Condition category
Cancer
Date applied
14/05/2008
Date assigned
27/06/2008
Last edited
23/06/2015
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

University of Birmingham
School of Health & Population Sciences
College of Medical and Dental Sciences
Public Health Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 9105
e.l.magill@bham.ac.uk

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

On 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.

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

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

Contact details of Principal Investigator:
Mr James Hill
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Length of hospital stay
2. 30-day mortality
3. Presence and duration of a stoma

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

Patient

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

University of Birmingham
Birmingham
B15 2TT
United Kingdom

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes