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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 - A PROSPECTIVE RANDOMISED CONTROLLED STUDY. (BFMSP)

Primary Purpose

ENDOSCOPIC ULTRASONOGRAPHY

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ENDOSCOPIC ULTRASONOGRAPHY

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr Rajesh Gupta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.

NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.

Arm Description

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 -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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

re-intervention rates
Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent
Technical success rate
Deployment of Stent
Clinical success rate
Resolution of symptoms Resolution of size of walled of necrosis

Full Information

First Posted
November 21, 2022
Last Updated
February 22, 2023
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT05632900
Brief Title
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.
Acronym
BFMSP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2021 (Actual)
Primary Completion Date
October 22, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ENDOSCOPIC ULTRASONOGRAPHY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.
Arm Type
Experimental
Arm Description
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.
Arm Title
NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
Intervention Description
It is Therapeutic procedure to treat walled off pancreatic necrosis.
Primary Outcome Measure Information:
Title
Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).
Description
To monitor the adverse events like bleeding, stent clogging and stent migration.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
re-intervention rates
Description
Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent
Time Frame
4 weeks
Title
Technical success rate
Description
Deployment of Stent
Time Frame
4 weeks
Title
Clinical success rate
Description
Resolution of symptoms Resolution of size of walled of necrosis
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Dr Gupta, MBBS MD DM
Organizational Affiliation
Asian Institute of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Rajesh Gupta
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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