| CTRI Number |
CTRI/2026/01/101964 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Tube Feeding and Oral Feeding After Endoscopic Drainage of Pancreatic Necrosis |
|
Scientific Title of Study
|
Nasojejunal feeding versus oral feeding following endoscopic drainage of walled off pancreatic necrosis: A Randomized controlled pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surinder Singh Rana |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Depatment of Gastroenterology, Sector-12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872199135 |
| Fax |
|
| Email |
drsurindersrana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder Singh Rana |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Depatment of Gastroenterology, Sector-12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872199135 |
| Fax |
|
| Email |
drsurindersrana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Kumar Singh |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Depatment of Gastroenterology, Sector 12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560113930 |
| Fax |
|
| Email |
drsaurabhkrsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER, Sector-12, Chandigarh, India-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Kumar Singh |
PGIMER Chandigarh |
Room no 4, Department of Gatroenterology, F block, Nehru Hospital, PGIMER, Sector-12, Chandigarh-160012
Chandigarh
CHANDIGARH |
9560113930
drsaurabhkrsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasojejunal feeding |
Nasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization for 14 days |
| Comparator Agent |
Oral feeding |
Nasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rate of nutritional failure at Day 14 between Nasojejunal and oral feeding post endoscopic transmural drainage of WON |
at baseline, Day 1, Day 2, Day 5 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Infection and new onset organ failure |
14 days |
| Re-intervention needs |
14 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsaurabhkrsingh@gmail.com].
- For how long will this data be available start date provided 28-01-2026 and end date provided 31-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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. 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 |