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ExTENSION. Long-term outcomes of a step-up endoscopic versus a surgical step-up approach in patients with infected pancreatic necrosis.

Transluminal Endoscopic step-up approach versus miNimally invasive Surglcal step-up approach in patients with infected pancreatic Necrosis (TENSION). Long-term outcomes of a step-up endoscopic versus surgical step-up approach

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22403
Enrollment
60
Registered
2020-04-29
Start date
2020-04-29
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infected necrotizing pancreatitis

Interventions

Collection of stool samples, sample of blood is drawn and quality of life questionnaires will be obtained.

Sponsors

Amsterdam UMC – location AMC, Dutch pancreatitis study group (PWN)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: surviving patients of the TENSION trial who signed IFC

Exclusion criteria

Exclusion criteria: patients not willing to participate

Design outcomes

Primary

MeasureTime frame
The primary endpoint is composite of death and major complications, defined as new onset organ failure (cardiac, pulmonary or renal), incisional hernia, bleeding requiring intervention, perforation of a visceral organ requiring intervention or enterocutaneous fistula requiring intervention.

Secondary

MeasureTime frame
The secondary clinical endpoints contain the separate individual components of the primary endpoint, pancreaticocutaneous fistula, recurrent pancreatitis, chronic pancreatitis according to the M-ANNHEIM diagnostic criteria, the need for additional catheter drainage or necrosectomy (either endoscopic or surgical), the total number of surgical, endoscopic or radiological (re-)interventions, biliary strictures, wound infections and exocrine and/or endocrine pancreatic insufficiency.

Contacts

Public ContactAnke Onnekink

Amsterdam UMC

a.m.onnekink@amsterdamumc.nl0205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)