Diagnostic accuracy of contrast-enhanced diffusion-weighted MRI for liver metastases of pancreatic cancer: towards adequate staging and follow-up of pancreatic cancer \u2013 DIA-PANC study: study protocol for an international, multicenter, diagnostic trial

G Litjens,C J H M Van Laarhoven,S A Radema,E J M Van Geenen,D M Rivière,L A A Brosens,J J Hermans,M Prokop

doi:10.1186/s12885-020-07226-0

G Litjens, C J H M Van Laarhoven + Show 6 more

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https://doi.org/10.1186/s12885-020-07226-0

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Abstract

BackgroundAt the time of surgery, approximately 10–20% of the patients with pancreatic cancer are considered unresectable because of unexpected liver metastasis, peritoneal carcinomatosis or locally advanced disease. This leads to futile surgical treatment with all the associated morbidity, mortality and costs. More than 50% of all liver metastases develop in the first six months postoperatively. These (subcentimeter) liver metastases are most likely already present at the time of diagnosis and have not been identified pre-operatively, due to the poor sensitivity of routine preoperative contrast-enhanced CT (CECT).MethodsThe DIA-PANC study is a prospective, international, multicenter, diagnostic cohort study investigating diffusion-weighted, contrast-enhanced MRI for the detection of liver metastases in patients with all stages of pancreatic cancer. Indeterminate or malignant liver lesions on MRI will be further investigated histopathologically. For patients with suspected liver lesions without histopathological proof, follow up imaging with paired CT and MRI at 3-, 6- and 12-months will serve as an alternative reference standard.DiscussionThe DIA-PANC trial is expected to report high-level evidence of the diagnostic accuracy of MRI for the detection of liver metastases, resulting in significant value for clinical decision making, guideline development and improved stratification for treatment strategies and future trials. Furthermore, DIA-PANC will contribute to our knowledge of liver metastases regarding incidence, imaging characteristics, their number and extent, and their change in time with or without treatment. It will enhance the worldwide implementation of MRI and consequently improve personalized treatment of patients with suspected pancreatic ductal adenocarcinoma.Trial registrationClinicalTrials.gov Identifier: NCT03469726. Registered on March 19th 2018 - Retrospectively registered.

Highlights

At the time of surgery, approximately 10–20% of the patients with pancreatic cancer are considered unresectable because of unexpected liver metastasis, peritoneal carcinomatosis or locally advanced disease
The purpose of the DIA-PANC trial is to investigate the diagnostic accuracy of contrast-enhanced diffusionweighted Magnetic Resonance Imaging (MRI) in patients with suspected Pancreatic ductal adenocarcinoma (PDAC) for the detection of liver metastases
We will evaluate whether performing contrast-enhanced diffusion-weighted MRI will improve the detection of liver metastases compared to contrast-enhanced CT (CECT) by determining the sensitivity and specificity of CECT for the detection of liver metastases

Summary

Introduction

At the time of surgery, approximately 10–20% of the patients with pancreatic cancer are considered unresectable because of unexpected liver metastasis, peritoneal carcinomatosis or locally advanced disease. This leads to futile surgical treatment with all the associated morbidity, mortality and costs. Developments in pancreatic cancer diagnostics, surgical techniques and treatment have hardly improved the survival rate in the past 40 years. At the time of surgery, approximately 10–20% of the patients are considered unresectable because of unexpected liver metastasis, peritoneal carcinomatosis or locally advanced disease [4,5,6]

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