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

Funding Sponsors

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.

Trial Details

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

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

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Trial Details

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

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

About ESCP

News & Events

Education

Research

Members

Contact Us

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