Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN.
Thomas M Pausch, Magdalena Holze, Josefin El-Mahdy, Bodil Gesslein, Helena Ossmer Thedius, Anja Sander, Solveig Tenckhoff, Tom Sundermann, Jan Larmann, Pascal Probst, Frank Pianka, Rosa Klotz, Thilo Hackert
Author Information
Thomas M Pausch: From the Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Magdalena Holze: From the Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Josefin El-Mahdy: From the Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Background: The invisible fluid leaking from a partially resected pancreas is associated with complications including postoperative pancreatic fistula (POPF), calling for strategies to visualize intraoperative leakage. This single-arm, monocentric trial aims to evaluate the usefulness and safety of SmartPAN, a hydrogel that reacts to alkali pancreatic fluids by changing color and thus enables the surgeon to take immediate action to close leakage. Methods: patients awaiting partial pancreatic resection for any indication were recruited to receive intraoperative SmartPAN application. Trial endpoints covered SmartPAN usability and safety according to reports completed by surgeons after each operation, laboratory measurements of nonbiodegradable compounds in body fluids, and clinical evaluations over 30 days of follow-up. Results: In total 42 patients were recruited to the trial and 29 received partial pancreatic resection with SmartPAN application according to protocol. All 16 attending surgeons rated SmartPAN as easy to learn and use, mostly agreeing that it was useful and that they intended to use it frequently. No adverse effects or complications were associated with SmartPAN, nor were its compounds detected in blood or abdominal fluids. Positive leakage response was detected in 10/29 surgeries. POPF developed in 7 patients, including 2 intraoperatively detected leakages, thereof 1 with targeted closure as well as 5 with no leakage detected. Conclusion: This study represents the first-in-human clinical trial of SmartPAN and the precursor to randomized controlled trials. The outcomes support SmartPAN's clinical usability and safety and showcase the device's potential to intraoperatively visualize precursors of POPF.
