Surgery versus stent for malignant gastro-duodenal obstruction
| ISRCTN | ISRCTN06702358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06702358 |
| Protocol serial number | NTR531; 945-06-503 |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funder | Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 05/01/2010
- 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
Dr S M Jeurnink
Scientific
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 |
|---|---|
| s.jeurnink@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised multicentre active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Total area under the survival curve, adjusted for the ability to eat at least soft solids (GOOSS score of 2 or more). |
| Key secondary outcome measure(s) |
1. Procedure-related (within 7 days) and long term (later than 7 days) minor and major complications |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
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 | 01/03/2010 | Yes | No | |
| Results article | results on cost effectiveness | 01/05/2010 | Yes | No | |
| Protocol article | protocol | 14/10/2006 | Yes | No |
