Much progress has been made in trial recruitment to GI and hepatology trials across the UK and many Trusts have benefitted from investment by comprehensive local research networks (CLRNs), with funding for research nurses being the most common resource provided.

A key aim of the UK Clinical Research Network is to double recruitment to clinical trials in five years, and in GI there has been significant progress towards this with recruitment of over 9000 patients in 09/10, a 30% increase compared to the previous year. Another key aim is to increase the number of trials recruiting to target, and performance on this measure has also improved significantly, from 69% in May 2009 to 83% in April 2010.

The GI specialty group is keen that:

• interested clinicians are encouraged to recruit patients and also have access to the NIHR CCRN infrastructural support.
• Any blocks to trial recruitment are highlighted: These can be fed to your local CLRN GI specialty lead(see link below) or to Stuart Bloom (luminal GI) or Steve Ryder (Hepatology).

Anyone wishing to become involved in clinical trials will need to attend an on-line or in-person course on GCP (Good Clinical Practice). These are usually free from your local R&D Dept. Also see useful links below. Advice on trial set-up can be obtained from trial coordinators and local R&D teams. Most CLRN's have a lead for GI and Hepatology, and these individuals can advise on commercial studies and CLRN support funding. To find your Lead click here.

Barrett’s Oesophagus Surveillance Study

The aim of the study is to see whether endoscopic surveillance is better than no endoscopic surveillance for the prevention of early mortality in patients diagnosed with Barrett’s oesophagus. The study randomises patients to receive a standard upper gastrointestinal endoscopy with biopsy every two years for 10 years or endoscopy at the time of need (no protocol endoscopic surveillance). All patients will receive a bi-annual postal questionnaire to record their symptoms and other health related data (administered by the centre. Patients will be recruited over 2 years and followed up for a further 10 years. The chief investigator is Prof Hugh Barr ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ).

A multicentre trial of infliximab and ciclosporin in steroid-resistant active severe colitis. There was an initial pilot phase which has gone well. Six centres have full approval and will start recruitment in March. The recruitment target is 480 patients, and the plan is to do this from at least 40 sites across the UK. If you would like more information please email This e-mail address is being protected from spambots. You need JavaScript enabled to view it , or contact the trial coordinator, Anne Seagrove, directly on 01792 513411, email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Update 1/6/2010: Recruitment to date is slower than expected. The lessons we have learned in setting up this trial include a realisation that research governance approvals can take six months to come through however keen colleagues are to start, and a need to think ahead – for example to ensure at an early stage that all research staff are GCP trained, and not to wait until the trial is about to start to seek this. Six sites have full R&D approvals and have been trained to start the study. Many others are about to come on stream. There are still opportunities for other sites to join us. We wish to recruit patients rapidly, mindful of the urgent need to get answers to the main research question – which treatment is more clinically effective in terms of quality of life at 2 years? Please contact us ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ) if you wish to join the study. If you are already signed up – please keep the pressure on!

A multicentre RCT of the efficacy of 6-MP in the prevention of recurrence of Crohn’s Disease after ileo-colonic or small bowel resection. Patients are recruited within 3 months of surgery. Patients will receive 6MP or placebo for up to 3 years (156 weeks) and attend 12 study visits during this time.

STOPAH (steroids or pentoxifylline in Alcoholic Hepatitis) is a multicentre UK trial funded by NIHR. This is a vital study in UK hepatology looking to prove the role of steroids or pentoxyfilline versus placebo in the treatment of a condition which is increasingly common in the UK. Patients with DF>32 are eligible and the study is designed to be pragmatic with few exclusions to treatment. Primary outcome is 30-day mortality but with follow-up to a year.
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Update 1/6/2010: This is currently in set-up and anyone interested should contact the trial coordinator. Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it (chief investigator) , This e-mail address is being protected from spambots. You need JavaScript enabled to view it (clinical trial coordinator).