NCT05632900

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.

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• ENDOSCOPIC ULTRASONOGRAPHY

Interventions

Type	Name	Description
PROCEDURE	Endoscopic ultrasound guided drainage of walled off pancreatic necrosis	It is Therapeutic procedure to treat walled off pancreatic necrosis.

Timeline

• Start date: 2021-07-17
• Primary completion: 2022-10-22
• Completion: 2022-12-20
• First posted: 2022-12-01
• Last updated: 2023-02-24

Locations

1 site across 1 country: India