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A study to compare Laparoscopic versus Endoscopic treatment For Acute Pancreatitis related fluid collection

A Prospective Randomized Trial Comparing Laparoscopic versus Endoscopic Drainage For Walled-off Necrosis Following Acute Pancreatitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018482
Enrollment
64
Registered
2019-04-08
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: K863- Pseudocyst of pancreas

Interventions

Intervention1: Laparoscopic Cystogastrostomy With Pancreatic Necrosectomy: Under General Anesthesia, With Laparoscope,The bulge of the WON on the posterior wall of the stomach will be identified. The

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient With The Following Inclusion Criteria Will Be Included In The Study 1. Symptoms In The Form Of Pain,Vomiting,Fever,Biliary Obstruction 2.Duration More Then Or Equal To 3 Weeks After An Attack Of Acute Pancreatitis With Or Without Infection 3.Size More Than Or Equal To 6cm In Diameter

Exclusion criteria

Exclusion criteria: 1. Patients with minimal fluid component in WON as seen in pre-intervention imaging (CT/MRI) 2. Patients who had undergone any form of intervention previously 3. Patients with WON located away from the stomach/duodenum 4.Patients with ASA grade III or more 5.Patients unfit for general anesthesia 6.Uncontrolled bleeding disorders 7.Patients not willing to be part of the study 8.Arterial pseudoaneurysm 9.Patient with obstructive jaundice with bilirubin more than or equal to 5mg/dl

Design outcomes

Primary

MeasureTime frame
The Primary Outcomes Will Be A Composite Of The Following Parameters :New Onset Organ Failure, Complications Such As Enteral Or Pancreatic- Cutaneous Fistula,Bleeding, Visceral perforation Requiring Interventions , Need For Additional Per Cutaneous Drainage And Mortality Following InterventionTimepoint: 3 Months After Intervention

Secondary

MeasureTime frame
â?¢Success Defined As Resolution Of WON By The Intended Modality At 3 Months â?¢Duration Of Hospital Stay. â?¢Recurrence Rates During A Follow Up Of 6 Months. â?¢Need Of Other Mode Of Drainage i.e. Laparoscopic Or Open Surgery In Endoscopic Group And Open Surgery Or Endoscopic Procedure In The Laparoscopic Group. â?¢Need For Additional Percutaneous Drainage â?¢Quality Of Life Index â?¢Cost- effectiveness Timepoint: Success By Intended Modality At 3 Months Recurrence Rated During Follow Up Of 6 Months Need Of Additional Percutaneous Drainage Or Other Mode Of Drainage At 6 Months

Countries

India

Contacts

Public ContactDr Saharsh Ambade

All India Institute of Medical Sciences

drvkbansal@gmail.com91-11-26593686

Outcome results

None listed

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