NCT07395778

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

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Oct 2025Jan 2027

Study Start

First participant enrolled

October 18, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

November 18, 2025

Last Update Submit

January 31, 2026

Conditions

Walled Off Pancreatic NecrosisAcute Pancreatitis (AP)Endoscopic Ultrasound-Guided Drainage

Keywords

Cystogastrostomy, Walled off pancreatic necrosis, nutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Infection and new onset organ failure

    14 days

  • Re-intervention needs

    14 days

  • Change in weight

    14 days

  • Inflammatory markers

    14 days

Study Arms (2)

Nasojejunal feeding arm

EXPERIMENTAL
Procedure: endoscopic ultrasonography guided cystogastrostomy

Oral feeding

ACTIVE COMPARATOR
Procedure: endoscopic ultrasonography guided cystogastrostomy

Interventions

endoscopic ultrasonography guided cystogastrostomyPROCEDURE

Nasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization

Nasojejunal feeding armOral feeding

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Surender Singh Rana, Professor

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saurabh Kumar Singh

CONTACT

+919560113930drsaurabhkrsingh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Resident, Department of Gastroenterology

Study Record Dates

First Submitted

November 18, 2025

First Posted

February 9, 2026

Study Start

October 18, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After 1 year
Access Criteria
Who wants to publish individual data meta-analysis

Locations

IN(1)