CReST2: Colorectal Stenting Trial 2: uncovered vs covered endoluminal stenting in the acute management of obstructing colorectal cancer in the palliative setting
Trial Overview
| Acronym | CReST2 |
|---|---|
| Number | ISRCTN54834267 |
| Protocol Link | https://www.journalslibrary.nihr.ac.uk/programmes/hta/142802/#/documentation |
| Public Trial Registry Link | http://www.isrctn.com/ISRCTN54834267 |
| Status | Open/recruiting |
| Category | Colorectal Cancer - All |
| Treatment Course | Adjuvant, palliative or post-op |
Trial Description
| Stenting now has an accepted role in the palliative care of people with colorectal cancer. However, there is little evidence of which type of stent is best to use - covered or uncovered. To provide robust evidence, CReST2 is a blinded, randomised controlled trial. 350 patients will be randomised to receive either a covered or uncovered stent to relieve bowel obstruction due to colorectal cancer. |
Chief Investigator
|
Professor James Hill Consultant General and Colorectal Surgeon |
| Profile Link |
Lead Centre
|
Central Manchester University Hospitals NHS Foundation Trust: Manchester Royal Infirmary Oxford Road Manchester M13 9WL United Kingdom |
| Website |
Collaboration and Funding
Collaborative Sites
| 1. Manchester Royal Infirmary Oxford Road Manchester M13 9WL United Kingdom |
| 2. Southmead Hospital Southmead Road Westbury-on-Trym Bristol BS10 5NB United Kingdom |
| 3. Countess of Chester Hospital Liverpool Road Chester CH2 1UL United Kingdom |
| 4. Bradford Royal Infirmary Duckworth Lane Bradford BD9 6RJ United Kingdom |
| 5. Queens Hospital Rom Valley Way Romford RM7 0AG United Kingdom |
| 6. Addenbrookes Hospital Hills Road Cambridge CB2 0QQ United Kingdom |
| 7. Royal Derby Hospital Uttoxeter Road Derby DE22 3NE United Kingdom |
| 8. Nevill Hall Hospital, Abergavenny Brecon Road Abergavenny NP7 7EG United Kingdom |
| 9. Blackpool Victoria Hospital Whinney Heys Road Blackpool FY3 8NR United Kingdom |
| 10. University Hospitals Birmingham Mindelsohn Way Birmingham B15 2TH United Kingdom |
| 11. Scarborough General Hospital Woodlands Drive Scarborough YO12 6QL United Kingdom |
| 12. Basingstoke and North Hampshire Hospital Aldermaston Road Basingstoke RG24 9NA United Kingdom |
| 13. The Ulster Hospital Upper Newtownards Road Dundonald Belfast BT16 1RH United Kingdom |
| 14. Musgrove Park Hospital Taunton Parkfield Drive Taunton TA1 5DA United Kingdom |
| 15. Macclesfield District General Hospital Victoria Road Macclesfield SK10 3BL United Kingdom |
| 16. Raigmore Hospital Inverness Old Perth Road Inverness IV2 3UJ United Kingdom |
| 17. Northern General Hospital Herries Road Sheffield S5 7AU United Kingdom |
| 18. Royal Gwent Hospital Cardiff Road Newport NP20 2UB United Kingdom |
| 19. Whythenshawe Hospital Southmoor Road Manchester M23 9LT United Kingdom |
| 20. New Cross Hospital Wolverhampton Road, Heath Town Wolverhampton WV10 0QP United Kingdom |
Funding Sponsors
| 1. National Institute for Health Research (NIHR) CReST2 is funded by the NIHR Health Technology Programme. |
Additional Information
Full Research Summary| Objective: | Primary Objectives: To determine if: The quality of life for palliative colorectal cancer patients requiring a stent is dependent on whether the stent is covered or uncovered The efficacy of the stenting procedure is dependent on whether the stent is uncovered or covered. Secondary Objectives: To determine: If the technical success rate and the incidence of stent-related complications (perforation, blockage, migration) are different between covered and uncovered stents The rate of re-interventions in each arm Whether the stent type used affects the stoma rate If the stent type used impacts on overall survival The cost effectiveness of implementing covered stents compared to uncovered stents. |
| Aim: | The aim of the CReST2 trial is to determine if the use of covered stents for palliative patients with obstructing colonic cancer where the intention is to leave the stent in situ, will result in an improved Quality of Life when compared to the use of uncovered stents. |
| Methods: | CReST2 is a phase III randomised controlled trial. 350 patients will be randomised in a 1:1 ratio between covered and uncovered stents. It is a blinded study and only the person inserting the stent will know the randomised allocation. The primary outcomes measures are Quality of Life at 3 months (measured using QLQ-C30, CLQ-CR29 and EQ-5D-5L) and stent patency at 6 months. Patients will be followed up for two years post randomisation. |
| Reason for International Trial: | To maximise recruitment opportunities Ensure trial results are relevant to international health care providers. |