In: Journal of Biomaterials Applications, 35 (2020), Nr. 1. pp. 123-134. ISSN 0885-3282 (Druck-Ausg.), 1530-8022 (Online-Ausg.)
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Abstract
Postoperative pancreatic fistula is a major surgical complication that can follow pancreatic resection. Postoperative pancreatic fistula can develop as a consequence of leaking pancreatic fluid, which calls for an intraoperative indicator of leakage. But suitable indicators of pancreatic leakage have yet to be found. This study details the evidence-based development and early efficacy assessments of a novel pancreatic leakage indicator (SmartPAN), following the IDEAL framework of product development.We developed 41 SmartPAN prototypes by combining indicators of pancreatic fluid with a polysaccharide-microsphere matrix. The prototypes were assessed in vitro using porcine (Sus scrofa domesticus) pancreatic tissue and ex vivo with human pancreatic fluid. From these initial tests, we chose a hydrogel-based compound that uses the pH indicator bromothymol blue to detect alkali pancreatic fluid. This prototype was then assessed in vivo for usability, effectiveness and reliability using a porcine model. Treatment groups were defined by SmartPAN-reaction at initial pancreatic resection: indicator-positive or negative. Indicator-positive individuals randomly received either targeted closure of leakage sites or no further closure. We assessed SmartPAN’s reliability and effectiveness by monitoring abdominal drainage for amylase and with relaparotomy after 48 h. SmartPAN responses were consistent between both surgical procedures and conformed to amylase measurements. In conclusion, we have developed the first surgery-ready indicator for predicting the occurrence of pancreatic leakage during pancreatic resection. SmartPAN can enable targeted prophylactic closure in a simple and reliable way, and thus may reduce the impact of postoperative pancreatic fistula by guiding peri- and post-operative management.
Document type: | Article |
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Journal or Publication Title: | Journal of Biomaterials Applications |
Volume: | 35 |
Number: | 1 |
Publisher: | Sage |
Place of Publication: | London ; Thousand Oaks, Calif. |
Date Deposited: | 28 Jul 2020 16:27 |
Date: | 2020 |
ISSN: | 0885-3282 (Druck-Ausg.), 1530-8022 (Online-Ausg.) |
Page Range: | pp. 123-134 |
Faculties / Institutes: | Medizinische Fakultät Heidelberg > Chirurgische Universitätsklinik |
DDC-classification: | 610 Medical sciences Medicine |
Uncontrolled Keywords: | Pancreas, fistula, indicator, surgery, resection, IDEAL |
Additional Information: | Dieser Beitrag ist aufgrund einer (DFG-geförderten) Allianz bzw. Nationallizenz frei zugänglich. This publication is freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively. |