search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis


- candidate number15238
- NTR NumberNTR4142
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2013
- Secondary IDsTENSION trial 
- Public TitleTransluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis
- Scientific TitleTransluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis: TENSION, a randomised controlled parallel-group superiority multicentre trial (Dutch Pancreatitis Study Group)
- ACRONYMTENSION
- hypothesisWe hypothesise that the endoscopic transluminal 'step-up' approach, compared to the surgical 'step-up'approach, reduces mortality, major morbidity and costs in patients with (suspected or confirmed) infected necrotising pancreatitis
- Healt Condition(s) or Problem(s) studiedInfected necrotising pancreatitis, Minimally invasive, Endoscopic drainage, Endoscopic necrosectomy, Percutaneous drainage, Surgical necrosectomy
- Inclusion criteria1. Pancreatic necrosis and/or peripancreatic necrosis with (suspected or confirmed) infection
2. The peripancreatic collection is amenable to the endoscopic 'step-up' approach as well as the surgical 'step-up' approach
3. Age greater than or equal to 18 years (either sex) and informed consent
- Exclusion criteria1. Previous surgical, endoscopic or percutaneous intervention for pancreatic necrosis and/or peripancreatic necrosis and/or peripancreatic collections
2. Acute flare up of chronic pancreatitis
3. Concomitant indication for emergency laparotomy because of suspected abdominal compartment syndrome, bleeding or perforation of a visceral organ
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate31-dec-2015
- Target number of participants98
- Interventions1. Intervention group: endoscopic step-up approach, consisting of endoscopic catheter drainage (ETD) and endoscopic necrosectomy (ETN)

2. Control group: surgical step-up approach, consisting of percutaneous catheter drainage (PCD) and video assisted retroperitoneal debridement (VARD), if not possible laparotomy
- Primary outcomeComposite 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 (including burst abdomen).
- Secondary outcome1. Individual components of primary composite endpoint
2. Other morbidity such as pancreaticocutaneous fistula
3. Exocrine and/or endocrine pancreatic insufficiency
4. Development of additional fluid collections requiring intervention
5. Biliary strictures
6. Wound infections
7. The need for necrosectomy (either endoscopically or surgically)
8. The total number of surgical, endoscopic or radiological (re-) interventions
9. Total length of intensive care and hospital stay
10. Quality of life
11. Costs per patient with poor outcome
12. Costs per quality adjusted life year (QALY)
13. Total direct and indirect medical costs
14. Total number of cross-overs between groups
- TimepointsPrimary and secondary outcome are measured 6 months after randomisation.
- Trial web sitewww.pancreatitis.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Brunschot, van
- CONTACT for SCIENTIFIC QUERIES S. Brunschot, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Maag Lever Darm Stichting (MLDS), Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryThe TENSION trial compares an endoscopic with a surgical step-up approach in patients with infected pancreatic necrosis. The primary endpoint is a composite of mortality and major morbidity.
- Main changes (audit trail)
- RECORD5-aug-2013 - 16-sep-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl