Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis

Mayo Clinic

Status: Withdrawn

Conditions: Necrotizing Pancreatitis

Treatments: Device: Double Pigtail Plastic Stent; Device: AXIOS Metal Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02564965

14-001390

Details and patient eligibility

About

The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (> 18 yo) patients
• With symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging
• Must have solid necrotic material present in their pancreatic fluid collection as determined by MRI, EUS, or direct transluminal endoscopic imaging of the collection

Exclusion criteria

• Previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic)
• Indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a GI lumen)
• Uncorrectable coagulopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Greater than 50% Necrosis

Other group

Description:

Subjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.

Treatment:

Device: AXIOS Metal Stent

Device: Double Pigtail Plastic Stent

Less than 50% Necrosis

Other group

Description:

Subjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.

Treatment:

Device: AXIOS Metal Stent

Device: Double Pigtail Plastic Stent