedures during SAC and IC
Measured: Day of SAC or IC
Conversion to open laparotomy rate during SAC and during IC in patients with MABP
Measured: Day of SAC or IC
Operative times (minutes) of SAC and of IC in patients with MABP
Measured: Day of SAC or IC
Postoperative length of stay (PO-LOS) after SAC and after IC in patients with MABP
Measured: At discharge
Total length of stay (T-LOS) of patients with MABP treated with SAC and with IC
Measured: At discharge
Rate of patients who after six months after discharge did not receive cholecystectomy (no-cholecystectomy group)
Measured: 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start12 Apr 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Acute Biliary PancreatitisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Maestri, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234136
- Sponsor's protocol ID
- CTIMAP
- Acronym
- CTIMAP
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecystectomy TIming for Mild Acute Biliary Pancreatitis [CTIMAP]: a Società Lombarda di Chirurgia Observational Study
- ClinicalTrials.gov ID
- NCT07234136
- Acronym / sponsor ID
- CTIMAP / CTIMAP
- Conditions
- Mild Acute Biliary Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Mild Acute Biliary Pancreatitis treated with the Same Admission Cholecystectomy | – | – |
| Patients with Mild Acute Biliary Pancreatitis treated with Interval Cholecystectomy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MABP treated with SAC or IC
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- pregnancy or lactation
- pancreatitis not related to a gallstone etiology
- chronic pancreatitis
- moderately severe or severe pancreatitis
- alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of 6-month readmission due to GRE after hospitalization for MABP
Time frame: 6 months
10 secondary outcomes
30-day postoperative complications rate after SAC and after IC in patients with MABP
Time frame: Day 30
30-day postoperative biliary complications rate after SAC and after IC in patients with MABP
Time frame: Day 30
30-day postoperative mortality rate after SAC and after IC in patients with MABP
Time frame: Day 30
Intraoperative complication rate during SAC and IC
Time frame: Day of SAC or IC
Rate of bail out procedures during SAC and IC
Time frame: 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
Operative times (minutes) of SAC and of IC in patients with MABP
Time frame: Day of SAC or IC
Postoperative length of stay (PO-LOS) after SAC and after IC in patients with MABP
Time frame: At discharge
Total length of stay (T-LOS) of patients with MABP treated with SAC and with IC
Time frame: At discharge
Rate of patients who after six months after discharge did not receive cholecystectomy (no-cholecystectomy group)
Time frame: 6 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Related trials for Mild Acute Biliary Pancreatitis
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Outpatient Versus Inpatient Management of Mild Acute Pancreatitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Acute Biliary Pancreatitis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of 6-month readmission due to GRE after hospitalization for MABP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.