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: Completed
• Conditions: ENDOSCOPIC ULTRASONOGRAPHY
• Intervention / Treatment: Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis

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

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Dr Rajesh Gupta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.	Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis; 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.	Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis; 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).	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	Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent	4 weeks
Technical success rate	Deployment of Stent	4 weeks
Clinical success rate	Resolution of symptoms Resolution of size of walled of necrosis	4 weeks

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Rajesh Dr Gupta, MBBS MD DM, Asian Institute Of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2021
• Primary Completion (Actual): October 22, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pancreatic Diseases; Pancreatitis; Necrosis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: BFMSP -001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No