Transluminal Endoscopic step-up approach versus miNimally invasive SurgIcal step-up apprOach in patients with infected pancreatic Necrosis: TENSION, a randomized controlled parallel-group superiority multicenter trial. Dutch Pancreatitis Study Group.

Transluminal Endoscopic step-up approach versus miNimally invasive SurgIcal step-up apprOach in patients with infected pancreatic Necrosis: TENSION, a randomized controlled parallel-group superiority multicenter trial. Dutch Pancreatitis Study Group. - TENSION

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38023

Enrollment

Registered

2011-10-13

Start date

2011-09-20

Completion date

Unknown

Last updated

2024-05-06

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

Endoscopic transluminal step-up approach (ETD and ETN).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Pancreatic necrosis and/or peripancreatic necrosis with (suspected or confirmed) infection. (See protocol, page 15-16 for definitions) * The peripancreatic collection is amenable to the endoscopic transluminal step-up approach as well as the surgical step-up approach. * Age * 18 years and informed consent.

Exclusion criteria

Exclusion criteria: * Previous surgical, endoscopic or percutaneous intervention for pancreatic necrosis and/or peripancreatic necrosis and/or peripancreatic collections. (See protocol, page 16 for definition) * Acute flare up of chronic pancreatitis. * Concomitant indication for laparotomy because of suspected abdominal compartment syndrome, bleeding or perforation of a visceral organ.

Design outcomes

Primary

Measure	Time frame
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 (except for the stomach in ETN) requiring intervention, enterocutaneous fistula requiring intervention and incisional hernia (including burst abdomen).	—

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. Other research questions: Is endoscopic transluminal catheter drainage (ETD) equally effective as percutaneous catheter drainage (PCD) in preventing necrosectomy?	—

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. Other research questions: Is endoscopic transluminal catheter drainage (ETD) equally effective as percutaneous catheter drainage (PCD) in preventing necrosectomy?

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)