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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
Inclusion Criteria: -
Exclusion Criteria: -
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN. | Experimental | 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. |
|
| NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN. | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound guided drainage of walled off pancreatic necrosis | Procedure | It is Therapeutic procedure to treat walled off pancreatic necrosis. |
|
| 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 |
| 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 |
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Dr Gupta, MBBS MD DM | Asian Institute of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Rajesh Gupta | Hyderabad | Telangana | 500082 | India |
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| 4 weeks |
| Clinical success rate | Resolution of symptoms Resolution of size of walled of necrosis | 4 weeks |