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.

Study Overview
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Brief Summary
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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
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Inclusion Criteria: - Symptomatic Walled-off pancreatic necrosis (WON) Eligible for EUS guided BFMS placement Signed informed consent . Age >18 Years Exclusion Criteria: - Types of pancreatic collections other than WON . Drainage with stents other than BFMS Previous attempts at drainage of WON Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable. Pregnancy Not willing to give informed consent

Official Title
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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

Conditions
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ENDOSCOPIC ULTRASONOGRAPHY

Intervention / Treatment
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* Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic Walled-off pancreatic necrosis (WON) Eligible for EUS guided BFMS placement Signed informed consent . Age >18 Years Exclusion Criteria: Types of pancreatic collections other than WON . Drainage with stents other than BFMS Previous attempts at drainage of WON Coagulopathy (INR>1.5) or thrombocytopenia(plc <50000/cmm)- not correctable. Pregnancy Not willing to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.<br>Endoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long with co Axial double pig tail stent used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection. | Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis<br>* It is Therapeutic procedure to treat walled off pancreatic necrosis.<br>|
| Active Comparator: NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.<br>Endoscopic ultrasound guided drainage -Nagi Bi Flanged metal stent--16mm diameter 2cm long used for drainage of walled of necrosis. Intra and post prodecural complications will be noted, a plane CT screening abdomen will be performed with in 48 to 72 hours to document the size of collection. | Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis<br>* It is Therapeutic procedure to treat walled off pancreatic necrosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding). | To monitor the adverse events like bleeding, stent clogging and stent migration. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-intervention rates | Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent | 4 weeks | 
| Technical success rate | Deployment of Stent | 4 weeks | 
| Clinical success rate | Resolution of symptoms Resolution of size of walled of necrosis | 4 weeks |