Best analgesia control in pancreatic adenocarcinoma study: justification and feasibility of a randomised trial of early EUS-CPN versus standard care—a prospective observational study (The BAC-PAC study)

Abstract

Abstract Introduction Limited and conflicting trial data is available on the efficacy of Endoscopic Ultrasound-guided Coeliac Plexus Neurolysis (EUS-CPN). This study aimed to assess the feasibility, justification and to inform design considerations of a randomised trial of early EUS-CPN versus standard care. Methods This was a questionnaire-based prospective observational study of patients with inoperable pancreatic adenocarcinoma who were self-reporting their performance status, pain levels, analgesic use, quality of life (QoL) and healthcare resource use, on a monthly basis. Results Over a total period of twelve months 143 patients were screened for eligibility, of which 56 met the criteria. In total, 12 (21%) patients were recruited. The median survival from the first record of pain was 5.2 (IQR 2.46–5.9) months. In total, 80% of the questionnaires were completed. The median Visual Analogue Score for pain was 2.6 (0.8–5.1) and the median daily morphine dose was 36 (20–48) mg. Discussion Recruitment rates remained low throughout this study. Despite these limitations, overall, this study supports the justification of trial administering endoscopic analgesia. However, uncertainties remain with regards to its feasibility. In a future trial, data collection procedures need to minimise burden to patients. Further observational research with a larger sample size, longer follow-up and refined procedures is required.