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Upper Gastrointestinal Disorders clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03641118 Recruiting - Clinical trials for Hepatobiliary Cancer

Sarcopenia and Physiology Assessments in Cancer Patients

Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Primary Aim: To establish a reliable relationship between oxygen uptake (VO2) at estimated lactate threshold (AT) and CT-derived body composition measurments (e.g. muscle radiation attenuation), and to relate these to post-operative outcomes (i.e. post-operative complications or 1-year survival) in cohort of upper (UGI) and lower (LGI) gastrointestinal and hepatobiliary (HPB) cancer patients undergoing surgery +/- cancer therapies. Rationale:Objectively measured reduction of muscle radiation attenuation (i.e. Computed Tomography (CT) measured indices of muscle wasting) coupled with reduced physical fitness (measured objectively using Cardiopulmonary Exercise Testing (CPET)) will result in worse post-operative surgical outcome and reduced survival. Trial Design: Observational Sample size: See statistical analyses section for individual cohort power calculations Inclusion Criteria: Male or female patients, aged over 18 years old with UGI, LGI or HPB cancer undergoing surgery +/- cancer therapies; WHO performance status 0-2. Exclusion Criteria: Patients will be excluded if they have surgery for benign disease, a diagnosis of inflammatory bowel disease, patients physically unable to perform a CPET on a cycle ergometer, patients having no surgery performed or interim emergency surgery, patients lacking complete in-hospital morbidity and survival data. Primary Trial Endpoints: UGI patients - 2 year overall survival, LGI and HPB patients - post-operative complications (Calvien-Dindo and Composite Endpoint in pancreaticoduodenectomy)