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

Fondazione IRCCS Policlinico San Matteo di Pavia445 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

445

Conditions

Mild Acute Biliary Pancreatitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

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

Time frame: 6 months

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