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)

Asian Institute of Gastroenterology, India

Status: Completed

Conditions: ENDOSCOPIC ULTRASONOGRAPHY

Treatments: Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05632900

BFMSP -001

Details and patient eligibility

About

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

Full 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

Enrollment: 76 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

76 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis

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

Active Comparator group

Description:

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.

Treatment:

Procedure: Endoscopic ultrasound guided drainage of walled off pancreatic necrosis