- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05632900
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. (BFMSP)
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
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sathish Dr Chander G, MBBS MD
- Phone Number: 8639567069
- Email: drsathish2404@gmail.com
Study Locations
-
-
Telangana
-
Hyderabad, Telangana, India, 500082
- Dr Rajesh Gupta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional 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.
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.
|
It is Therapeutic procedure to treat walled off pancreatic necrosis.
|
Active Comparator: 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.
|
It is Therapeutic procedure to treat walled off pancreatic necrosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent
|
4 weeks
|
Technical success rate
Time Frame: 4 weeks
|
Deployment of Stent
|
4 weeks
|
Clinical success rate
Time Frame: 4 weeks
|
Resolution of symptoms Resolution of size of walled of necrosis
|
4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rajesh Dr Gupta, MBBS MD DM, Asian Institute of Gastroenterology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BFMSP -001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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