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DEPEND study protocol: early detection of patients with pancreatic cancer - a pilot study to evaluate the utility of faecal elastase-1 and 13C-mixed triglyceride breath test as screening tools in high-risk individuals

DEPEND study protocol: early detection of patients with pancreatic cancer - a pilot study to evaluate the utility of faecal elastase-1 and 13C-mixed triglyceride breath test as screening tools in high-risk individuals
DEPEND study protocol: early detection of patients with pancreatic cancer - a pilot study to evaluate the utility of faecal elastase-1 and 13C-mixed triglyceride breath test as screening tools in high-risk individuals

INTRODUCTION: Pancreatic cancer (PC) is the fifth leading cause of cancer-related death in the UK. The incidence of PC is increasing, with little or no improvement in overall survival and the best chance for long-term survival in patients with PC relies on early detection and surgical resection. In this study, we propose the use of a diagnostic algorithm that combines tests of pancreatic exocrine function (faecal elastase-1 (FE-1) test and the 13C-mixed triglyceride (13C-MTG) breath test) to identify patients with PC that urgently needs imaging studies.

METHODS AND ANALYSIS: This prospective pilot (proof of concept) study will be carried out on 25 patients with resectable PC, 10 patients with chronic pancreatitis and 25 healthy volunteers. This study will construct a predictive algorithm for PC, using two tests of pancreatic exocrine function, FE-1 test and the 13C-MTG breath test. Continuous flow isotope ratio mass spectrometry in the 13C-MTG breath test will be used to analyse enriched 13CO2 in exhaled breath samples. The additional predictive benefit of other potential biomarkers of PC will also be considered. Potential biomarkers of PC showing abilities to discriminate between patients with PC from healthy subjects or patients with chronic pancreatitis will be selected by metabolomic analysis.

ETHICS AND DISSEMINATION: The study was approved by the North of Scotland Research and Ethics Committee on 1 October 2020 (reference: 20/NS/0105, favourable opinion granted). The results will be disseminated in presentations at academic national/international conferences and publication in peer-review journals.

biochemistry, endocrine tumours, gastrointestinal tumours, pancreatic disease, pancreatic surgery
2044-6055
Afolabi, Paul Remi
757e7f01-664c-493e-bc51-c6a2c933dc22
McDonnell, Declan
b7499481-73e7-4130-897e-cd4200c8a43b
Byrne, Christopher D
1370b997-cead-4229-83a7-53301ed2a43c
Wilding, Sam
1f316b8b-db59-4289-b6aa-183f957f3470
Goss, Victoria
ef02be5d-9318-4f7d-b076-3153555980d0
Walters, Jocelyn
a9041dd0-b700-4182-98ce-f02b73f15d5a
Hamady, Zaed Z
25ba9e1a-394c-444c-a407-ac0160231af0
Afolabi, Paul Remi
757e7f01-664c-493e-bc51-c6a2c933dc22
McDonnell, Declan
b7499481-73e7-4130-897e-cd4200c8a43b
Byrne, Christopher D
1370b997-cead-4229-83a7-53301ed2a43c
Wilding, Sam
1f316b8b-db59-4289-b6aa-183f957f3470
Goss, Victoria
ef02be5d-9318-4f7d-b076-3153555980d0
Walters, Jocelyn
a9041dd0-b700-4182-98ce-f02b73f15d5a
Hamady, Zaed Z
25ba9e1a-394c-444c-a407-ac0160231af0

Afolabi, Paul Remi, McDonnell, Declan, Byrne, Christopher D, Wilding, Sam, Goss, Victoria, Walters, Jocelyn and Hamady, Zaed Z (2022) DEPEND study protocol: early detection of patients with pancreatic cancer - a pilot study to evaluate the utility of faecal elastase-1 and 13C-mixed triglyceride breath test as screening tools in high-risk individuals. BMJ Open, 12 (2), [e057271]. (doi:10.1136/bmjopen-2021-057271).

Record type: Article

Abstract

INTRODUCTION: Pancreatic cancer (PC) is the fifth leading cause of cancer-related death in the UK. The incidence of PC is increasing, with little or no improvement in overall survival and the best chance for long-term survival in patients with PC relies on early detection and surgical resection. In this study, we propose the use of a diagnostic algorithm that combines tests of pancreatic exocrine function (faecal elastase-1 (FE-1) test and the 13C-mixed triglyceride (13C-MTG) breath test) to identify patients with PC that urgently needs imaging studies.

METHODS AND ANALYSIS: This prospective pilot (proof of concept) study will be carried out on 25 patients with resectable PC, 10 patients with chronic pancreatitis and 25 healthy volunteers. This study will construct a predictive algorithm for PC, using two tests of pancreatic exocrine function, FE-1 test and the 13C-MTG breath test. Continuous flow isotope ratio mass spectrometry in the 13C-MTG breath test will be used to analyse enriched 13CO2 in exhaled breath samples. The additional predictive benefit of other potential biomarkers of PC will also be considered. Potential biomarkers of PC showing abilities to discriminate between patients with PC from healthy subjects or patients with chronic pancreatitis will be selected by metabolomic analysis.

ETHICS AND DISSEMINATION: The study was approved by the North of Scotland Research and Ethics Committee on 1 October 2020 (reference: 20/NS/0105, favourable opinion granted). The results will be disseminated in presentations at academic national/international conferences and publication in peer-review journals.

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Accepted/In Press date: 7 February 2022
Published date: 25 February 2022
Keywords: biochemistry, endocrine tumours, gastrointestinal tumours, pancreatic disease, pancreatic surgery

Identifiers

Local EPrints ID: 455756
URI: http://eprints.soton.ac.uk/id/eprint/455756
ISSN: 2044-6055
PURE UUID: fcef916f-c630-421c-a108-794c4da584d9
ORCID for Paul Remi Afolabi: ORCID iD orcid.org/0000-0002-0553-1578
ORCID for Christopher D Byrne: ORCID iD orcid.org/0000-0001-6322-7753

Catalogue record

Date deposited: 01 Apr 2022 18:27
Last modified: 19 Oct 2022 01:36

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Contributors

Author: Paul Remi Afolabi ORCID iD
Author: Declan McDonnell
Author: Sam Wilding
Author: Victoria Goss
Author: Jocelyn Walters
Author: Zaed Z Hamady

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