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: - 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
It is Therapeutic procedure to treat walled off pancreatic necrosis.
Dr Rajesh Gupta
Hyderabad, Telangana, India
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.
Time frame: 4 weeks
re-intervention rates
Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent
Time frame: 4 weeks
Technical success rate
Deployment of Stent
Time frame: 4 weeks
Clinical success rate
Resolution of symptoms Resolution of size of walled of necrosis
Time frame: 4 weeks
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