Mild Acute Biliary Pancreatitis
Conditions
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.
Interventions
None listed
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of 6-month readmission due to GRE after hospitalization for MABP | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 30-day postoperative biliary complications rate after SAC and after IC in patients with MABP | Day 30 |
| 30-day postoperative mortality rate after SAC and after IC in patients with MABP | Day 30 |
| Intraoperative complication rate during SAC and IC | Day of SAC or IC |
| Rate of bail out procedures during SAC and IC | Day of SAC or IC |
| 30-day postoperative complications rate after SAC and after IC in patients with MABP | Day 30 |
| Operative times (minutes) of SAC and of IC in patients with MABP | Day of SAC or IC |
| Postoperative length of stay (PO-LOS) after SAC and after IC in patients with MABP | At discharge |
| Total length of stay (T-LOS) of patients with MABP treated with SAC and with IC | At discharge |
| Rate of patients who after six months after discharge did not receive cholecystectomy (no-cholecystectomy group) | 6 months after discharge |
| Conversion to open laparotomy rate during SAC and during IC in patients with MABP | Day of SAC or IC |
Countries
Italy
Outcome results
None listed