Contact information
Type
Scientific
Primary contact
Dr Laura Magill
ORCID ID
Contact details
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
+44 (0)121 415 9105
e.l.magill@bham.ac.uk
Type
Scientific
Additional contact
Mr James Hill
ORCID ID
Contact details
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The role of endoluminal stenting in the acute management of obstructing colorectal cancer
Acronym
CReST
Study hypothesis
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
Oxford Research Ethics Committee B, 22/10/2008, ref: 08/H0605/90
Study design
Open multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 ischarge 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 trial start date
15/07/2008
Overall trial end date
31/12/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Mixed
Age group
All
Gender
Both
Target number of participants
Total recruited 246 (target was 400)
Participant 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
Recruitment start date
01/03/2009
Recruitment end date
31/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke’s Hospital
CB2 0QQ
Trial participating centre
Bradford Royal Infirmary
BD9 6RJ
Trial participating centre
Darent Valley Hospital
DA2 8DA
Trial participating centre
Derby Hospitals NHS Foundation Trust
DE22 3NE
Trial participating centre
Derriford Hospital
PL6 8DH
Trial participating centre
Gartnavel General Hospital
G12 0YN
Trial participating centre
Glasgow Royal Infirmary
G4 0SF
Trial participating centre
Imperial College Healthcare NHS Trust
W2 1NY
Trial participating centre
Ipswich Hospital
IP4 5PD
Trial participating centre
James Paget University Hospital
NR31 6LA
Trial participating centre
John Radcliffe Hospital
OX3 9DU
Trial participating centre
King’s College Hospital
SE5 9RS
Trial participating centre
Manchester Royal Infirmary
M13 9WL
Trial participating centre
Musgrove Park Hospital
TA1 5DA
Trial participating centre
Nevill Hall Hospital
NP7 7EG
Trial participating centre
North Bristol NHS Trust
BS10 5NB
Trial participating centre
North Devon District Hospital
EX31 4JB
Trial participating centre
Northern General Hospital
S5 7AU
Trial participating centre
North West London Hospitals NHS Trust
HA1 3UJ
Trial participating centre
Princess of Wales Hospital
Bridgend
CF31 1RQ
Trial participating centre
Queen Elizabeth Hospital
Birmingham
B15 2GW
Trial participating centre
Queen’s Hospital
Romford
RM7 0AG
Trial participating centre
Queens Medical Centre
NG7 2UH
Trial participating centre
Raigmore Hospital
IV2 3UJ
Trial participating centre
Royal Berkshire Hospital
RG1 5AN
Trial participating centre
Royal Cornwall Hospital
TR1 3LQ
Trial participating centre
Royal Bolton Hospital
BL4 0JR
Trial participating centre
Royal Devon and Exeter Hospital
EX2 5DW
Trial participating centre
Russells Hall Hospital
DY1 2HQ
Trial participating centre
Salford Royal Hospital
M6 8HD
Trial participating centre
Scarborough General Hospital
YO12 6QL
Trial participating centre
Scunthorpe General Hospital
DN15 7BH
Trial participating centre
St James’s University Hospital
LS9 7TF
Trial participating centre
The Mid Yorkshire Hospitals NHS Trust
WF1 4DG
Trial participating centre
Ulster Hospital
BT16 1RH
Trial participating centre
University Hospital Coventry & Warwickshire
CV2 2DX
Trial participating centre
University Hospital Of North Durham
DH1 5TW
Trial participating centre
University Hospital of North Tees
TS19 8PE
Trial participating centre
University Hospitals of Leicester NHS Trust
LE3 9QP
Trial participating centre
Western General Hospital
EH4 2XU
Trial participating centre
Yeovil District Hospital
BA21 4AT
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Research and Enterprise Services
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
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.
Intention to publish date
13/06/2017
Participant level data
Other
Results - basic reporting
Publication summary