Condition category
Cancer
Date applied
13/03/2017
Date assigned
20/03/2017
Last edited
16/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Dr Laura Magill

ORCID ID

Contact details

Birmingham Clinical Trials Unit
Institute of Applied Health Research
College of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 121 415 9105
e.l.magill@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32120

Study information

Scientific title

CReST2: Colorectal Stenting Trial 2: uncovered vs covered endoluminal stenting in the acute management of obstructing colorectal cancer in the palliative setting

Acronym

CReST2

Study hypothesis

The aim of this study is to assess whether covered stents used for palliative patients with obstructing colorectal cancer, will result in an improved Quality of Life when compared to uncovered stents.

Ethics approval

North East - Tyne & Wear South Research Ethics Committee, 01/02/2017, ref: 17/NE/0027

Study design

Randomised; Interventional; Design type: Treatment, Device, Complex Intervention, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Cancer, Primary sub-specialty: Colorectal Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs

Intervention

The trial will compare covered with uncovered colonic stents. The trial is blinded and only the person inserting the stent will know the allocation. Randomisation will be provided by a secure online randomisation system at the coordinating centre (BCTU) and the allocation will be sent to the person inserting the stent.

The stents used in the trial are existing, commercially available products which are licensed and CE marked. Participating sites can use the stent of their choice. Stents will be inserted as a joint endoscopic/fluoroscopic procedure by individuals experienced in performing colonic stenting.

The target population are patients treated with palliative intent. Therefore, the stents will remain in-situ, unless there are complications requiring further interventions. Following stent insertion the site’s standard care pathways will be followed and patients will be treated symptomatically.

Patients will be followed-up at their usual out-patient appointments and data collected for a total of 24 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Quality of Life is measured using the EORTC QLQ C30 and CR29; EQ-5D-5L questionnaires at baseline and 3 months post-stenting (30 days for patients dying before 3 months)
2. Stent patency is measured using Stent Follow Up Form (completed by site) at 6 months post-stenting

Secondary outcome measures

Current secondary outcome measures as of 12/01/2018:
1. Stenting success rate is measured by Stent Insertion Form (completed by site) at the time of stent insertion
2. Time to onset of stent related complications in the short term, intermediate term and long term is measured by Stent Follow Up Forms (completed by site) at 30 days post stenting, 1-3 months post stenting and 3-12 months post stenting
3. Stent related complication rates of patients on chemotherapy is measured by Stent Follow Up Form at 12 months
4. Cumulative frequency and duration of stoma formation is measured by Stent Follow Up Forms (as above), Intraoperative Form up to 12 months
5. Overall survival is measured by ONS data at 12 months. Stent Follow Up Forms record date of death (if applicable). However, we also obtain mortality data from ONS.
6. Cost effectiveness (cost per QALY) is measured by EQ-5D-5L; trial specific forms also collect some data which will be used to assess resource use

Previous secondary outcome measures:
1. Stenting success rate is measured by Stent Insertion Form (completed by site) at the time of stent insertion
2. Time to onset of stent related complications in the short term, intermediate term and long term is measured by Stent Follow Up Forms (completed by site) at 30 days post stenting, 1-3 months post stenting and 3-12 months post stenting
3. Stent related complication rates of patients on chemotherapy is measured by Stent Follow Up Form at 12 months
4. Cumulative frequency and duration of stoma formation is measured by Stent Follow Up Forms (as above), Intraoperative Form up to 12 months
5. Overall survival is measured by ONS data at 12 months. Stent Follow Up Forms record date of death (if applicable). However, we also obtain mortality data from ONS.
6. Cost effectiveness (cost per QALY) is measured by all trial specific forms collect some data to be used to assess resource use (i.e. Stent Insertion, Hospital Discharge Form, Follow Up Forms, Intraoperative Form) at 24 months

Overall trial start date

01/07/2016

Overall trial end date

30/06/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 16 year and over
2. Patients presenting with obstructing colorectal cancer, which is to be treated with palliative intent
3. Patients able and willing to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 350; UK Sample Size: 350

Participant exclusion criteria

1. Patients with impending or established perforation of the colon
2. Patients with low rectal cancer, i.e. a carcinoma in the lower third of the rectum
3. Patients being treated or considered for treatment with antiangiogenic drugs (e.g. bevacizumab)
4. Pregnant patients

Recruitment start date

16/06/2017

Recruitment end date

31/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Queens Hospital
Rom Valley Way
Romford
RM7 0AG
United Kingdom

Trial participating centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Nevill Hall Hospital, Abergavenny
Brecon Road
Abergavenny
NP7 7EG
United Kingdom

Trial participating centre

Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

University Hospitals Birmingham
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom

Trial participating centre

Basingstoke and North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

The Ulster Hospital
Upper Newtownards Road Dundonald
Belfast
BT16 1RH
United Kingdom

Trial participating centre

Musgrove Park Hospital, Taunton
Parkfield Drive
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

Raigmore Hospital, Inverness
Old Perth Road
Inverness
IV2 3UJ
United Kingdom

Sponsor information

Organisation

Manchester University Hospitals NHS Foundation Trust

Sponsor details

Trust Headquarters
Cobbett House
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The timing of the first main analysis is two years after the final patient enters the study (approximately January 2022). The final paper will be submitted to a high-impact peer reviewed journal.
A trial website is in preparation (www.trials.bham.ac.uk/CReST2).
CReST2 is represented on the ACPGBI website (Association of Coloproctology of GB and Ireland).

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

31/01/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/01/2018: Internal review. 12/01/2018: The sponsor name has changed from the Central Manchester University Hospitals NHS Foundation Trust to Manchester University Hospitals NHS Foundation Trust. The recruitment start date has been updated from 01/04/2017 to 16/06/2017. The secondary outcome measures have been updated. The trial participant centres have been added 16/10/2017: Internal review.