Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • endoscopic ultrasonography guided cystogastrostomy

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Nasojejunal feeding armExperimental treatment 1 intervention
Group B: Oral feedingActive comparator 1 intervention

Trial outcomes

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

Time frame
14 days

Secondary outcomes

1

Infection and new onset organ failure

To compare infection rates, need for antibiotic escalation and new onset organ failure

Time frame
14 days
2

Re-intervention needs

To compare the need for re-intervention and hospital stay duration in either of the group

Time frame
14 days
3

Change in weight

To compare patient weight

Time frame
14 days
4

Inflammatory markers

To compare change in inflammatory markers (CRP, Serum Albumin)

Time frame
14 days

Other outcomes

Sponsors and contacts

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