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A study to compare the performance of two different metal stents used for endoscopic drainage of fluid collections that develops after acute pancreatitis

Comparison of two different lumen-apposing metal stents for endoscopic ultrasound-guided drainage of pancreatic fluid collections: A randomized controlled trial - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077427
Enrollment
152
Registered
2024-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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: EUS-guided drainage using Hot-SPAXUS system: After informed consent, EUS-guided drainage of WON will be carried out using a linear array echoendoscope either with or without fluoroscopy

Sponsors

Jayanta Samanta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of WON Symptomatic patients with WON requiring drainage Amenable for EUS-guided drainage Informed consent

Exclusion criteria

Exclusion criteria: ANC less than 4 weeks Pancreatic pseudocyst Previous intervention or drainage Asymptomatic collections bleeding diathesis, uncorrectable coagulopathy or thrombocytopenia precluding drainage underlying malignancy pregnant female

Design outcomes

Primary

MeasureTime frame
Number of patients who experienced overall bleeding events post index EUS-drainage of WONTimepoint: 6 months

Secondary

MeasureTime frame
1. Overall adverse events post EUS-D 2. Technical success 3. Clinical success 4. Need for reintervention 5. Hospital stays, ICU stay, ventilatory stay (post index drainage procedure) 6. Mortality rates Timepoint: 6 months

Countries

India

Contacts

Public ContactJayanta Samanta

Postgraduate Institute of Medical Education and Research, Chandigarh

dj_samanta@yahoo.co.in9855319529

Outcome results

None listed

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