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.
NCT ID: NCT05632900
Last Updated: 2023-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2021-07-17
2022-12-20
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.
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.
Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
It is Therapeutic procedure to treat walled off pancreatic necrosis.
NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.
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.
Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
It is Therapeutic procedure to treat walled off pancreatic necrosis.
Interventions
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Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
It is Therapeutic procedure to treat walled off pancreatic necrosis.
Eligibility Criteria
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Inclusion Criteria
2. Eligible for EUS guided BFMS placement
3. Signed informed consent .
4. Age \>18 Years
Exclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Mohan Ramchandani
Doctor
Principal Investigators
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Rajesh Dr Gupta, MBBS MD DM
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology
Locations
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Dr Rajesh Gupta
Hyderabad, Telangana, India
Countries
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Other Identifiers
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BFMSP -001
Identifier Type: -
Identifier Source: org_study_id
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