Can we predict necrosis intra-operatively? Real-time optical quantitative perfusion imaging in surgery: study protocol for a prospective, observational, in vivo pilot study
Autor: | Simon D. Strackee, Suzanne S. Gisbertz, Mark I. van Berge Henegouwen, Ton G. van Leeuwen, Daniel M. de Bruin, Denise P. Veelo, Sanne M. Jansen |
---|---|
Přispěvatelé: | APH - Personalized Medicine, APH - Quality of Care, Biomedical Engineering and Physics, Graduate School, Urology, Surgery, Plastic, Reconstructive and Hand Surgery, Anesthesiology, Amsterdam Cardiovascular Sciences, Amsterdam Gastroenterology Endocrinology Metabolism, APH - Digital Health, ACS - Diabetes & metabolism, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias |
Rok vydání: | 2016 |
Předmět: |
Reconstructive surgery
medicine.medical_specialty Fluorescence-lifetime imaging microscopy Monitoring medicine.medical_treatment Medicine (miscellaneous) Perfusion scanning Free flap 01 natural sciences Optical technologies Fluorescence imaging 010309 optics 03 medical and health sciences Study Protocol Necrosis 0302 clinical medicine Optical coherence tomography 0103 physical sciences medicine Anastomotic leakage Laser speckle contrast imaging Accuracy lcsh:R5-920 medicine.diagnostic_test Sidestream darkfield microscopy business.industry Feasibility Risk prediction Surgery Transplantation Perfusion Esophagectomy 030220 oncology & carcinogenesis lcsh:Medicine (General) business |
Zdroj: | Pilot and Feasibility Studies Pilot and feasibility studies, 3:65. BioMed Central Ltd. Pilot and Feasibility Studies, Vol 3, Iss 1, Pp 1-8 (2017) |
ISSN: | 2055-5784 |
Popis: | Compromised perfusion as a result of surgical intervention causes a reduction of oxygen and nutrients in tissue and therefore decreased tissue vitality. Quantitative imaging of tissue perfusion during reconstructive surgery, therefore, may reduce the incidence of complications. Non-invasive optical techniques allow real-time tissue imaging, with high resolution and high contrast. The objectives of this study are, first, to assess the feasibility and accuracy of optical coherence tomography (OCT), sidestream darkfield microscopy (SDF), laser speckle contrast imaging (LSCI), and fluorescence imaging (FI) for quantitative perfusion imaging and, second, to identify/search for criteria that enable risk prediction of necrosis during gastric tube and free flap reconstruction. This prospective, multicenter, observational in vivo pilot study will assess tissue perfusion using four optical technologies: OCT, SDF, LSCI, and FI in 40 patients: 20 patients who will undergo gastric tube reconstruction after esophagectomy and 20 patients who will undergo free flap surgery. Intra-operative images of gastric perfusion will be obtained directly after reconstruction at four perfusion areas. Feasibility of perfusion imaging will be analyzed per technique. Quantitative parameters directly related to perfusion will be scored per perfusion area, and differences between biologically good versus reduced perfusion will be tested statistically. Patient outcome will be correlated to images and perfusion parameters. Differences in perfusion parameters before and after a bolus of ephedrine will be tested for significance. This study will identify quantitative perfusion-related parameters for an objective assessment of tissue perfusion during surgery. This will likely allow early risk stratification of necrosis development, which will aid in achieving a reduction of complications in gastric tube reconstruction and free flap transplantation. Clinicaltrials.gov registration number NCT02902549 . Dutch Central Committee on Research Involving Human Subjects registration number NL52377.018.15. |
Databáze: | OpenAIRE |
Externí odkaz: |