Contact information
Type
Scientific
Primary contact
Dr S M Jeurnink
ORCID ID
Contact details
Erasmus Medical Center
Department of Gastroenterology and Hepatology
Room HS 510
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)65 495 4623
s.jeurnink@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR531; 945-06-503
Study information
Scientific title
Surgical gastrojejunostomy or endoscopic duodenal stent placement for the palliation of malignant gastric outlet obstruction: a randomised study
Acronym
SUSTENT study
Study hypothesis
To compare a surgical procedure (gastrojejunostomy [GJJ]) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO).
Ethics approval
Received from the local medical ethics committee
Study design
Randomised multicentre active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Gastric outlet obstruction (GOO)
Intervention
1. Duodenal stent placement
2. Gastrojejunostomy
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Total area under the survival curve, adjusted for the ability to eat at least soft solids (GOOSS score of 2 or more).
Secondary outcome measures
1. Procedure-related (within 7 days) and long term (later than 7 days) minor and major complications
2. Reinterventions or recurrent obstructions
3. Survival, calculated from day of randomisation
4. Health related quality of life, including the perceived burden of the procedure, burden of reintervention and generic and disease specific HRQoL
5. Cost and cost-effectiveness
Overall trial start date
01/01/2006
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Obstructive cancer (more than 25% of the circumference as seen by endoscopy) extending from the distal duodenum
2. Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only)
3. Incurable or metastatic disease
4. Informed consent
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
150
Participant exclusion criteria
1. Evidence of other strictures in the gastrointestinal (GI) tract
2. Previous gastric, periampullary or duodenal surgery
3. Previous (palliative) treatment for the same condition
4. World Health Organization (WHO) performance score of 4 (patient is 100% of time in bed)
5. Unable to fill out quality of life questionnaires
Recruitment start date
01/01/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
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
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17076365 [Dutch]
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20003966
3. 2009 results on cost effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/20033227
Publication citations
-
Results
Jeurnink SM, Steyerberg EW, van Hooft JE, van Eijck CH, Schwartz MP, Vleggaar FP, Kuipers EJ, Siersema PD, , Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial., Gastrointest. Endosc., 2010, 71, 3, 490-499, doi: 10.1016/j.gie.2009.09.042.
-
Results on cost effectiveness
Jeurnink SM, Polinder S, Steyerberg EW, Kuipers EJ, Siersema PD, Cost comparison of gastrojejunostomy versus duodenal stent placement for malignant gastric outlet obstruction., J. Gastroenterol., 2010, 45, 5, 537-543, doi: 10.1007/s00535-009-0181-0.
-
Jeurnink SM, Steyerberg EW, van Eijck CH, Kuipers EJ, Siersema PD, [Gastrojejunostomy versus endoscopic stent placement as palliative treatment for a malignant constriction of the duodenum: the SUSTENT-study]., Ned Tijdschr Geneeskd, 2006, 150, 41, 2270-2272.