Optimal follow up for colorectal liver metastases and pancreas cancer
Research type
Research Study
Full title
An observational study estimating the optimal duration of follow-up in future research studies for patients suffering with colorectal liver metastases and pancreatic cancer.
IRAS ID
107108
Contact name
Kurinchi S Gurusamy
Contact email
Sponsor organisation
UCL
Research summary
Surgery (liver resection) is the treatment of choice in patients with colorectal liver metastases, but it carries a high perioperative mortality rate (3% to 4% 30-day mortality). New non-invasive treatments, such as radiofrequency ablation, have been proposed as alternative treatments. While patients undergoing such treatments suffer from few or no major complications, there are concerns about whether cancer clearance is achieved in such patients (undergoing non-invasive treatments) at the same rate as those who undergo surgery. It is generally believed that patients who survive surgery are more likely to have achieved cure than these non-invasive treatments. But this benefit of survival by surgical treatment is unlikely to be seen unless the patients have been followed up for a sufficiently long time for the disease to recur and progress. Very long periods of follow-up for at least 10 to 15 years is necessary to ensure that the accurate results of comparison between surgery and non-invasive treatments are obtained. In trials, a short follow-up may result in bias against surgery since there is higher mortality earlier in surgery, whereas very long follow-up periods can result in high costs for running a trial and delay in the adoption of treatment. Instead, one may be able to arrive at an optimal follow-up point at which further follow-up of patients is unlikely to alter the results of the comparison between surgery and non-invasive treatments (hazard ratio), and a point at which the variance in the effect estimate does not change the conclusions. The aim of this study is to determine this optimal follow-up period in trials comparing different treatments for patients with colorectal liver metastases and to assess whether it is possible to generalise the findings by expressing the optimal follow-up period in terms of proportion of patients dead or median follow-up.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0307
Date of REC Opinion
10 Oct 2013
REC opinion
Favourable Opinion