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.

Not Applicable

Completed

• Conditions: ENDOSCOPIC ULTRASONOGRAPHY

• Registration Number: NCT05632900
• Lead Sponsor: Asian Institute of Gastroenterology, India

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

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 Timeline

• Study Start: 2021-07-17
• Primary Completion: 2022-10-22
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-01
• Study Completion: 2022-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).	4 weeks	To monitor the adverse events like bleeding, stent clogging and stent migration.

Secondary Outcome Measures

Name	Time	Method
re-intervention rates	4 weeks	Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent
Clinical success rate	4 weeks	Resolution of symptoms Resolution of size of walled of necrosis
Technical success rate	4 weeks	Deployment of Stent

Trial Locations

Locations (1)

Dr Rajesh Gupta; 🇮🇳 Hyderabad, Telangana, India