Prospective observational study of prevalence, assessment and treatment of pancreatic exocrine insufficiency in patients with inoperable pancreatic malignancy (PANcreatic cancer Dietary Assessment - PanDA): a study protocol

Lindsay Carnie, Angela Lamarca, Katharine Vaughan, Zainul Abedin Kapacee, Lynne McCallum, Alison Backen, Jorge Barriuso, Mairead Mcnamara, Richard Hubner, Marc Abraham, Juan Valle

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction
Pancreatic exocrine insufficiency (PEI) in patients with pancreatic malignancy is well documented in the literature and is known to negatively impact on overall survival and quality of life. A lack of consensus opinion remains on the optimal diagnostic test that can be adapted for use in a clinical setting for this cohort of patients. This study aims to better understand the prevalence of PEI and the most suitable diagnostic techniques in patients with advanced pancreatic malignancy.
Methods and analysis
This prospective observational study, will be carried out in patients with pancreatic malignancy (including adenocarcinoma and neuroendocrine neoplasms). Consecutive patients with inoperable pancreatic malignancy referred for consideration of first-line chemotherapy will be considered for eligibility. The study comprises of three cohorts: demographic cohort (primary objective to prospectively investigate the prevalence of PEI in patients with inoperable pancreatic malignancy) ; sample size 50, diagnostic cohort (primary objective to design and evaluate an optimal diagnostic panel to detect PEI in patients with inoperable pancreatic malignancy); sample size 25 and follow-up cohort (primary objective to prospectively evaluate the proposed PEI diagnostic panel in a cohort of patients with inoperable pancreatic malignancy); sample size 50. The following is a summary of the protocol and methodology.
Ethics and dissemination
Full ethical approval has been granted by the North West Greater Manchester East Research and Ethics Committee, reference: 17/NW/0597. This manuscript reflects the latest protocol v.8 approved 21st April, 2020. Findings will be disseminated by presentation in national/international conferences, publication in peer review journals and distribution via patient advocate groups.
Original languageEnglish
JournalBMJ Open
Publication statusAccepted/In press - 12 Mar 2021

Fingerprint

Dive into the research topics of 'Prospective observational study of prevalence, assessment and treatment of pancreatic exocrine insufficiency in patients with inoperable pancreatic malignancy (PANcreatic cancer Dietary Assessment - PanDA): a study protocol'. Together they form a unique fingerprint.

Cite this