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Recruiting NCT05632900

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

Conditions: ENDOSCOPIC ULTRASONOGRAPHY

Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 64
Sponsor: Asian Institute of Gastroenterology, India

Location: India

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

Eligibility Criteria

Inclusion Criteria:Symptomatic Walled-off pancreatic necrosis (WON)Eligible for EUS guided BFMS placementSigned informed consent .Age >18 YearsExclusion Criteria:Types of pancreatic collections other than WON .Drainage with stents other than BFMSPrevious attempts at drainage of WONCoagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable.PregnancyNot willing to give informed consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05632900). StuddyBuddy aggregates publicly available trial information.