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.

ENDOSCOPIC ULTRASONOGRAPHY Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05632900
• Other study ID #: BFMSP -001
• Status: Completed
• Phase: N/A
• Start date: July 17, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 20, 2022
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• ENDOSCOPIC ULTRASONOGRAPHY
• Necrosis
• Pancreatitis, Acute Necrotizing

Intervention

Procedure:
• Endoscopic ultrasound guided drainage of walled off pancreatic necrosis
It is Therapeutic procedure to treat walled off pancreatic necrosis.

Locations

Country	Name	City	State
India	Dr Rajesh Gupta	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	re-intervention rates	Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent	4 weeks
Secondary	Technical success rate	Deployment of Stent	4 weeks
Secondary	Clinical success rate	Resolution of symptoms Resolution of size of walled of necrosis	4 weeks