Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN
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...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Health
2025-03-01
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| Series: | Annals of Surgery Open |
| Online Access: | http://journals.lww.com/10.1097/AS9.0000000000000529 |
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| author | Thomas M. Pausch, MD Magdalena Holze, MD Josefin El-Mahdy Bodil Gesslein, PhD Helena Ossmer Thedius Anja Sander, PhD Solveig Tenckhoff, PhD Tom Sundermann, PhD Jan Larmann, MD Pascal Probst, PhD Frank Pianka, MD Rosa Klotz, MD Thilo Hackert, MD |
| author_facet | Thomas M. Pausch, MD Magdalena Holze, MD Josefin El-Mahdy Bodil Gesslein, PhD Helena Ossmer Thedius Anja Sander, PhD Solveig Tenckhoff, PhD Tom Sundermann, PhD Jan Larmann, MD Pascal Probst, PhD Frank Pianka, MD Rosa Klotz, MD Thilo Hackert, MD |
| author_sort | Thomas M. Pausch, MD |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-7b0d2aa279fd40fb8af990f4995a5c6e |
| institution | DOAJ |
| issn | 2691-3593 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Wolters Kluwer Health |
| record_format | Article |
| series | Annals of Surgery Open |
| spelling | doaj-art-7b0d2aa279fd40fb8af990f4995a5c6e2025-08-20T02:42:08ZengWolters Kluwer HealthAnnals of Surgery Open2691-35932025-03-0161e52910.1097/AS9.0000000000000529202503000-00029Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPANThomas M. Pausch, MD0Magdalena Holze, MD1Josefin El-Mahdy2Bodil Gesslein, PhD3Helena Ossmer Thedius4Anja Sander, PhD5Solveig Tenckhoff, PhD6Tom Sundermann, PhD7Jan Larmann, MD8Pascal Probst, PhD9Frank Pianka, MD10Rosa Klotz, MD11Thilo Hackert, MD12From the * Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, GermanyFrom the * Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, GermanyFrom the * Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany‡ Magle Chemoswed AB, Malmö, Sweden‡ Magle Chemoswed AB, Malmö, Sweden§ Institute of Medical Biometry, Heidelberg University Hospital, Heidelberg, Germany† Study Centre of the German Society of Surgery (SDGC), Heidelberg University, Heidelberg, Germany∥ Institute of Forensic and Traffic Medicine, Heidelberg University Hospital, Heidelberg, Germany¶ Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, GermanyFrom the * Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, GermanyFrom the * Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, GermanyFrom the * Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, GermanyFrom the * Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, GermanyBackground:. 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.http://journals.lww.com/10.1097/AS9.0000000000000529 |
| spellingShingle | Thomas M. Pausch, MD Magdalena Holze, MD Josefin El-Mahdy Bodil Gesslein, PhD Helena Ossmer Thedius Anja Sander, PhD Solveig Tenckhoff, PhD Tom Sundermann, PhD Jan Larmann, MD Pascal Probst, PhD Frank Pianka, MD Rosa Klotz, MD Thilo Hackert, MD Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN Annals of Surgery Open |
| title | Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN |
| title_full | Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN |
| title_fullStr | Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN |
| title_full_unstemmed | Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN |
| title_short | Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN |
| title_sort | visualization of intraoperative pancreatic leakage vip the ideal stage i first in human single arm clinical pilot trial of smartpan |
| url | http://journals.lww.com/10.1097/AS9.0000000000000529 |
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