Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis
| ISRCTN | ISRCTN09186711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09186711 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/07/2010
- Registration date
- 06/09/2010
- Last edited
- 08/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof P Fockens
Scientific
Scientific
Dutch Pancreatitis Study Group
Department of Gastroenterology
Academic Medical Center
PO Box 22660
Amsterdam
1100DD
Netherlands
| Phone | +31 (0)20 566 3632 |
|---|---|
| p.fockens@amc.uva.nl |
Study information
| Study design | Randomised controlled parallel group superiority multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| 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) |
| Study acronym | TENSION |
| Study objectives | 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. |
| Ethics approval(s) | Medical Ethics Committee (MEC), Academic Medical Center, Amsterdam, 31/01/2011, ref: MEC 10/203 |
| Health condition(s) or problem(s) studied | Infected necrotising pancreatitis |
| Intervention | 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 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/03/2011 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 98 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100DD
Netherlands
1100DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Dutch Pancreatitis Study Group
Department of Gastroenterology
PO Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)61 903 0931 |
|---|---|
| p.fockens@amc.uva.nl | |
| Website | http://www.pancreatitis.nl |
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research organisation
Maag Lever Darm Stichting (MLDS) (Netherlands) - partial funding (ref: JB/2009-049)
No information available
Fonds NutsOhra (The Netherlands) - partial funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/01/2018 | Yes | No |
Editorial Notes
08/11/2017: Publication reference added.
19/04/2011: The public and scientific titles were 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 Necrosis: a randomised controlled, parallel group superiority multicentre trial (Dutch Pancreatitis Study Group)
