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this study is to see whether adding a nasocystic drain over metal stent in drainage of symptomatic pancreatic walled off necrosis has any added benefit

Naso cystic drain with metal stent vs metal stent alone for endoscopic ultrasound guided transluminal drainage of walled off necrosis: A randomized controlled pilot study - .

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079077
Enrollment
40
Registered
2025-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified

Interventions

Intervention1: Metal stent with nasocystic drain in EUS guided transluminal drainage OF walled off necrosis: In one arm, EUS guided transluminal drainage of walled off necrosis will be conducted using

Sponsors

Dr Nilanjan Kar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of acute pancreatitis (AP) with =18 years of age 2. Patients with symptomatic WON requiring EUS guided transluminal drainage 3. Provision of written informed consent

Exclusion criteria

Exclusion criteria: .1. Patients with collection not amenable for EUS guided drainage (distance of WON more than 1 cm from the gastrointestinal lumen) 2. Patients moribund to undergo endoscopic procedure (Glasglow coma scale below 8 or patients on ventilatory support) 3. Patients with underlying calcific pancreatitis 4. Patients with previous history of intervention (endoscopic or surgical) in the collection prior to screening 5. Patients with irreversible coagulopathy like platelets less than 50,000/mm3 and/or INR more than 1.5 6. Pregnant female

Design outcomes

Primary

MeasureTime frame
1. To compare clinical success of Nasocystic drain with metal stent vs metal stent alone for endoscopic ultrasound guided transluminal drainage in patients with symptomatic walled off necrosis 2. To compare need of necrosectomy (endoscopic or surgical) after index drainage procedure to achieve clinical success between the two groups Timepoint: Primary outcome will be assessed at 72 hours of index drainage procedure

Secondary

MeasureTime frame
1. To compare time for resolution of SIRS from index procedure between two groups 2. To compare all-cause mortality due to basic disease and its complications between the two groups 3. To compare procedure related complications as per ASGE- Lexicon guidelines between the two groups Timepoint: secondary outpoints will be assessed at the end of discharge or death

Countries

India

Contacts

Public ContactDR NILANJAN KAR

Post Graduate Institute of Medical Education & Research, Chandigarh

drsurindersrana@gmail.com9872199135

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026