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
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funders	Maag Lever Darm Stichting (MLDS) (Netherlands) - partial funding (ref: JB/2009-049), Fonds NutsOhra (The Netherlands) - partial funding

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

Dutch Pancreatitis Study Group
Department of Gastroenterology
Academic Medical Center
PO Box 22660
Amsterdam
1100DD
Netherlands

Phone	+31 (0)20 566 3632
Email	p.fockens@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel group superiority multicentre trial
Secondary study design	Randomised parallel trial
Study type	Participant 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(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.
Key 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
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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)