OBJECT
Research type
Research Study
Full title
OBJECT: Observational study of the relationship between obstructive jaundice and physical fitness: The effect of obstructive jaundice and non-surgical biliary drainage on physical fitness, immunity, inflammation, quality of life and surgical outcomes in patients with obstructive jaundice.
IRAS ID
179926
Contact name
Mark Edwards
Contact email
Sponsor organisation
University Hospitals Southampton
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Over 10,000 people develop cancers of the pancreas and bile system each year in the UK. Long term outcomes after surgery for these conditions are poor, and we need to focus on ways of improving the care of these patients. Many patients present with jaundice caused by obstruction of the bile system by a cancerous tumour. This is termed "obstructive jaundice" and can prevent the normal function of many body systems, putting patients at increased risk of complications or death after the major surgery. Although the obstruction may be relieved before surgery by a stent to open up the bile duct, evidence remains inconclusive on whether this is beneficial.
Multiple studies in patients undergoing major surgery have shown that a key predictor for poor postoperative outcomes is patients’ preoperative physical fitness. This is best assessed objectively by formal cardiopulmonary exercise testing (CPET). Small studies have suggested that jaundice may itself be a cause of reduced physical fitness, however this area has not been adequately explored. The strength of the proposed relationship between jaundice and poor physical fitness has not been defined, and it unclear whether reversing jaundice through biliary stenting will improve physical fitness.
The core hypotheses of this study are that obstructive jaundice is associated with worse physical fitness, and that reversing the jaundice through pre-operative biliary stenting will lead to an improvement in physical fitness. We aim to address these hypotheses with this observational study, comprised of a cohort analysis and longitudinal study tracking changes in physical fitness in patients undergoing biliary drainage procedures. Secondary outcomes will examine possible relationships between obstructive jaundice – and its treatment – and multi-organ function, inflammation and immunity and outcomes after definitive surgery.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0249
Date of REC Opinion
2 Oct 2015
REC opinion
Further Information Favourable Opinion