No registrations found.
ID
Source
Brief title
Health condition
Pancreatitis
Necrosis
Infection
Hot AXIOS stent
Sponsors and support
- Amsterdam UMC
Intervention
Outcome measures
Primary outcome
The need for additional endoscopic transluminal necrosectomy
Secondary outcome
- Mortality
- New-onset organ failure (cardiovascular, pulmonary, renal)
- Bleeding requiring intervention
- Perforation of a visceral organ requiring intervention and/or enterocutaneous fistula
- Pancreaticocutaneous fistula
- Biliary stricture
- Total number of radiological, endoscopic or surgical interventions for infected necrosis
- Hospital and ICU length of stay
- Exocrine and/or endocrine pancreatic insufficiency
- Medical costs
Background summary
Infected (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 the endoscopic and surgical step-up approach for infected necrotizing pancreatitis. However, the endoscopic step-up approach resulted in shorter hospital stay and less pancreatic fistulas. These findings suggest that the endoscopic step-up approach should be the preferred treatment modality in patients with infected necrotizing pancreatitis. The use of lumen-apposing metal stents (LAMS), like the Hot-AXIOS stent, might optimize endoscopic drainage even more and reduce the need for additional endoscopic transluminal 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 51 endoscopically treated patients of the Dutch TENSION trial.
Study objective
The use of LAMS (lumen-apposing fully covered self-expanding metal stents) will optimize endoscopic drainage in patients with infected necrotizing pancreatitis, and therefore reduce the need for additional endoscopic necrosectomy and its associated morbidity and costs.
Study design
1. 6 weeks: MRI/MRCP (before 2.)
2. 6 weeks: Hot AXIOS-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)
Intervention
Endoscopic transluminal drainage with the Hot AXIOS stent
L. Boxhoorn
PO Box 2500
Nieuwegein 3430 EM
The Netherlands
l.boxhoorn@amsterdamumc.nl
l.boxhoorn@pancreatitis.nl
L. Boxhoorn
PO Box 2500
Nieuwegein 3430 EM
The Netherlands
l.boxhoorn@amsterdamumc.nl
l.boxhoorn@pancreatitis.nl
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6878 |
| NTR-old | NTR7056 |
| CCMO | NL63218.018.17 |
| OMON | NL-OMON50645 |