COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS - A PROSPECTIVE RANDOMISED CONTROLLED STUDY. — BFMSP  

ENDOSCOPIC ULTRASONOGRAPHY Clinical Trial

Official title: COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS

Status Completed

Clinical Trial Summary

Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management.

But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration .

This study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not.

There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone.

one study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS .

But there has been no prospective RCT to assess the utility of DPS to date

Clinical Trial Description

Inclusion Criteria: -

1. Symptomatic Walled-off pancreatic necrosis (WON)

2. Eligible for EUS guided BFMS placement

3. Signed informed consent .

4. Age >18 Years

Exclusion Criteria: -

1. Types of pancreatic collections other than WON .

2. Drainage with stents other than BFMS

3. Previous attempts at drainage of WON

4. Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.

5. Pregnancy

6. Not willing to give informed consent ;

Related Conditions & MeSH terms

• ENDOSCOPIC ULTRASONOGRAPHY
• Necrosis
• Pancreatitis, Acute Necrotizing

• NCT number: NCT05632900
• Study type: Interventional
• Source: Asian Institute of Gastroenterology, India
• Status: Completed
• Phase: N/A
• Start date: July 17, 2021
• Completion date: December 20, 2022