Condition category
Cancer
Date applied
14/05/2008
Date assigned
27/06/2008
Last edited
13/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://www.bham.ac.uk

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

Publication citations

Additional files

Editorial Notes

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.