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

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. 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. 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. 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.