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

Early versus delayed laparoscopic cholecystectomy in moderate and severe acute biliary pancreatitis: a randomised controlled trial - ELCAP

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055474

Enrollment

118

Registered

2023-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K851- Biliary acute pancreatitis Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Early Group: Laparoscopic cholecystectomy same admission cholecystectomy after resolution of acute pancreatitis Control Intervention1: Delayed Group: Laparoscopic cholecystectomy after

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria: 1.Age 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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
- Minor Surgical Complications ? Need for drainage procedure for peripancreatic fluid collection ? Total operating time ? Difficulty of the procedure ? Intra operative complications ? Cost of procedure ? Cost effectiveness ? Antibiotic use after surgery ? Patient satisfaction score ? Total length of hospital stay ? Need for readmission & interventionsTimepoint: Time of pancreatitis to time of surgery 1 week post surgery 3 week post surgery 3 month post surgery	—

Measure

Time frame

- Minor Surgical Complications ? Need for drainage procedure for peripancreatic fluid collection ? Total operating time ? Difficulty of the procedure ? Intra operative complications ? Cost of procedure ? Cost effectiveness ? Antibiotic use after surgery ? Patient satisfaction score ? Total length of hospital stay ? Need for readmission & interventionsTimepoint: Time of pancreatitis to time of surgery 1 week post surgery 3 week post surgery 3 month post surgery

—

Countries

India

Contacts

Public ContactProf Virinder Kumar Bansal

All India Institute of Medical Sciences, New Delhi

Drprajapatiom@gmail.com8003991303

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026