Acute Pancreatitis (AP), Endoscopic Ultrasound-Guided Drainage, Walled Off Pancreatic Necrosis
Conditions
Keywords
Cystogastrostomy, Walled off pancreatic necrosis, nutrition
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
Interventions
PROCEDUREendoscopic ultrasonography guided cystogastrostomy
Nasojejunal tube will be placed post EUS-CG or oral diet would be started after randomization
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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
Exclusion criteria
1. Patients with collection not amenable for EUS guided drainage (distance of WON \>1 cm from the gastrointestinal lumen) 2. Known malignancy or immunocompromised state 3. Previous upper gastrointestinal(GI) surgery interfering with absorption 4. Active GI bleeding 5. GI obstruction, ileus or persistent vomiting 6. Patients moribund to undergo endoscopic procedure (Glasgow coma scale \<8 or patients on ventilatory support) 7. Patients with irreversible coagulopathy like platelets \<50,000/mm3 and/or INR\>1.5 8. Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional failure | 14 days | To compare the rate of nutritional failure at Day 14 between Nasojejunal and oral feeding post endoscopic transmural drainage of WON |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection and new onset organ failure | 14 days | To compare infection rates, need for antibiotic escalation and new onset organ failure |
| Re-intervention needs | 14 days | To compare the need for re-intervention and hospital stay duration in either of the group |
| Change in weight | 14 days | To compare patient weight |
| Inflammatory markers | 14 days | To compare change in inflammatory markers (CRP, Serum Albumin) |
Countries
India
Contacts
CONTACTSaurabh Kumar Singh
PRINCIPAL_INVESTIGATORSurender Singh Rana, Professor
Post Graduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed