utility and usability of activsight™ laser speckle imaging in visualization of tissue perfusion and blood flow during esophageal surgery in humans

Conditions: Esophagus Cancer; Esophageal Cancer; Esophageal Neoplasms; Esophageal Diseases; Esophageal Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Esophagus SCC; Esophagus Tumor; Esophagus Adenocarcinoma; Esophagus Neoplasm

Summary: activsight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. a small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. primary objective: to determine the feasibility of activsight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut anastomoses in esophageal resection/reconstructive surgery. the investigators will compare the precision and accuracy among the naked eye inspection, icg and lsci in assessing the vascularity of the conduit.

design: * this is a prospective interventional cross-over study where activsight™ will be used in sequence to the standard practice of visualizing perfusion status of the conduit using the naked eye visual inspection and icg during esophageal resection. * feasibility will be determined by technically successful completion of intended visualization. * safety will be determined through clinical assessments and evaluation of any adverse event. * assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to icg-based visualization and usability. * patient outcome and follow up to postoperative day 28 will be monitored for clinical outcome. * target enrollment for the assessment of esophageal anastomoses is a total of seventy patients powered to detect \~ 2-3 cm discordance between icg and lsci lines of demarcation between well vascularized and less vascularized sites in the gastric conduit. since activsight™ can detect the difference of \> 2 cm between perfused versus less perfused in comparison to icg with 80 % confidence at p\<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. with potential unforeseen dropout and mortality, the investigators will recruit a total of 70 patients for the proposed study.

Eligibility criteria:
inclusion criteria all patients age \> 18 years old undergoing laparoscopic esophageal resection and reconstruction surgery; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent. diagnosis: * all patients with a clinical suspicion and diagnosis of benign or malignant, small or large bowel lesions requiring surgical resection. * typical imaging as per standard workup findings including us, ct and/or mri. plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis. location of pathology or resected segment: \* target lesions can be located in any fore-, mid- or hindgut segments requiring reconstruction and anastomoses. prior therapy: \* patients with prior surgery are eligible for enrollment. laboratory: * hemoglobin \> 9 g/dl * platelet count ≥75,000/µl (may receive transfusions) * normal pt, ptt and inr \< 1.5 x uln (including patients on prophylactic anticoagulation) * renal function: age-adjusted normal serum creatinine derived from schwartz formula for estimating gfr by the cdc or a creatinine clearance ≥60 ml/min/1.73 m2 for safe * adequate pulmonary function: defined as no dyspnea at rest, and a pulse oximetry \>94% on room air if there is clinical indication for determination. exclusion criteria * there is no exclusion criteria for activsighttm for esophageal surgery. * patients assigned to fda cleared icg-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to icg or anaphylaxis, known allergy to iodides, breast-feeding or being of reproductive age with pregnancy possible and not ruled out, and pregnancy. * patients currently in any investigational agents.

Keywords: laparoscopic robot assisted surgery gastrointestinal anastomoses esophagectomy esophageal surgery thoracic surgery alimentary surgery perfusion indocyanine green (icg) laser speckle contrast imaging (lsci) cancer minimally invasive surgery (mis)