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Early versus delayed gall stone removal surgery in moderately severe and severe pancreatitis cases

Early Versus Delayed Laparoscopic Cholecystectomy in Moderately Severe and Severe Acute Biliary Pancreatitis : A Randomised Controlled Trial - NILL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094352
Enrollment
118
Registered
2025-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Interventions

Intervention1: Early Cholecystectomy: Early Laparoscopic Cholecystectomy immediately after the resolution of Severe and Moderately Severe acute pancreatitis episode Control Intervention1: Delayed Chol

Sponsors

Priti Ranjan Rout
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Moderately severe and Severe Acute biliary pancreatitis as per revised atlanta classification 2. Fit for surgery as per anaesthesia and absence of large collection in right upper quadrant of abdomen

Exclusion criteria

Exclusion criteria: 1. Prior history of hepatobiliary surgery 2. ASA III or more 3. Significant comorbidity - CKD, Congestive heart failure or decompensated cirrhosis 4. Pregnancy 5. Refusal to give consent

Design outcomes

Primary

MeasureTime frame
Recurrence of Acute Pancreatitis/ new onset Acute Cholecystitis/ Cholangitis or any other pancreatico biliary event requiring invasive interventionTimepoint: from date of randomisation to 1week, 3 week and 3 months after surgery—

Secondary

MeasureTime frame
Minor surgical complication according to clavien dindo classification & comprehensive complication indexTimepoint: Day of surgery to 1week, 3 week & 3 months postoperative period;Need for drainage procedure of peripancreatic fluid collection prior to surgeryTimepoint: From randomisation to date of surgery;total operating timeTimepoint: skin incision to skin closure;Post operative hospital stayTimepoint: From day of surgery to 3 months;Need for readmission or interventionTimepoint: From randomisation to 3 months;Difficulty of the procedure as assessed by the surgeonTimepoint: Intraoperative—

Countries

India

Contacts

Public ContactDr Rajinder Parshad

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

rajinderparshad@aiims.edu9868397715

Outcome results

None listed

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