The role of endoluminal stenting in the acute management of obstructing colorectal cancer

ISRCTN	ISRCTN13846816
DOI	https://doi.org/10.1186/ISRCTN13846816
Protocol serial number	N/A
Sponsor	University of Birmingham (UK)
Funder	Cancer Research UK (UK)

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-relieving-a-blockage-caused-by-suspected-bowel-cancer-with-a-tube-inside-the-bowel

Contact information

Dr Laura Magill
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
Email	e.l.magill@bham.ac.uk

Prof James Hill
Scientific

Manchester University Hospitals NHS Foundation Trust
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom

Study information

Primary study design	Interventional
Study design	Open multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/06/2018

Eligibility

Participant type(s)
Age group	All
Sex	All
Target sample size at registration	246
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

United Kingdom
England
Northern Ireland
Scotland
Wales

Study participating centres

Addenbrooke’s Hospital

Cambridge
CB2 0QQ
United Kingdom

Bradford Royal Infirmary

Bradford
BD9 6RJ
United Kingdom

Darent Valley Hospital

Dartford
DA2 8DA
United Kingdom

Derby Hospitals NHS Foundation Trust

Derby
DE22 3NE
United Kingdom

Derriford Hospital

Plymouth
PL6 8DH
United Kingdom

Gartnavel General Hospital

Glasgow
G12 0YN
United Kingdom

Glasgow Royal Infirmary

Glasgow
G4 0SF
United Kingdom

Imperial College Healthcare NHS Trust

London
W2 1NY
United Kingdom

Ipswich Hospital

Ipswich
IP4 5PD
United Kingdom

James Paget University Hospital

Norwich
NR31 6LA
United Kingdom

John Radcliffe Hospital

Oxford
OX3 9DU
United Kingdom

King’s College Hospital

London
SE5 9RS
United Kingdom

Manchester Royal Infirmary

Manchester
M13 9WL
United Kingdom

Musgrove Park Hospital

Taunton
TA1 5DA
United Kingdom

Nevill Hall Hospital

Abergavenny
NP7 7EG
United Kingdom

North Bristol NHS Trust

Bristol
BS10 5NB
United Kingdom

North Devon District Hospital

Barnstaple
EX31 4JB
United Kingdom

Northern General Hospital

Sheffield
S5 7AU
United Kingdom

North West London Hospitals NHS Trust

London
HA1 3UJ
United Kingdom

Princess of Wales Hospital

Bridgend
CF31 1RQ
United Kingdom

Queen Elizabeth Hospital

Birmingham
B15 2GW
United Kingdom

Queen’s Hospital

Romford
RM7 0AG
United Kingdom

Queens Medical Centre

Nottingham
NG7 2UH
United Kingdom

Raigmore Hospital

Inverness
IV2 3UJ
United Kingdom

Royal Berkshire Hospital

Reading
RG1 5AN
United Kingdom

Royal Cornwall Hospital

Truro
TR1 3LQ
United Kingdom

Royal Bolton Hospital

Bolton
BL4 0JR
United Kingdom

Royal Devon and Exeter Hospital

Exeter
EX2 5DW
United Kingdom

Russells Hall Hospital

Dudley
DY1 2HQ
United Kingdom

Salford Royal Hospital

Salford
M6 8HD
United Kingdom

Scarborough General Hospital

Scarborough
YO12 6QL
United Kingdom

Scunthorpe General Hospital

Scunthorpe
DN15 7BH
United Kingdom

St James’s University Hospital

Leeds
LS9 7TF
United Kingdom

The Mid Yorkshire Hospitals NHS Trust

Wakefield
WF1 4DG
United Kingdom

Ulster Hospital

Belfast
BT16 1RH
United Kingdom

University Hospital Coventry & Warwickshire

Coventry
CV2 2DX
United Kingdom

University Hospital Of North Durham

Durham
DH1 5TW
United Kingdom

University Hospital of North Tees

Stockton-on-Tees
TS19 8PE
United Kingdom

University Hospitals of Leicester NHS Trust

Leicester
LE3 9QP
United Kingdom

Western General Hospital

Edinburgh
EH4 2XU
United Kingdom

Yeovil District Hospital

Yeovil
BA21 4AT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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?
Results article		20/08/2022	22/08/2022	Yes	No
Abstract results		20/05/2016	07/05/2021	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.