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AXIOMA: Hot AXios metal stent for Infected necrOsis Management.


- candidate number28561
- NTR NumberNTR7056
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-feb-2018
- Secondary IDsNL63218.018.17 METC AMC Amsterdam
- Public TitleAXIOMA: Hot AXios metal stent for Infected necrOsis Management.
- Scientific TitleAXIOMA: Hot AXios metal stent for Infected necrOsis MAnagement.
- ACRONYMAXIOMA
- hypothesisThe use of LAMS (lumen-apposing fully covered self-expanding metal stents) will optimize endoscopic drainage in patients with infected walled-off necrosis, and therefore reduce the need for additional endoscopic necrosectomy and its associated morbidity and costs.
- Healt Condition(s) or Problem(s) studiedPancreatitis, Necrosis, Infection, Hot AXIOS stent
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2018
- planned closingdate1-mrt-2021
- Target number of participants52
- InterventionsEndoscopic transluminal drainage with the Hot AXIOS stent
- Primary outcomePrimary endpoint is the need for additional (endoscopic) necrosectomy to achieve clinical success.
- Secondary outcome- Mortality
- Endoscopic morbidity (bleeding, perforation, stent migration or stent dysfunction)
- New onset (multi-)organ failure (cardiovascular, pulmonary, renal)
- Additional radiological, endoscopic or surgical interventions
- Hospital and ICU length of stay
- Pancreaticocutaneous fistula
- Exocrine and/or endocrine pancreatic insufficiency
- Medical costs
- QALYs
- Timepoints1. 6 weeks: MRI/MRCP (before 2.)
2. 6 weeks: stent removal
3. Follow-up 3 months: exocrine and endocrine pancreatic function, questionnaires (SF-36, EQ-5D, SF-HLQ)
4. Follow-up 6 months: MRI/MRCP, exocrine and endocrine pancreatic function, questionnaires (SF-36, EQ-5D, SF-HLQ)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. L. Boxhoorn
- CONTACT for SCIENTIFIC QUERIESDr. P. Fockens
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam, Boston Scientific
- Publications
- Brief summaryInfected (peri)pancreatic necrosis is a life-threatening complication of acute pancreatitis. Current guidelines recommend a step-up approach in these patients, starting with catheter drainage, and if necessary, followed by a minimal invasive necrosectomy. Recent literature demonstrated no difference in mortality and major morbidity between endoscopic and minimal invasive surgical management for infected walled-off necrosis. However, endoscopic therapy resulted in shorter hospital stay and less pancreatic fistulas. These findings suggest that endoscopic treatment should be the preferred treatment modality in patients with infected walled-off necrosis. The use of LAMS (lumen-apposing metal stents), like the Hot AXIOS stent, might optimize endoscopic drainage even more and reduce the need for additional necrosectomy and its associated morbidity and costs.

This will be investigated in the AXIOMA study, a prospective multicenter study performed in the centers of the nationwide Dutch Pancreatitis Study Group. This cohort of patients will be compared to the 58 endoscopically treated patients of the Dutch TENSION and the PENGUIN trial.
- Main changes (audit trail)
- RECORD10-feb-2018 - 15-mrt-2018


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