Submission date
13/03/2017
Registration date
20/03/2017
Last edited
02/02/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
✓ Prospectively registered
? Protocol not yet added
? SAP not yet added
? Results not yet added and study completed for 1-2 years
? Raw data not yet added
✓ Study completed

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-different-types-of-stent-to-treat-bowel-obstruction-in-people-with-bowel-cancer

Study website

www.birmingham.ac.uk/CReST2

Contact information

Type

Public

Contact name

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/CTIS number

IRAS 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(s)

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

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

See additional files

Condition

Colorectal cancer

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

Primary outcome measure

1. Quality of Life is measured using the EORTC QLQ C30 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

Secondary outcome measures as of 01/10/2018:
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
7. Quality of Life at 3 months measured using the QLQ-CR29 Disease Specific Module for Colorectal Cancer

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 study start date

01/07/2016

Overall study end date

30/04/2023

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Sex

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

30/04/2022

Locations

Countries of recruitment

England, Northern Ireland, Scotland, United Kingdom, Wales

Study participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Study participating centre

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

Study participating centre

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

Study participating centre

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Study participating centre

Queens Hospital
Rom Valley Way
Romford
RM7 0AG
United Kingdom

Study participating centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Study participating centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Study participating centre

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

Study participating centre

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

Study participating centre

University Hospitals Birmingham
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom

Study participating centre

Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom

Study participating centre

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

Study participating centre

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

Study participating centre

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

Study participating centre

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

Study participating centre

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

Study participating centre

Northern General Hospital
Herries Rd
Sheffield
S5 7AU
United Kingdom

Study participating centre

Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Study participating centre

Wythenshawe Hospital
Southmoor Rd
Wythenshawe
Manchester
M23 9LT
United Kingdom

Study participating centre

New Cross Hospital
Wolverhampton Rd
Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Study participating centre

Royal Stoke Hospital
Newcastle Rd
Stoke-on-Trent
ST4 6QG
United Kingdom

Study participating centre

Western General Hospital
Crewe Rd S
Edinburgh
EH4 2XU
United Kingdom

Study participating centre

Royal Victoria Infirmary
Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
United Kingdom

Study participating centre

Royal Bolton Hospital
Minerva Rd
Farnworth
Bolton
BL4 0JR
United Kingdom

Study participating centre

Royal Cornwall Hospital
Treliske
Truro
TR1 3LQ
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
England
United Kingdom

Sponsor type

Hospital/treatment centre

Website

ROR

https://ror.org/00he80998

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Current publication and dissemination plan as of 02/02/2022:
The timing of the first main analysis is three years after the final patient enters the study (approximately March 2023). The final paper will be submitted to a high-impact peer-reviewed journal.
The trial website is in available (www.birmingham.ac.uk/CReST2).
CReST2 is represented on the ACPGBI website (Association of Coloproctology of GB and Ireland).


Previous 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.birmingham.ac.uk/CReST2).
CReST2 is represented on the ACPGBI website (Association of Coloproctology of GB and Ireland).

Intention to publish date

31/03/2023

Individual participant data (IPD) sharing plan

The current data sharing plans for the current study are unknown and will be made available at a later date.

IPD sharing plan summary

Data sharing statement to be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V1 19/12/2016 20/03/2017 No Yes
HRA research summary 28/06/2023 No No

Additional files

Editorial Notes

02/02/2022: The following changes have been made: 1. The intention to publish date has been changed from 31/01/2022 to 31/03/2023. 2. The publication and dissemination plan has been updated. 12/08/2020: The following changes were made to the trial record: 1. The recruitment resumed. 2. The recruitment end date was changed from 31/12/2019 to 30/04/2022. 3. The overall end date was changed from 30/06/2021 to 30/04/2023. 12/05/2020: Due to current public health guidance, recruitment for this study has been paused as of 09/04/2020. 26/03/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Colorectal Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs" to "Colorectal cancer" following a request from the NIHR. 01/10/2018: The following changes were made to the trial record: 1. The secondary outcome measures were updated 2. The trial website was added 3. Trial participating centres were added 13/06/2018: Cancer Research UK lay summary link added to plain English summary field 14/05/2018: Internal review. 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.