CReST2 is an additional study building on the success of CReST – the world’s largest stenting trial of large bowel obstruction! The randomised trial is testing the stated hypothesis of ‘Uncovered vs covered endoluminal stenting in the acute management of obstructing colorectal cancer in the palliative setting’. Randomisation is provided via a secure online system, at the coordinating centre (BCTU), where the allocation is sent to the clinician inserting the stent.

The study is a five-year (2016-2021) NIHR funded multi centre trial, with the aim of recruiting 350 patients over a 3-year period, while monitoring internal feasibility to assess the rate of recruitment and clinician equipoise in the adoption of stent type. Stents will be inserted in a joint endoscopic and fluoroscopic procedure.

Timescales for the first main analysis of trial results is around two years from the final patient entering the study. The final results paper will be submitted to a high-impact peer reviewed journal. The anticipated publish date is 31/01/2022.

CReST2 Trial Rationale:

Colorectal cancer is a frequent cause of cancer mortality; ranking the second most common cause of cancer death, in the UK. On average, 15% of patients with colorectal cancer present with a bowel obstruction each year. Coupled with this, patient life expectancy has increased; thus, more patients living longer with stents in situ. –  Therefore, choosing the right stent design is imperative to ensure maximum quality of life. In the notion of stent design, the rate of reintervention may also be affected dependent on the stent style chosen, and therefore a reflection in cost.

Two designs of stent are commonly used in the UK today. – Nine out of ten stents placed to relieve an obstruction in patients with colorectal cancer are uncovered, while the remaining stents used are covered. The CReST2 clinical trial has been formulated as currently there is insufficient evidence to draw a conclusion on whether uncovered or covered metal stents are best practice when treating patients with colorectal cancer obstruction. The outcome of the trial will determine which stent type is the most efficacious in improving the quality of life for patients with bowel obstruction arising from colorectal cancer.

Trial Objectives:

The research has primary and secondary objectives, with the former determining if covered or uncovered stents improve the quality of life for palliative colorectal cancer patients who require stenting. While also ascertaining if the efficacy of the stenting procedure is dependent on the stent design – covered or uncovered.

The latter is to identify if the technical success rate and occurrence of stent-related complications – perforation, blockage, migration – differ between covered and uncovered stents. Furthermore, establishing the endoscopic re-intervention rate in both stent types. While also determining whether the stent design placed affects the stoma rate and impacts on overall patient survival. Underlined with the overarching objective, to measure cost effectiveness when implementing covered stents; compared to uncovered stents.

Outcome measures for CReST2 trial:

There are both Primary and Secondary outcome measures for the colorectal trial. The primary consists of, patient quality of life 3 months post-stenting (30 days for patients dying before 3 months), evaluated by the QLQ-C30 questionnaire, and compared with the baseline. While also, measuring stent patency post 6 months stenting.

The secondary outcome measures are to identify the stenting success in both stent designs, as defined by clinical relief of bowel obstruction. Furthermore, the duration to potential onset of short, intermediate and long-term* stent related complications – with the inclusion of patient complication rates undergoing chemotherapy. Bearing in mind the cumulative frequency and duration of stoma formation for both uncovered and covered stents. Finally, overshadowing the above, patient survival at 1-year post-stenting and cost effectiveness – outlined via the outcome measure ‘cost per quality adjusted life year’. Coupled with the quality of Life at 3 months, measured using the QLQ-CR29 Disease Specific Module for Colorectal Cancer.

There are both Primary and Secondary outcome measures for the colorectal trial. The primary consists of, patient quality of life 3 months post-stenting (30 days for patients dying before 3 months), evaluated by the QLQ-C30 questionnaire, and compared with the baseline. While also, measuring stent patency post 6 months stenting.

The secondary outcome measures are to identify the stenting success in both stent designs, as defined by clinical relief of bowel obstruction. Furthermore, the duration to potential onset of short, intermediate and long-term* stent related complications – with the inclusion of patient complication rates undergoing chemotherapy. Bearing in mind the cumulative frequency and duration of stoma formation for both uncovered and covered stents. Finally, overshadowing the above, patient survival at 1-year post-stenting and cost effectiveness – outlined via the outcome measure ‘cost per quality adjusted life year’. Coupled with the quality of Life at 3 months, measured using the QLQ-CR29 Disease Specific Module for Colorectal Cancer.

** Time frames defined as:

  • Short (30 days),
  • Intermediate (1-3 months)
  • Long-term (3-12 months)

For further information and updates on CReST2 trial outcomes visit the ISRCTN website.

Criteria:

CReST2 Inclusion Criteria:

All consented patients involved in the trial will be aged 16 or over, with obstructing colorectal cancer – to be treated with palliative intent; they will suffer from one, or a combination, of the following:

  • Unresectable local disease
  • Unresectable metastatic disease
  • A combination of the above
  • Considered unfit for surgery

CReST2 Exclusion Criteria:

Patients with the below criteria will not partake in the trial…

  • Impending or established perforation of the colon
  • Patients with low rectal cancer (i.e. carcinoma in the lower third of the rectum)
  • Patients being treated or considered for treatment with antiangiogenic drugs (e.g. bevacizumab)
  • Pregnant patients

CReST2 Study Design:

The trial is a blinded, multicentre, Phase III, randomised controlled trial, with a sample size of 350.

CReST2 Study Design

Source: University Of Birmingham

Is your hospital participating in CReST2?

We are now offering a promotional price on stents available in the CReST2 trial!

Our colorectal stent portfolio consists of market leading, handmade, covered and uncovered stents for a variety of indications suited to the CReST2 trial.

View our offer and stent information in further detail below.

CReST2 Offer!

Get in touch with your local Product Specialist for more information 

or alternatively call our head office on 01845 526660!

How our stents are manufactured…

Sources:

Want to Hear More From Diagmed?

Keep up to date with all of the latest news and information from Diagmed Healthcare.

SIGN UP TO OUR MAILING LIST HERE