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

Necrotizing Pancreatitis Clinical Trial

Official title:

Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis: A Prospective, Randomized Noninferiority Trial.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02564965
• Other study ID #: 14-001390
• Status: Withdrawn
• Phase: N/A
• Start date: February 2019
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Necrosis
• Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

Device:
• Double Pigtail Plastic Stent
Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent
• AXIOS Metal Stent
Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)		Baseline to 4 months after initiation of endoscopic treatment
Secondary	Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction		Baseline to 4 months after initiation of endoscopic treatment
Secondary	Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)		Baseline to 4 months after initiation of endoscopic treatment
Secondary	Decrease in incidence of adverse events		Baseline to 4 months after initiation of endoscopic treatment
Secondary	Decrease in number of hospital days during treatment course		Baseline to 4 months after initiation of endoscopic treatment
Secondary	Decrease in total costs of pancreatitis-related health care during treatment course		Baseline to 4 months after initiation of endoscopic treatment

External Links

•   Mayo Clinic Clinical Trials