A comparison of early versus delayed surgery to remove gall bladder in patients with moderately severe and severe gallstone induced pancreatitis.

Early Versus Delayed Laparoscopic Cholecystectomy in Moderate and Severe Acute Biliary Pancreatitis: A Randomised Controlled trial - ELCAP trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030746

Enrollment

118

Registered

2021-01-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Early Cholecystectomy: Cholecystectomy within 2 weeks of discharge after an attack of acute biliary pancreatitis Control Intervention1: Delayed Cholecystectomy: Cholecystectomy done 6-8

Eligibility

Inclusion criteria

Inclusion criteria: 1 Moderately severe or severe acute biliary pancreatitis diagnosed as per revised Atlanta classification 2 Fit for surgery

Exclusion criteria

Exclusion criteria: 1.Age 70 years 2.Prior history of hepatobiliary surgery 3.American Society of Anaesthesiology class III or more 4.Significant co-morbidity such as chronic kidney disease (CKD-V), Decompensated cirrhosis or congestive heart failure 5.Patient unfit for surgery 6.Pregnancy 7.Refusal to give consent

Design outcomes

Primary

Measure	Time frame
Primary outcome: A composite outcome consisting of major pancreatobiliary events from the time of randomisation to surgery. 1.Recurrence of AP based on clinical, biochemical, and imaging criteria 2.Acute cholecystitis: defined according to Tokyo Guidelines 3.Acute cholangitis: defined according to Tokyo guidelines 4.Any other pancreatobiliary event requiring endoscopic or radiologic intervention such as Endoscopic retrograde Cholangiography Timepoint: 6 months	—

Measure

Time frame

Primary outcome: A composite outcome consisting of major pancreatobiliary events from the time of randomisation to surgery. 1.Recurrence of AP based on clinical, biochemical, and imaging criteria 2.Acute cholecystitis: defined according to Tokyo Guidelines 3.Acute cholangitis: defined according to Tokyo guidelines 4.Any other pancreatobiliary event requiring endoscopic or radiologic intervention such as Endoscopic retrograde Cholangiography Timepoint: 6 months

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Secondary

Measure	Time frame
Secondary outcome 1.Complications 2.Need for drainage procedure of pancreatic collections prior to surgery 3.Conversion of laparoscopic cholecystectomy to open cholecystectomy 4.Total operating time defined as the time taken from skin incision to skin closure. 5.Difficulty of the procedure 6.Cost of procedure: 7.Cost effectiveness: 8.Antibiotic use after laparoscopic cholecystectomy 9.Patient satisfaction score 10 Hospital stay: 11N eed for readmission and interventions Timepoint: 6 months	—

Measure

Time frame

Secondary outcome 1.Complications 2.Need for drainage procedure of pancreatic collections prior to surgery 3.Conversion of laparoscopic cholecystectomy to open cholecystectomy 4.Total operating time defined as the time taken from skin incision to skin closure. 5.Difficulty of the procedure 6.Cost of procedure: 7.Cost effectiveness: 8.Antibiotic use after laparoscopic cholecystectomy 9.Patient satisfaction score 10 Hospital stay: 11N eed for readmission and interventions Timepoint: 6 months

—

Countries

India

Contacts

Public ContactPrasanth J

All India Institute of Medical Sciences

drvkbansal@gmail.com9810348479

Outcome results

None listed

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