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

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 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 21 April 2020. Findings will be disseminated by presentation at national/international conferences, publication in peer-review journals and distribution via patient advocate groups.

Trial registration number: 194255, NCT0361643.

Keywords: gastrointestinal tumours; nutrition & dietetics; nutritional support; pancreatic disease.

Conflict of interest statement

Competing interests: LC reports grants from Pancreatic Cancer UK andNeuroendocrine Cancer UK (formerly known as the NET Patient Foundation), during the conduct of the study; travel and educational support from Mylan and Ipsen, outside the submitted work; AL reports grants and personal fees: travel and educational support from Ipsen, Pfizer, Bayer, AAA, SirtEx, Novartis, Mylan and Delcath. Speaker honoraria from Merck, Pfizer, Ipsen, Incyte and AAA. Advisory honoraria from EISAI, Nutricia Ipsen, QED and Roche. Member of the Knowledge Network and NETConnect Initiatives funded by Ipsen. All outside the submitted work; ZAK reports educational and travel support from EISAI, outside the submitted work; MGM reports grants from NuCana, grants from Servier, grants from Ipsen, other from Novartis, outside the submitted work; RH reports personal fees from Ipsen, Mylan, Celgene and PrimeOncology, outside the submitted work; MA reports travel and educational support from Mylan, outside the submitted work; JWV reports personal fees from AstraZeneca, Debiopharm, Delcath Systems, Genoscience Pharma, Imaging Equipment Limited, Incyte, Ipsen, Keocyt, Merck, Mundipharma EDO, Novartis, PCI Biotech, Pieris Pharmaceuticals, QED, Wren Laboratories and Agios; grants, personal fees and non-financial support from NuCana, personal fees and non-financial support from Pfizer, grants and personal fees from Servier, outside the submitted work; KV, LM, AB and JB have nothing to declare.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Study design overview.

Figure 2

Study objective. PEI, pancreatic exocrine insufficiency; PERT, pancreatic enzyme replacement therapy.

Figure 3

Clinical assessment by cohort. Patients in the follow-up cohort will be reviewed (at week 6, month 3 and month 6 from study entry) by the study dietitian for further intervention and assessment. BMI, body mass index; HbA1C, haemoglobin A1C; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MUAC, mid-upper arm circumference; PEI, pancreatic exocrine insufficiency; PERT, pancreatic enzyme replacement therapy; PS, performance status; QoL, quality of life.