Condition category
Digestive System
Date applied
27/07/2010
Date assigned
06/09/2010
Last edited
19/04/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pancreatitis.nl

Contact information

Type

Scientific

Primary contact

Prof P Fockens

ORCID ID

Contact details

Dutch Pancreatitis Study Group
Department of Gastroenterology
Academic Medical Center
PO BOX 22660
Amsterdam
1100DD
Netherlands
+31 (0)20 566 3632
p.fockens@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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)

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

98

Participant 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

Recruitment start date

01/03/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dutch Pancreatitis Study Group
Amsterdam
1100DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Dutch Pancreatitis Study Group
Department of Gastroenterology
PO BOX 22660
Amsterdam
1100 DD
Netherlands
+31 (0)61 903 0931
p.fockens@amc.uva.nl

Sponsor type

Hospital/treatment centre

Website

http://www.pancreatitis.nl

Funders

Funder type

Research organisation

Funder name

Maag Lever Darm Stichting (MLDS) (Netherlands) - partial funding (ref: JB/2009-049)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fonds NutsOhra (The Netherlands) - partial funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes