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)

BJC Rep. 2023 Sep 18;1(1):14. doi: 10.1038/s44276-023-00013-x.

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.