The role of endoluminal stenting in the acute management of obstructing colorectal cancer
| ISRCTN | ISRCTN13846816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13846816 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/05/2008
- Registration date
- 27/06/2008
- Last edited
- 22/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Laura Magill
Scientific
Scientific
Birmingham Clinical Trials Unit (BCTU)
Institute of Applied Health Research
College of Medical and Dental Sciences
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 415 9105 |
|---|---|
| e.l.magill@bham.ac.uk |
Prof James Hill
Scientific
Scientific
Manchester University Hospitals NHS Foundation Trust
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
Study information
| Study design | Open multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The role of endoluminal stenting in the acute management of obstructing colorectal cancer |
| Study acronym | CReST |
| Study objectives | For patients presenting acutely with obstructing left-sided colorectal cancer will be randomised between emergency surgery or endoluminal stenting. The aim of the study is to determine if endoluminal stenting results in: 1. A reduced perioperative morbidity as assessed by the length of hospital stay 2. Reduced perioperative morbidity 3. Reduced stoma formation |
| Ethics approval(s) | Oxford Research Ethics Committee B, 22/10/2008, ref: 08/H0605/90 |
| Health condition(s) or problem(s) studied | Obstructing colorectal cancer |
| Intervention | An open randomised controlled trial where patients will be randomised between emergency surgery and endoluminal stenting. All patients will present in the acute setting and will be put forward for urgent decompression. Patients will be randomised between: 1. Endoluminal stenting 2. Surgical decompression with or without resection of the primary tumour |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measures as of 13/03/2017: 1. Length of hospital stay, measured using site-completed trial-specific Case Report Forms at discharge and 12-month follow-up 2. 30-day mortality, measured using mortality data from ONS (also included on CRFs) at 30 days Previous primary outcome measures: 1. Length of hospital stay 2. 30-day mortality 3. Presence and duration of a stoma |
| Secondary outcome measures | Current secondary outcome measures as of 13/03/2017: Data collection points were baseline (screening/randomisation/procedure); discharge; 6 weeks; every 3 months in first year; every 6 months to 3 years: 1. Presence and duration of stoma, measured using intraoperative and discharge Forms (emergency and elective surgery), annual follow up forms 2. Stenting completion and complication rates, measured using stent insertion and stent follow up forms, following stenting at day 7 and day 28 post-stenting and up to 12 months 3. Anastomosis rate, measured using intraoperative form and discharge form, following emergency and elective surgery up to 12 months and then annually 4. 6-month survival, measured using ONS mortality data (also collected on CRFs) at 6 months 5. Quality of life, measured using patient-completed EORTC QLQ C30, QLQ CR29 and EQ-5D at discharge, 3 months and 1 year 6. Proportion disease free at 3 years, measured using ONS Cancer Registry data (also collected on CRFs) at 3 years 7. Length of stay in HRU and ITU, measured using intraoperative and discharge forms following emergency and elective surgery, and discharge form following stenting 8. Perioperative morbidity, measured using intraoperative and discharge forms for emergency and elective surgery 9. Cost benefit analysis, assessed using discharge forms (for bed days) 10. Rate of adjuvant chemotherapy and adherence to chemotherapy protocol, measured using annual follow-up forms Previous secondary outcome measures: 1. Stenting completion and complication rate (arm A only). Complications will be recorded between 24 hours and 7 days (early) and between 7 and 28 days (late). 2. Anastomosis rate, recorded during surgery 3. Quality of life, measured by the EQ-5D and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer patients C29 and C30 at 6 weeks after surgery, then every 3 months for the first year, and every 6 months thereafter until 3 years 4. Proportion recurrence-free at three years (attempted curative surgery group only) 5. Length of stay on intensive treatment unit (ITU) and high-dependency unit (HDU) at 30 days post-operation 6. Perioperative morbidity 7. Cost benefit analysis |
| Overall study start date | 15/07/2008 |
| Completion date | 01/06/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | Total recruited 246 (target was 400) |
| Total final enrolment | 246 |
| Key inclusion criteria | 1. Both male and female patients (no specific age limit) 2. Radiologically proven colonic obstruction of left colon/upper rectum presumed secondary to a carcinoma 3. Patient considered sufficiently fit for surgery if allocated |
| Key exclusion criteria | 1. Patients with signs of peritonitis and/or perforation 2. Patients with right iliac fossa tenderness and features of incipient caecal perforation 3. Patients with obstruction in the rectum that may require neoadjuvant therapy (i.e. tumours in the mid or lower rectum) 4. Patients who are unfit for surgical treatments or refuse surgical treatment 5. Pregnant patients |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Addenbrooke’s Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom
BD9 6RJ
United Kingdom
Darent Valley Hospital
Dartford
DA2 8DA
United Kingdom
DA2 8DA
United Kingdom
Derby Hospitals NHS Foundation Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Gartnavel General Hospital
Glasgow
G12 0YN
United Kingdom
G12 0YN
United Kingdom
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom
G4 0SF
United Kingdom
Imperial College Healthcare NHS Trust
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Ipswich Hospital
Ipswich
IP4 5PD
United Kingdom
IP4 5PD
United Kingdom
James Paget University Hospital
Norwich
NR31 6LA
United Kingdom
NR31 6LA
United Kingdom
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
King’s College Hospital
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
TA1 5DA
United Kingdom
Nevill Hall Hospital
Abergavenny
NP7 7EG
United Kingdom
NP7 7EG
United Kingdom
North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
North Devon District Hospital
Barnstaple
EX31 4JB
United Kingdom
EX31 4JB
United Kingdom
Northern General Hospital
Sheffield
S5 7AU
United Kingdom
S5 7AU
United Kingdom
North West London Hospitals NHS Trust
London
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Princess of Wales Hospital
Bridgend
CF31 1RQ
United Kingdom
CF31 1RQ
United Kingdom
Queen Elizabeth Hospital
Birmingham
B15 2GW
United Kingdom
B15 2GW
United Kingdom
Queen’s Hospital
Romford
RM7 0AG
United Kingdom
RM7 0AG
United Kingdom
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Raigmore Hospital
Inverness
IV2 3UJ
United Kingdom
IV2 3UJ
United Kingdom
Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom
RG1 5AN
United Kingdom
Royal Cornwall Hospital
Truro
TR1 3LQ
United Kingdom
TR1 3LQ
United Kingdom
Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom
BL4 0JR
United Kingdom
Royal Devon and Exeter Hospital
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
DY1 2HQ
United Kingdom
Salford Royal Hospital
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Scarborough General Hospital
Scarborough
YO12 6QL
United Kingdom
YO12 6QL
United Kingdom
Scunthorpe General Hospital
Scunthorpe
DN15 7BH
United Kingdom
DN15 7BH
United Kingdom
St James’s University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
The Mid Yorkshire Hospitals NHS Trust
Wakefield
WF1 4DG
United Kingdom
WF1 4DG
United Kingdom
Ulster Hospital
Belfast
BT16 1RH
United Kingdom
BT16 1RH
United Kingdom
University Hospital Coventry & Warwickshire
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
University Hospital Of North Durham
Durham
DH1 5TW
United Kingdom
DH1 5TW
United Kingdom
University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
United Kingdom
TS19 8PE
United Kingdom
University Hospitals of Leicester NHS Trust
Leicester
LE3 9QP
United Kingdom
LE3 9QP
United Kingdom
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
EH4 2XU
United Kingdom
Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom
BA21 4AT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Research and Enterprise Services
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.bham.ac.uk |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Charity
Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 20/05/2016 | 07/05/2021 | No | No | |
| Results article | 20/08/2022 | 22/08/2022 | Yes | No |
Editorial Notes
22/08/2022: Publication reference added.
07/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
05/02/2018: The overall trial end date was changed from 31/12/2017 to 01/06/2018.
15/02/2017: Added updated link to the Plain English Summary.
23/06/2015: The following changes were made to the trial record:
1. The overall trial end date was changed from 15/07/2014 to 31/12/2017.
2. The target number of participants was changed from 400 to 246.
