AXIOMA: Hot AXIOS metal stent for infected walled-off pancreatic necrosis management.

Completed

• Conditions: Endoscopische verrichtingen; Infected necrotizing pancreatitis; 10015674; 10017998

• Registration Number: NL-OMON50645
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-04-16
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

- * 18 years old
- Written informed consent
- Walled-off pancreatic necrosis
- Suspected or documented infected walled-off pancreatic necrosis
- Endoscopic transluminal drainage is technically feasible as deemed by the
Expert panel and/or treating physician.

Exclusion Criteria

- Previous invasive intervention for (peri)pancreatic necrosis and/or
peripancreatic collections
- Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding,
bowel perforation, abdominal compartment syndrome)
- Documented chronic pancreatitis according to the M-ANNHEIM criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the need for additional (endoscopic) necrosectomy to<br /><br>achieve clinical success.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Endoscopic morbidity (bleeding, perforation, stent migration or stent<br /><br>dysfunction)<br /><br>- Mortality<br /><br>- Pancreaticocutaneous fistula<br /><br>- Biliary stricture, requiring ERPC or PTC<br /><br>- New onset organ failure (cardiovascular, pulmonary, renal)<br /><br>- Additional radiological, endoscopic or surgical interventions<br /><br>- Number of endoscopic, radiological or surgical intervention<br /><br>- Total length of hospital stay<br /><br>- Exocrine and/or endocrine pancreatic insufficiency<br /><br>- Total length of Intensive care stay<br /><br>- Disease related death<br /><br>- Overall survival<br /><br>- Medical costs</p><br>