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18 May 2013
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| [ Print-friendly version ] |
| Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis |
| ISRCTN | ISRCTN09186711 |
| DOI | 10.1186/ISRCTN09186711 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis |
| Scientific title | Transluminal 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). |
| Acronym | TENSION |
| Serial number at source | N/A |
| Study hypothesis |
We hypothesise that the endoscopic transluminal 'step-up' approach, compared to the surgical 'step-up'approach, reduces mortality and/or major morbidity in patients with (suspected or confirmed) infected necrotising pancreatitis.
Please note, as of 19/04/2011 the public and scientific titles of this trial have been updated. Previous titles were as follows: Public: Transluminal ENdoscopic versus SurgIcal necrOsectomy in patients with infected pancreatic Necrosis Scientific: Transluminal ENdoscopic versus SurgIcal necrOsectomy in patients with infected pancreatic Scientific: Necrosis: a randomised controlled, parallel group superiority multicentre trial (Dutch Pancreatitis Study Group) |
| Lay summary | |
| Ethics approval |
Medical Ethics Committee (MEC), Academic Medical Center, Amsterdam on 31/01/2011
(ref: MEC 10/203) |
| Study design | Randomised controlled parallel group superiority multicentre trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Infected necrotising pancreatitis |
| Participants - inclusion criteria |
1. Pancreatic necrosis and/or peripancreatic necrosis with (suspected or confirmed) infection
2. The peripancreatic collection is amenable to the endoscopic transluminal 'step-up' approach as well as the surgical 'step-up' approach 3. Aged greater than or equal to 18 years (either sex) and informed consent |
| Participants - exclusion criteria |
1. 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 laparotomy because of suspected abdominal compartment syndrome, bleeding or perforation of a visceral organ |
| Anticipated start date | 01/03/2011 |
| Anticipated end date | 31/12/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 98 |
| Interventions |
1. Intervention group: endoscopic transluminal step-up approach, consisting of endoscopic transluminal catheter drainage (ETD) and endoscopic transluminal 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 4. The total duration of follow-up is 6 months after discharge. There is no total duration of treatment because patients will be randomized at different moments. This depends on the fact when infected necrotizing pancreatitis is suspected or confirmed. This can be 30 days after admission but also 90 days after admission. |
| Primary outcome measure(s) | 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). Measured at 6 months. |
| Secondary outcome measure(s) |
Measured at 6 months:
1. 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 |
| Sources of funding |
1. Maag Lever Darm Stichting (MLDS) (Netherlands) - partial funding (ref: JB/2009-049)
2. Fonds NutsOhra (The Netherlands) - partial funding |
| Trial website | http://www.pancreatitis.nl |
| Publications | |
| Contact name | Prof P Fockens |
| Address |
Dutch Pancreatitis Study Group
Department of Gastroenterology Academic Medical Center PO BOX 22660 |
| City/town | Amsterdam |
| Zip/Postcode | 1100DD |
| Country | Netherlands |
| Tel | +31 (0)20 566 3632 |
| p.fockens@amc.uva.nl | |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Address |
Dutch Pancreatitis Study Group
Department of Gastroenterology PO BOX 22660 |
| City/town | Amsterdam |
| Zip/Postcode | 1100 DD |
| Country | Netherlands |
| Tel | +31 (0)61 903 0931 |
| Fax | +31 (0)24 361 3834 |
| p.fockens@amc.uva.nl | |
| Sponsor website: | http://www.pancreatitis.nl |
| Date applied | 27/07/2010 |
| Last edited | 19/04/2011 |
| Date ISRCTN assigned | 06/09/2010 |
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