A prospective single-center protocol for using near-infrared fluorescence imaging with indocyanine green during staging laparoscopy to detect small metastasis from pancreatic cancer

BACKGROUND: Pancreatic resection and radiotherapy are powerful tools in the multidisciplinary local treatment of pancreatic ductal adenocarcinoma (PDAC). However, 10–20% of patients with preoperatively resectable PDAC have radiographically occult metastases, which results in laparotomy without resection. This study aims to explore the utility of intraoperative near-infrared (NIR) imaging with indocyanine green (ICG) during staging laparoscopy to detect PDAC metastasis. METHODS: This prospective study will evaluate patients with radiographically non-metastatic PDAC before they undergo planned pancreatic resection or chemoradiotherapy. Enrolled patients will receive ICG intravenously (0.5 mg/kg) before the staging laparoscopy. During the staging laparoscopy, the abdominal cavity will be observed using standard white-light laparoscopic imaging and then using NIR-ICG imaging. Suspicious lesions that are detected using standard imaging and/or NIR-ICG imaging will be examined intraoperatively using frozen sections and permanent specimens. We will evaluate the benefit of NIR-ICG imaging based on its ability to identify additional liver or peritoneal lesions that were not detected during standard white-light imaging. DISCUSSION: This study will help establish the clinical utility of NIR-ICG imaging to more precisely identify metastases from radiographically non-metastatic PDAC. This approach may help avoid needless major surgery or radiotherapy. TRIAL REGISTRATION: This protocol was registered on April 1, 2017 on the UMIN Clinical Trials Registry: UMIN000025900 and February 26, 2019 on the Japan Registry of Clinical Trials: jRCT1051180076.