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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasojejunal feeding arm | Experimental |
| |
| Oral feeding | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic ultrasonography guided cystogastrostomy | Procedure | Nasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saurabh Kumar Singh | Contact | +919560113930 | drsaurabhkrsingh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Surender Singh Rana, Professor | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Medical Education and Research (PGIMER) | Recruiting | Chandigarh | 160012 | India |
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After 1 year
Who wants to publish individual data meta-analysis
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol | Jun 17, 2025 |
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| 14 days |
| Change in weight | To compare patient weight | 14 days |
| Inflammatory markers | To compare change in inflammatory markers (CRP, Serum Albumin) | 14 days |
| Jan 17, 2026 |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2025 | Jan 31, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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