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
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number CPMS 32120
Sponsor Manchester University Hospitals NHS Foundation Trust
Funder National Institute for Health Research
Submission date
13/03/2017
Registration date
20/03/2017
Last edited
23/09/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Laura Magill
Public

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

Study information

Primary study designInterventional
Study designRandomised; Interventional; Design type: Treatment, Device, Complex Intervention, Surgery
Secondary study designRandomised controlled trial
Participant information sheet ISRCTN54834267_PIS_19Dec16_V1.pdf
Scientific titleCReST2: Colorectal Stenting Trial 2: uncovered vs covered endoluminal stenting in the acute management of obstructing colorectal cancer in the palliative setting
Study acronymCReST2
Study objectivesThe 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

Health condition(s) or problem(s) studiedColorectal cancer
InterventionThe 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date30/04/2025

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration350
Total final enrolment377
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment16/06/2017
Date of final enrolment30/04/2022

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Northern Ireland
  • Scotland
  • Wales

Study participating centres

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Southmead Hospital
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Queens Hospital
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Nevill Hall Hospital, Abergavenny
Brecon Road
Abergavenny
NP7 7EG
United Kingdom
Blackpool Victoria Hospital
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
University Hospitals Birmingham
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom
Basingstoke and North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
The Ulster Hospital
Upper Newtownards Road
Dundonald
Belfast
BT16 1RH
United Kingdom
Musgrove Park Hospital, Taunton
Parkfield Drive
Taunton
TA1 5DA
United Kingdom
Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Raigmore Hospital, Inverness
Old Perth Road
Inverness
IV2 3UJ
United Kingdom
Northern General Hospital
Herries Rd
Sheffield
S5 7AU
United Kingdom
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom
Wythenshawe Hospital
Southmoor Rd
Wythenshawe
Manchester
M23 9LT
United Kingdom
New Cross Hospital
Wolverhampton Rd
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Royal Stoke Hospital
Newcastle Rd
Stoke-on-Trent
ST4 6QG
United Kingdom
Western General Hospital
Crewe Rd S
Edinburgh
EH4 2XU
United Kingdom
Royal Victoria Infirmary
Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
United Kingdom
Royal Bolton Hospital
Minerva Rd
Farnworth
Bolton
BL4 0JR
United Kingdom
Royal Cornwall Hospital
Treliske
Truro
TR1 3LQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
IPD sharing planThe 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?
Results article 02/09/2025 23/09/2025 Yes No
HRA research summary 28/06/2023 No No
Participant information sheet version V1 19/12/2016 20/03/2017 No Yes
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Additional files

ISRCTN54834267_PIS_19Dec16_V1.pdf
Uploaded 20/03/2017

Editorial Notes

23/09/2025: Publication reference and total final enrolment added.
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.

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