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Completed

NCT Number: NCT05632900

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 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

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Key information

Conditions

Endoscopic Ultrasonography

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Rajesh Gupta

Hyderabad, Telangana, 500082, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic ultrasound guided drainage of walled off pancreatic necrosis

Procedure

It is Therapeutic procedure to treat walled off pancreatic necrosis.

Primary outcomes

  1. Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).

    Time frame: 4 weeks

    To monitor the adverse events like bleeding, stent clogging and stent migration.

Secondary outcomes

  1. re-intervention rates

    Time frame: 4 weeks

    Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent

  2. Technical success rate

    Time frame: 4 weeks

    Deployment of Stent

  3. Clinical success rate

    Time frame: 4 weeks

    Resolution of symptoms Resolution of size of walled of necrosis

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study 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

Acronym: BFMSP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2022
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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