Walled Off Pancreatic NecrosisNCT07395778
Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis
A study testing endoscopic ultrasonography guided cystogastrostomy in people with Walled Off Pancreatic Necrosis and Acute Pancreatitis (AP), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Walled Off Pancreatic Necrosis, Acute Pancreatitis (AP), Endoscopic Ultrasound-Guided Drainage
- What is being tested?
- endoscopic ultrasonography guided cystogastrostomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 18 Oct 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, 160012
Surinder Singh Rana, DM, +919560113930, drsurindersrana@gmail.com
Saurabh Kumar Singh, MD
About this study
Official title: 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
- 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
- Conditions
- Walled Off Pancreatic Necrosis, Acute Pancreatitis (AP), Endoscopic Ultrasound-Guided Drainage
- Being tested
- endoscopic ultrasonography guided cystogastrostomy
- Keywords
- Cystogastrostomy, Walled off pancreatic necrosis, nutrition
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasonography guided cystogastrostomyProcedure or surgery
Nasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization
| Study group | Role | What they receive |
|---|---|---|
| Nasojejunal feeding arm | Experimental | Not described Receives: Procedure: endoscopic ultrasonography guided cystogastrostomy |
| Oral feeding | Active comparator | Not described Receives: Procedure: endoscopic ultrasonography guided cystogastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional failure
To compare the rate of nutritional failure at Day 14 between Nasojejunal and oral feeding post endoscopic transmural drainage of WON
Measured: 14 days
Secondary outcomes (4)
Infection and new onset organ failure
To compare infection rates, need for antibiotic escalation and new onset organ failure
Measured: 14 days
Re-intervention needs
To compare the need for re-intervention and hospital stay duration in either of the group
Measured: 14 days
Change in weight
To compare patient weight
Measured: 14 days
Inflammatory markers
To compare change in inflammatory markers (CRP, Serum Albumin)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start18 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Walled Off Pancreatic NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saurabh Kumar Singh, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Surender Singh Rana, Professor, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395778
- Sponsor's protocol ID
- IEC-INT/2025/DM-3119
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07395778
- Acronym / sponsor ID
- IEC-INT/2025/DM-3119
- Conditions
- Walled Off Pancreatic Necrosis, Acute Pancreatitis (AP), Endoscopic Ultrasound-Guided Drainage
- Keywords
- Cystogastrostomy, Walled off pancreatic necrosis, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 18 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasojejunal feeding arm | Experimental | Procedure: endoscopic ultrasonography guided cystogastrostomy |
| Oral feeding | Active comparator | Procedure: endoscopic ultrasonography guided cystogastrostomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic ultrasonography guided cystogastrostomyNasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization | Procedure or surgery | Nasojejunal feeding arm, Oral feeding |
Primary outcome
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
4 secondary outcomes
Infection and new onset organ failure
Time frame: 14 days
Re-intervention needs
Time frame: 14 days
Change in weight
Time frame: 14 days
Inflammatory markers
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes
Related trials for Walled Off Pancreatic Necrosis
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Necrosectomy With Cryotechnology for Accelerated Removal
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Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis
Acute Necrotizing Pancreatitis
Not yet recruiting
Bedside Monitoring of Microenvironmental Changes in Infected Pancreatic Collections
Pancreatitis, Walled Off Pancreatic Necrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Surender Singh Rana, Professor principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ultrasonography guided cystogastrostomy in people with Walled Off Pancreatic Necrosis and Acute Pancreatitis (AP), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saurabh Kumar Singh (+919560113930, drsaurabhkrsingh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional failure (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.