Peroral Pancreatoscopy (PP) for Pancreatic Stone Therapy and Investigation of Susptected Pancreatic Lesions - First Human Experience Using the Spyglass Direct Visualization System (SDVS)

Abstract

Introduction: PP offers direct access and visualization of the pancreatic ducts with the potential to enhance visual diagnosis, direct tissue sampling, and guide therapy. Recently, a single operator modular system consisting of a 10Fr disposable catheter with 4-way tip deflection, reusable optical probe, 1.2 mm working channel and dedicated irrigation channels was released for clinical use in the biliary system (Spyglass Direct Visualization System, Boston Scientific Corporation, Marlboro, MA). Methods: The goal of this study is to document the performance, safety, and utility of the SDVS in patients requiring PP for stone therapy or investigation of suspicious lesions with or without biopsy. Procedural success was defined as ability to access and visualize the target lesion, obtain biopsies, or achieve stone clearance as needed. Results: 48 consecutive pts (median age 67 yo, IQR 17-88; 26M/22F) underwent PP using the SDVS. Indications for PP were: pancreatic stones (17), indeterminate strictures (11), dilated ducts (5), indeterminated filling defects (11), mass (4). 31 pts had sphincterotomy: 14 had prior sphincterotomy, 14 required pancreatic sphincterotomy during the procedure, 2 required extension. The mean pancreatic duct diameter was 7.6 mm. Stones were located in the head (16) and tail (1); mean diameter of largest stone in each case was 9.4 mm (SD 5.7). EHL was attempted in 10 pts and stone clearance was achieved in 8 pts (80%) after a mean of 1.2 SDVS-guided EHL sessions (SD 0.44). EHL was planned but not performed in 2 other pts because of technical difficulties (unable to visually target stones for EHL (1); unable to pass the EHL probe through Spyscope (1). PP-guided biopsies were attempted in 10 pts using a disposable Spybite forceps. A mean of 4.4 (SD 1.7) biopsy specimens per case provided adequate samples for histologic evaluation in all patients. No serious adverse events, and only one mild adverse event, related to PP or SDVS devices were reported. Conclusions: PP using the Spyglass DVS System is technically feasible, allowing access to target sites in the main pancreatic duct for visual inspection, stone therapy and tissue sampling in most patients. Based on this preliminary experience, PP can be safely performed in patients with pancreatic stones, IPMN and indeterminate strictures, however, its safety and clinical utility in patients with small ducts and/or non-obstructed ducts remains to be proven. A smaller catheter diameter is preferred for pancreatic application.