Effect of Proton Pump Inhibitor on need for Necrosectomy in patients with necrotizing pancreatitis having a symptomatic walled off necrosis.

Effect of Proton Pump Inhibitor in patients undergoing Endoscopic Ultrasound guided transluminal drainage of Walled Off Necrosis : A randomised controlled trial - PAUSE-WON

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108067

Enrollment

Registered

2026-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K85- Acute pancreatitis

Interventions

Intervention1: Proton Pump Inhibitor (PPI) group: After successful endoscopic ultrasound guided transmural draiange of walled-off-necrosis, in PPI group, twice a day PPI ( 40 mg/d omeprazole, 40 mg/d

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic WON amenable for EUS guided transluminal drainage

Exclusion criteria

Exclusion criteria: 1. Patients with prior peptic ulcer disease or any bleeding diathesis 2. Collection is not amenable for EUS guided drainage 3. Patients moribund to undergo endoscopic procedure (Glasglow coma scale less than 8 or patients on ventilatory support) 4. Patients with underlying calcific pancreatitis 5. Patients with prior history of intervention (endoscopic/percutaneous/surgical) in the necrotic collection 6. Patients with irreversible coagulopathy like platelets less than 50,000/mm3 and/or INR more than 1.5 7. Pregnant female

Design outcomes

Primary

Measure	Time frame
Number of direct endoscopic necrosectomy sessions required after index drainage procedure to achieve clinical successTimepoint: 3 months post-index drainage	—

Secondary

Measure	Time frame
Incidence of stent occlusion till clinical successTimepoint: 3 months post-index drainage;Incidence of significant bleeding (Hb drop more than 2gm/dl or new onset hemodynamic instability or requirement of any intervention for haemostasis)Timepoint: 3 months post-index drainage;Procedure related complications as per ASGE- Lexicon guidelinesTimepoint: 3 months post-index drainage;Re-admission ratesTimepoint: 3 months post-index drainage;Total hospitalisation daysTimepoint: 3 months post-index drainage;Mortality due to basic disease and all complicationsTimepoint: 3 months post-index drainage	—

Measure

Time frame

Incidence of stent occlusion till clinical successTimepoint: 3 months post-index drainage;Incidence of significant bleeding (Hb drop more than 2gm/dl or new onset hemodynamic instability or requirement of any intervention for haemostasis)Timepoint: 3 months post-index drainage;Procedure related complications as per ASGE- Lexicon guidelinesTimepoint: 3 months post-index drainage;Re-admission ratesTimepoint: 3 months post-index drainage;Total hospitalisation daysTimepoint: 3 months post-index drainage;Mortality due to basic disease and all complicationsTimepoint: 3 months post-index drainage

—

Countries

India

Contacts

Public ContactDr Jimil Shah

Postgraduate Institute of Medical Education and Research

shahjimil22@gmail.com8655376773

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026