Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-29 @ 4:47 PM
Study NCT ID:
NCT05632900
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2022-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
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.
Sponsor:
Asian Institute of Gastroenterology, India
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BFMSP
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
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: -
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: