Surgery versus stent for malignant gastro-duodenal obstruction

ISRCTN	ISRCTN06702358
DOI	https://doi.org/10.1186/ISRCTN06702358
Secondary identifying numbers	NTR531; 945-06-503

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr S M Jeurnink
Scientific

Erasmus Medical Center
Department of Gastroenterology and Hepatology
Room HS 510
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)65 495 4623
Email	s.jeurnink@erasmusmc.nl

Study design	Randomised multicentre active-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Surgical gastrojejunostomy or endoscopic duodenal stent placement for the palliation of malignant gastric outlet obstruction: a randomised study
Study acronym	SUSTENT study
Study objectives	To compare a surgical procedure (gastrojejunostomy [GJJ]) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO).
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Gastric outlet obstruction (GOO)
Intervention	1. Duodenal stent placement 2. Gastrojejunostomy
Intervention type	Other
Primary outcome measure	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 study start date	01/01/2006
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	150
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2008

Erasmus Medical Center

Rotterdam
3000 CA
Netherlands

Erasmus Medical Centre (Netherlands)
Hospital/treatment centre

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Website	http://www.erasmusmc.nl/
"ROR"	https://ror.org/018906e22

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	14/10/2006	Yes	No
Results article	results	01/03/2010	Yes	No
Results article	results on cost effectiveness	01/05/2010	Yes	No