Study to evaluate ideal time for cholecystectomy after moderate and severe acute pancreatitis

Phase 2

Recruiting

Conditions: Biliary acute pancreatitis, (2) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2023/07/055474

Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Brief Summary: In patients with moderately severe and severe acute biliary

pancreatitis, the ideal timing of cholecystectomy which is the

definitive treatment to prevent further biliary complications is not

defined. Delaying cholecystectomy is associated with pancreatic-

biliary complications. In this study, we wish to define the ideal

timing of cholecystectomy in patients with moderate to severe acute

biliary pancreatitis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 118

Inclusion Criteria

Moderately severe or severe biliary AP diagnosed as per revised Atlanta classification 2.
Fit for surgery- A) anaesthetist the patient is fit for surgery B) Absence of large collection in right upper abdomen.

Exclusion Criteria

1.Age < 18 years or >70 years 2.Prior history of hepatobiliary surgery 3.American Society of Anesthesiology class III or more 4.Significant co-morbidity such as chronic kidney disease (CKD-V), Decompensated cirrhosis or congestive heart failure 6.Pregnancy 7.Refusal to give consen.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite outcome of major pancreatic-biliary events from the	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery
time of randomization to surgery or major cholecystectomy	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery
related complications i. e.	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery
A. By comparing the recurrence of acute pancreatitis, cholangitis,	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery
cholecystitis or	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery
conversion of laparoscopic to open procedure, hollow viscus	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery
injury, biliary injury or vascular injury	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery
other pancreatic-biliary events requiring any invasive intervention.	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery
B. By comparing the major surgical complications like	Time of pancreatitis to time of surgery \| 1 week post surgery \| 3 week post surgery \| 3 month post surgery

Secondary Outcome Measures

Name	Time	Method
- Minor Surgical Complications	âž¢ Need for drainage procedure for peripancreatic fluid collection

Trial Locations

Locations (1): All India Institute of Medical Sciences, New Delhi
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Harshit Gupta
Principal investigator
7791858673
HARSHIT30ROCKS@GMAIL.COM