Multi centre randomised prospective trial of duodenal stenting versus surgical gastrojejunostomy for palliative relief of gastric outlet obstruction secondary to inoperable peri-ampullary cancers
| ISRCTN | ISRCTN52981264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52981264 |
| Protocol serial number | N0256107988 |
| Sponsor | Department of Health (UK) |
| Funder | The Royal Free Hampstead NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 23/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Robert Hutchins
Scientific
Scientific
University Department of Surgery
The Royal Free & University Medical School
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Which method of gastric bypass offers the best palliation with lowest cost and least mortality and morbidity? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Gastric bypass |
| Intervention | Patients randomised to receive duodenal stenting or surgical bypass. Followed up until death with analysis of morbidity, mortality, survival, cost, readmission rates, palliation of symptoms and quality of life. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
30 Day mortality, morbidity, cost, quality of life, survival after treatment, recurrent hospital admissions and reasons, successful placement of stents, return to nutrition and level of return to nutrition. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 03/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 70 |
| Key inclusion criteria | 35 patients in each group. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 03/01/2002 |
| Date of final enrolment | 03/01/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Department of Surgery
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
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 | 01/06/2007 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
