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.

NCT05632900 | Completed DMC

• 1 other identifier: BFMSP -001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Conditions

ENDOSCOPIC ULTRASONOGRAPHY

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• re-intervention rates

  4 weeks

• Technical success rate

  4 weeks

• Clinical success rate

  4 weeks

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

Endoscopic ultrasound guided drainage of walled off pancreatic necrosis PROCEDURE

It is Therapeutic procedure to treat walled off pancreatic necrosis.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic Walled-off pancreatic necrosis (WON)
• Eligible for EUS guided BFMS placement
• Signed informed consent .
• Age \>18 Years

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Dr Rajesh Gupta

Hyderabad, Telangana, 500082, India

Location

Study Officials

• Rajesh Dr Gupta, MBBS MD DM

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: July 17, 2021
• Primary Completion: October 22, 2022
• Study Completion: December 20, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)