INTRAOPERATIVE PANCREATOSCOPY DURING PANCREATECTOMY IN PATIENTS WITH INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM INVOLVING THE MAIN PANCREATIC DUCT: PROSPECTIVE MULTICENTER STUDY

Background & Aims: Minimal prospective data are available on intraoperative pancreatoscopy (IOP) for the diagnostic work-up of intraductal papillary mucinous neoplasia (IPMN). The aim of the current report is to summarize perioperative impact on patient management from an ongoing 5-year prospective cohort study of IOP in patients with pancreatic surgery for suspected or confirmed IPMN.

Methods: Prospective multicenter study in patients with main pancreatic duct (MPD) diameter >5mm on preoperative imaging and scheduled for surgery for suspected MPD IPMN or mixed-type IPMN in 8 centers from 6 countries. IOP was performed using SpyGlass™ DS Direct Visualization System or SpyGlass™ Discover Digital System (Boston Scientific Corporation, Marlborough, Massachusetts) at the time of the index pancreas resection. This was an observational cohort study in which IOP findings were permitted to be interpreted by and acted upon at the discretion of the local surgical team. Patients had postoperative follow-up before hospital discharge and at 4 weeks. Main endpoint was IOP technical success; secondary endpoints included influence of IOP on the surgical resection plan, and 4-week procedure-related serious adverse events (SAEs).

Results: Overall, 100 patients were included, mean age 68.9±8.8 years and 58% male. On preoperative imaging, 94 (94%) patients had IPMN involving the main duct. MPD dilation was >10 mm in 58%, and 5-9 mm in 42% of patients. The operative approach included 45 pancreaticoduodenectomies, 19 PPPD, 14 distal and 11 total pancreatectomies, and 11 other surgeries. Both open and minimally invasive approaches were utilized: 71 (71%) open, 23 (23%) robotic, and 6 (6%) laparoscopic. IOP was technically successful in 91 (91%) patients. In 25 patients (25%), the initial surgical plan was modified based on IOP findings. Their procedural modifications included one or more of the following: extension (8) or sparing (5) of additional parenchymal resection, avoidance of total pancreatectomy (6), removal of cast, stone, or sludge from the remnant duct (2), conversion to total pancreatectomy (3), or conversion from distal pancreatectomy to a pancreatoduodenectomy. (1). Ninety-eight (98.0%) of patients completed a 4-week follow-up visit, one missed the 4-week visit, and one died. There were 25 reported SAEs related to surgery with Clavien-Dindo classification ≥ III in 15 patients, including one Clavien-Dindo V. None were reported as related to IOP.

Conclusion: In this prospective multicenter study, IOP was technically highly feasible and led to changes in intraoperative decision-making in 25% of surgical patients with IPMN and main duct involvement, especially regarding extension or sparing of pancreatic parenchymal resection. No IOP-related SAEs occurred. (ClinicalTrials.gov number NCT03729453)