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.
Completed
- Conditions
- infected necrotizing pancreatitisPancreatitis100179661000401810017998
- Registration Number
- NL-OMON38023
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 98
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
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is composite of mortality and major morbidity. Major<br /><br>morbidity is defined as new onset organ failure (cardiac, pulmonary or renal),<br /><br>bleeding requiring intervention, perforation of a visceral organ (except for<br /><br>the stomach in ETN) requiring intervention, enterocutaneous fistula requiring<br /><br>intervention and incisional hernia (including burst abdomen).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the individual components of the primary endpoint,<br /><br>other morbidity such as pancreaticocutaneous fistula, exocrine and/or endocrine<br /><br>pancreatic insufficiency, development of additional fluid collections requiring<br /><br>intervention, biliairy strictures, wound infections, the need for necrosectomy<br /><br>(either endoscopically or surgically), the total number of surgical, endoscopic<br /><br>or radiological (re-) interventions, total length of intensive care- and<br /><br>hospital stay, quality of life, costs per patient with poor outcome, costs per<br /><br>QALY, total direct and indirect medical costs and the total number of<br /><br>cross-over between groups.<br /><br><br /><br>Other research questions:<br /><br>Is endoscopic transluminal catheter drainage (ETD) equally effective as<br /><br>percutaneous catheter drainage (PCD) in preventing necrosectomy?</p><br>