| CTRI Number |
CTRI/2026/04/108067 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effect of proton pump inhibitor on need of necrosectomy ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Proton Pump Inhibitor on need for Necrosectomy in patients with necrotizing pancreatitis having a symptomatic walled off necrosis. |
|
Scientific Title of Study
|
Effect of Proton Pump Inhibitor in patients undergoing Endoscopic Ultrasound guided transluminal drainage of Walled Off Necrosis : A randomised controlled trial |
| Trial Acronym |
PAUSE-WON |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jimil Shah |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology,
Nehru Hospital,
Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
8655376773 |
| Fax |
|
| Email |
shahjimil22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jimil Shah |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology,
Nehru Hospital,
Chandigarh
CHANDIGARH 160012 India |
| Phone |
8655376773 |
| Fax |
|
| Email |
shahjimil22@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jimil Shah |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology,
Nehru Hospital,
Chandigarh
CHANDIGARH 160012 India |
| Phone |
8655376773 |
| Fax |
|
| Email |
shahjimil22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research (PGIMER) as providing Infrastructure support |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 |
| Jimil Shah |
Postgraduate Institute of Medical Education and Research |
Department of Gastroenterology, Nehru Hospital Chandigarh CHANDIGARH |
08655376773
shahjimil22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K85||Acute pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-PPI (proton pump inhibitor) group |
After successful endoscopic ultrasound guided transmural draiange of walled-off-necrosis, in non-PPI group, patients will be kept on conservative treatment without any PPI. Patients in this group will be given PPI only in case of development of stress ulcer, or bleeding or significant gastric discomfort. All utilization of PPI during hospitalization or till clinical success will be recorded. |
| Intervention |
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 esomeprazole, 80 mg/d pantoprazole, and 40 mg/d rabeprazole will be defined as equivalent dosages) will be given. The same dose will be continued till clinical success is achieved. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with symptomatic WON amenable for EUS guided transluminal drainage
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of direct endoscopic necrosectomy sessions required after index drainage procedure to achieve clinical success |
3 months post-index drainage |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of stent occlusion till clinical success |
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) |
3 months post-index drainage |
| Procedure related complications as per ASGE- Lexicon guidelines |
3 months post-index drainage |
| Re-admission rates |
3 months post-index drainage |
| Total hospitalisation days |
3 months post-index drainage |
| Mortality due to basic disease and all complications |
3 months post-index drainage |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/04/2026 |
| 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 - NO
|
|
Brief Summary
|
Acute Pancreatitis(AP) is one of the most common gastrointestinal cause for hospital admissions. The spectrum of AP ranges from interstitial pancreatitis to necrotising pancreatitis. The severity of AP is classified into mild, moderately severe and severe based on local complications and organ failure. The organ failure is classified based on the modified Marshall Scoring system. Necrotising pancreatitis is seen in around 10-15% of patients with AP, the necrosis can involve the pancreatic parenchyma(<5%), the peripancreatic tissue(20%) or both (75-80%). The revised Atlanta classification has classified the pancreatic fluid collection into four categories based on the duration after onset of pancreatitis, the content of collection (liquid vs presence of solid debris) and presence or absence of encapsulating wall. The four categories are -Acute peripancreatic fluid collection, Acute necrotic collection, pseudocyst and Walled Off Necrosis(WON) . It is important to differentiate necrotic collection from other fluid collections. Magnetic resonance imaging(MRI) or Ultrasound is better modality than contrast enhanced computed tomography (CECT) to differentiate the same. WON (walled-off necrosis) is defined as a mature, encapsulated collection of pancreatic and/or peripancreatic necrosis that has developed a well-defined inflammatory wall. It is estimated that approximately 10%-15% patients with AP develop WON and majority of patients with WON requires interventions either due to infection, persistent SIRS, persistent organ failure or presence of pressure symptoms like abdominal pain, early satiety, weight loss or biliary duct compression. Management of WON in recent years is mainly done by step-up approach. Depending on the location of WON, it is drained by either endoscopic ultrasound (EUS) guided transluminal drainage or by percutaneous catheter drainage. If WON is predominantly located near the lesser sac or peripancreatic area, EUS guided drainage is feasible, however, if WON is predominantly mesenteric, or paracolic in location, percutaneous approach is used. After initial successful drainage, still 40-55% of patients still require step-up therapies in form of Direct Endoscopic Necrosectomy (DEN) or percutaneous catheter upgradation or Video Assisted Retroperitoneal Debridement (VARD) due to presence of large solid material or larger size of the collection. DEN involves passing the endoscope directly into the cavity and removing the necrosis mechanically(5). In a retrospective study, 47 % patients with WON required DEN in the course of illness and 27 % of these patients required at-least 4 sessions of DEN. In a recent study by L Yan et al, it was showed that around 74 % patients with WON required on demand necrosectomy. It was also shown that Pancreatic Fluid collections(PFCs) >10 cm in size, paracolic extension, or >30% solid necrosis are more likely to require step-up therapy and should be considered for early and aggressive endoscopic reintervention. In the last decade, the technical success and dissemination of knowledge regarding technique of EUS guided drainage of WON has improved drastically with availability of plethora of stents and cautery enhanced stents. However, despite that need for necrosectomy and instruments of necrosectomy still remains the same. Hence, even after achieving technical success in patients with WON, an optimum endoscopic necrosectomy remains an ‘Achilles Hill’ for the clinical success. Frequent requirement of necrosectomy results in repeated hospitalization, prolonged hospitalization, increases morbidity and over healthcare related costs. To circumvent this problem, in recent times, multiple novel devices like EndoRotor or H2O2 guided necrosectomy have been attempted.(15,16) However, availability of special device remains an issue. Moreover, effect of H2O2 guided necrosectomy is modest at best. Gao L et al., did a ex-vivo study on effect of normal saline, 5% sodium bicarbonate, 3% H2O2 and artificial gastric juice. In that study, they found that exposure of artificial gastric juice for 2 hours had highest efficacy in causing liquefaction of pancreatic necrosum compared to other materials. Based on this observation, Powers PC et al., did a multicentric retrospective study on effect of PPI on need for necrosectomy and risk of stent occlusion. In that study, they found that patients on PPI required higher number of necrosectomies compared to patients who were not on PPI (4.6 vs 3.2 respectively, P <0.01) and had higher risk of stent occlusion (20.1% vs 9.5%; p=0.012). Hamm J et al., also did a multicentric retrospective study comparing patients who were on continuous PPI vs not on PPI. In that study as well, patients who were on continuous PPI had higher rate of stent occlusion compared to patients who were not on PPI (29.8% vs 22.5%; p=0.039). However, in absence of any prospective study, role of usage of stoppage of PPI is still not clear. Hence, we decided to conduct a randomized trial to compare role of PPI in patients with WON who are undergoing EUS guided transluminal drainage. |