Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis

Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis: A Randomized Controlled Pilot Study

The goal of this randomized control trial is to assess whether nasojejunal feed is better than oral nutrition in patients who are undergoing endoscopic cystogastrostomy of walled off necrosis following acute pancreatitis. It will also try to answer, the incidence of infections and feed tolerance.

The main question it tries to answer is

1. whether nasojejunl feed is better than oral feed in patients undergoing endoscopic cystogastrostomy in walled off necrosis following acute pancreatitis
2. How much infections they develop, whether they are able to tolerate the feed, weight gain and reintervention rates in each group

Study Overview

• Status: Recruiting
• Conditions: Walled Off Pancreatic Necrosis; Acute Pancreatitis (AP); Endoscopic Ultrasound-Guided Drainage
• Intervention / Treatment: Procedure: endoscopic ultrasonography guided cystogastrostomy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saurabh Kumar Singh; Phone Number: +919560113930; Email: drsaurabhkrsingh@gmail.com

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Post Graduate Institute of Medical Education and Research (PGIMER)
    • Contact: Surinder Singh Rana, DM; Phone Number: +919560113930; Email: drsurindersrana@gmail.com
    • Principal Investigator: Saurabh Kumar Singh, MD
    • Principal Investigator: Surinder Singh Rana, DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients of acute pancreatitis (AP) with 18-75 years of age
2. Patients with symptomatic WON requiring EUS guided transluminal drainage
3. Provision of written informed consent

Exclusion Criteria:

1. Patients with collection not amenable for EUS guided drainage (distance of WON >1 cm from the gastrointestinal lumen)
2. Known malignancy or immunocompromised state
3. Previous upper gastrointestinal(GI) surgery interfering with absorption
4. Active GI bleeding
5. GI obstruction, ileus or persistent vomiting
6. Patients moribund to undergo endoscopic procedure (Glasgow coma scale <8 or patients on ventilatory support)
7. Patients with irreversible coagulopathy like platelets <50,000/mm3 and/or INR>1.5
8. Pregnant or lactating female

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasojejunal feeding arm	Procedure: endoscopic ultrasonography guided cystogastrostomy; Nasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization
Active Comparator: Oral feeding	Procedure: endoscopic ultrasonography guided cystogastrostomy; Nasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional failure	To compare the rate of nutritional failure at Day 14 between Nasojejunal and oral feeding post endoscopic transmural drainage of WON	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection and new onset organ failure	To compare infection rates, need for antibiotic escalation and new onset organ failure	14 days
Re-intervention needs	To compare the need for re-intervention and hospital stay duration in either of the group	14 days
Change in weight	To compare patient weight	14 days
Inflammatory markers	To compare change in inflammatory markers (CRP, Serum Albumin)	14 days

Collaborators and Investigators

• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
• Investigators: Principal Investigator: Surender Singh Rana, Professor, Post Graduate Institute of Medical Education and Research, Chandigarh

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cystogastrostomy, Walled off pancreatic necrosis, nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: IEC-INT/2025/DM-3119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After 1 year
• IPD Sharing Access Criteria: Who wants to publish individual data meta-analysis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No