The CReST2 Trial: Are uncovered or covered stents more effective in relieving bowel obstruction in people with colorectal cancer
| ISRCTN | ISRCTN54834267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54834267 |
| Secondary identifying numbers | CPMS 32120 |
- Submission date
- 13/03/2017
- Registration date
- 20/03/2017
- Last edited
- 29/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Dr Laura Magill
Public
Public
Birmingham Clinical Trials Unit
Institute of Applied Health Research
College of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 121 415 9105 |
|---|---|
| e.l.magill@bham.ac.uk |
Study information
| 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 |
| Participant information sheet | ISRCTN54834267_PIS_19Dec16_V1.pdf |
| Scientific title | CReST2: Colorectal Stenting Trial 2: uncovered vs covered endoluminal stenting in the acute management of obstructing colorectal cancer in the palliative setting |
| Study 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) |
Approved 01/02/2017, North East - Tyne & Wear South Research Ethics Committee (HRA Jarrow, Rolling Mill Road, Jarrow, NE323DT, United Kingdom; +44 (0)2071048084; hra.studyregistration@nhs.net), ref: 17/NE/0027 |
| 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 | 30/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 350; UK Sample Size: 350 |
| 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 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 centres
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Manchester
M13 9WL
United Kingdom
Southmead Hospital
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom
Chester
CH2 1UL
United Kingdom
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Queens Hospital
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Romford
RM7 0AG
United Kingdom
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Derby
DE22 3NE
United Kingdom
Nevill Hall Hospital, Abergavenny
Brecon Road
Abergavenny
NP7 7EG
United Kingdom
Abergavenny
NP7 7EG
United Kingdom
Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Blackpool
FY3 8NR
United Kingdom
University Hospitals Birmingham
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Birmingham
B15 2TH
United Kingdom
Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom
Scarborough
YO12 6QL
United Kingdom
Basingstoke and North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
The Ulster Hospital
Upper Newtownards Road
Dundonald
Belfast
BT16 1RH
United Kingdom
Dundonald
Belfast
BT16 1RH
United Kingdom
Musgrove Park Hospital, Taunton
Parkfield Drive
Taunton
TA1 5DA
United Kingdom
Taunton
TA1 5DA
United Kingdom
Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Raigmore Hospital, Inverness
Old Perth Road
Inverness
IV2 3UJ
United Kingdom
Inverness
IV2 3UJ
United Kingdom
Northern General Hospital
Herries Rd
Sheffield
S5 7AU
United Kingdom
Sheffield
S5 7AU
United Kingdom
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom
Newport
NP20 2UB
United Kingdom
Wythenshawe Hospital
Southmoor Rd
Wythenshawe
Manchester
M23 9LT
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
New Cross Hospital
Wolverhampton Rd
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Royal Stoke Hospital
Newcastle Rd
Stoke-on-Trent
ST4 6QG
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Western General Hospital
Crewe Rd S
Edinburgh
EH4 2XU
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Royal Victoria Infirmary
Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Royal Bolton Hospital
Minerva Rd
Farnworth
Bolton
BL4 0JR
United Kingdom
Farnworth
Bolton
BL4 0JR
United Kingdom
Royal Cornwall Hospital
Treliske
Truro
TR1 3LQ
United Kingdom
Truro
TR1 3LQ
United Kingdom
Sponsor information
Manchester University Hospitals NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
Cobbett House
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- 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
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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). |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | version V1 | 19/12/2016 | 20/03/2017 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN54834267_PIS_19Dec16_V1.pdf
- Uploaded 20/03/2017
Editorial Notes
29/01/2025: The overall study end date was changed from 30/04/2023 to 30/04/2025.
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.
