Condition category
Digestive System
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
05/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes