BTS 2013 Report – Transplantation clinical trials forum – Results of BTS member survey

by Maria Dalby reporting on the presentation by Dion Morton, Experimental Cancer Medicine Centre, University of Birmingham & Sir Peter John Morris, Centre for Evidence in Transplantation, Royal College of Surgeons of England.

Transplantation surgery scores amongst the lowest of all medical specialities when it comes to conducting clinical trials. Yet the experience from other surgical disciplines shows that trials can have immediate and long-lasting benefits for patient care, treatment advances and dissemination of best practice. Professor Dion Morton, specialist on colorectal cancer and director of the Birmingham University Experimental Cancer Medicine Centre, used examples from his own experience to illustrate the impact of research networks and multicentre clinical trials.

 

The Clinical Research Initiative within the Royal College of Surgeons has appointed a number of surgical speciality leads, to provide leadership and expertise in this field and to develop clinical networks through engagement with surgical trials units, charities and colleges. One such network is the West Midlands Research Collaborative, which has been set up with the aim of conducting high-quality multicentre studies. The Reduction of Surgical Site Infection using a Novel Intervention (ROSSINI) trial is the first multicentre randomised controlled trial with the aim of establishing whether the use of a wound-edge protection device in adult patients undergoing abdominal surgery may result in a lower rate of SSI. ROSSINI is carried out at 20 centres across England, and patient recruitment has far exceeded expectations (1). Another similar example is the Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS) study which is recruiting at almost double the expected rate. Professor Morton finished by pointing to the many aspects of transplantation that would lend themselves to well-designed trials, from organ preservation and risk stratification to post-operative recovery and long-term outcomes, and suggested that by taking the lead in specialist trials, a new era may be dawning for transplantation.

 

Professor Morton was followed by a session with Professor Sir Peter Morris, who outlined his wish-list for trials in the area of transplantation in the coming years. To this end, Professor Morris had also conducted an informal survey via the British Transplant Society mailing list, to gauge members’ ideas and suggestions for trials they would like to see.

 

At the top of the survey list were trials documenting different preservation techniques, including comparison of hypothermic machine perfusion (HMP) vs. cold storage, normothermic perfusion vs. HMP, and HMP with and without oxygenation in renal transplantation; normothermic vs. cold storage in liver transplantation, and the general role of stem cells to prevent ischemia-reperfusion injury. Another area where clinical trials would be welcomed by BTS members is the role of antibodies, including donor-specific antibodies and the role of interventions such as plasma exchange, anti-CD20 or proteasome inhibitor, and how to manage sensitisation. In addition, BTS members would like to see trials relating to cardiovascular risk factors, including the effect of aggressive blood pressure management and the role of aspirin, and a number of general aspects of transplantation such as psychological assessment and compliance, use of small paediatric donor organs, and real-life outcomes for live kidney donors.

 

Professor Morris’ own wish-list of trials includes definitive trials of azathioprine vs. mycophenolate mofetil, and induction vs. no induction in low-risk kidney transplant patients. There is also a need for documentation of organ preservation in DCD donors, various aspects of weaning off calcineurin inhibitor drugs, and the risks and benefits associated with generic immunosuppressive agents. Professor Morris finished by stressing the importance of having access to well-designed randomised controlled clinical trials to allow systematic reviews and meta-analyses to be conducted.

 

 

1.  Pinkney TD, Bartlett DC, Hawkins W, Mak T, Youssef H, Futaba K, et al. Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial. Trials. 2011;12:217. Epub 2011/10/06.