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The CReST2 Trial: Are uncovered or covered stents more effective in relieving bowel obstruction in people with colorectal cancer

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54834267
Enrollment
350
Registered
2017-03-20
Start date
2017-06-16
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer Cancer

Interventions

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 r

Sponsors

Manchester University Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactLaura Magill
e.l.magill@bham.ac.uk+44 121 415 9105

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026