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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49170

Enrollment

Registered

2020-03-09

Start date

2020-04-08

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

infected necrotizing pancreatitis pancreatitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients included in the TENSION trial

Exclusion criteria

Exclusion criteria: No permission for follow up after the TENSION trial

Design outcomes

Primary

Measure	Time frame
In accordance with the original study, the primary endpoint is composite of mortality and major morbidity. Major morbidity is defined as new onset organ failure (cardiac, pulmonary or renal), bleeding requiring intervention, perforation of a visceral organ requiring intervention, enterocutaneous fistula requiring intervention and incisional hernia.	—

Secondary

Measure	Time frame
Secondary endpoints are the individual components of the primary endpoint, other morbidity such as pancreaticocutaneous fistula, exocrine and/or endocrine pancreatic insufficiency, development of additional fluid collections requiring intervention, biliairy strictures, wound infections, the need for necrosectomy (either endoscopically or surgically), the total number of surgical, endoscopic or radiological (re-) interventions, total length of intensive care- and hospital stay, quality of life, costs per patient with poor outcome, costs per QALY, total direct and indirect medical costs and the total number of cross-over between groups.	—

Measure

Time frame

Secondary endpoints are the individual components of the primary endpoint, other morbidity such as pancreaticocutaneous fistula, exocrine and/or endocrine pancreatic insufficiency, development of additional fluid collections requiring intervention, biliairy strictures, wound infections, the need for necrosectomy (either endoscopically or surgically), the total number of surgical, endoscopic or radiological (re-) interventions, total length of intensive care- and hospital stay, quality of life, costs per patient with poor outcome, costs per QALY, total direct and indirect medical costs and the total number of cross-over between groups.

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Countries

Netherlands

Outcome results