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
• Interventions: Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis

• 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

Arm && Interventions

Group	Intervention	Description
NAGI BI-FLANGED METAL STENT ALONE FOR DRAINAGE OF WOPN.	Endoscopic ultrasound guided drainage of walled off pancreatic necrosis	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.
NAGI BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WOPN.	Endoscopic ultrasound guided drainage of walled off pancreatic necrosis	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.

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