NCT07395778
Recruiting
Not Applicable
Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis: A Randomized Controlled Pilot Study
Post Graduate Institute of Medical Education and Research, Chandigarh1 site in 1 country50 target enrollmentStarted: October 18, 2025Last updated:
Interventionsendoscopic ultrasonography guided cystogastrostomy
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Nutritional failure
Overview
Brief Summary
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
- whether nasojejunl feed is better than oral feed in patients undergoing endoscopic cystogastrostomy in walled off necrosis following acute pancreatitis
- How much infections they develop, whether they are able to tolerate the feed, weight gain and reintervention rates in each group
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of acute pancreatitis (AP) with 18-75 years of age
- •Patients with symptomatic WON requiring EUS guided transluminal drainage
- •Provision of written informed consent
Exclusion Criteria
- •Patients with collection not amenable for EUS guided drainage (distance of WON \>1 cm from the gastrointestinal lumen)
- •Known malignancy or immunocompromised state
- •Previous upper gastrointestinal(GI) surgery interfering with absorption
- •Active GI bleeding
- •GI obstruction, ileus or persistent vomiting
- •Patients moribund to undergo endoscopic procedure (Glasgow coma scale \<8 or patients on ventilatory support)
- •Patients with irreversible coagulopathy like platelets \<50,000/mm3 and/or INR\>1.5
- •Pregnant or lactating female
Arms & Interventions
Nasojejunal feeding arm
Experimental
Intervention: endoscopic ultrasonography guided cystogastrostomy (Procedure)
Oral feeding
Active Comparator
Intervention: endoscopic ultrasonography guided cystogastrostomy (Procedure)
Outcomes
Primary Outcomes
Nutritional failure
Time Frame: 14 days
To compare the rate of nutritional failure at Day 14 between Nasojejunal and oral feeding post endoscopic transmural drainage of WON
Secondary Outcomes
- Infection and new onset organ failure(14 days)
- Re-intervention needs(14 days)
- Change in weight(14 days)
- Inflammatory markers(14 days)
Investigators
Saurabh Kumar Singh
Senior Resident, Department of Gastroenterology
Post Graduate Institute of Medical Education and Research, Chandigarh
Study Sites (1)
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