Rare Diseases

All Conditions

Esophageal Cancer

All patients eligible to participate in this study.

Patient will undergo the standard-of-care gastric conduit procedure and in addition, peroperative Laser Speckle Contrast Imaging of the gastric conduit and eosophagus will be performed.

Laser Speckle Contrast Imaging using the PerfusiX-Imaging device

E.C. Boerma, MD/PhD

J.P.E.N. Pierie, MD/PhD

Rationale Globally, esophageal cancer is the seventh most common cancer type, with over half a million cases reported in 2020. The survival of gastroesophageal cancer is poor and the prognosis is primarily determined by the possibilities for curative treatment. After resection of part of the esophagus and cardia, the reconstruction of the esophagus is performed with a gastric conduit where an anastomosis is made with the proximal esophageal stump. Globally, a Minimally invasive Esophagectomy (MIE) has a high morbidity rate and a mortality rate ranging up to 5% as a result of the procedure. One of the most feared complications is an anastomotic leakage (AL) with a rate of around 12.5% and a mortality rate of around 15%. AL is associated with prolonged hospital stay and increased re-operation rates. It is generally accepted that impaired blood flow of the gastric conduit is the most important cause of AL. The surgical procedure of an esophagectomy and reconstruction inherently compromises the blood supply of the gastric conduit. However other than the surgical eye, there is no gold standard in assessing this. Surgeons generally look for traditional indicators of tissue viability such as pulsating vessels, bleeding of the resected edges, tissue color and intestinal motility. However, an objective indication of the tissue perfusion is still lacking, implying the clinical need for one.

Objectives In this trial the investigators will study the utility of PerfusiX-Imaging for perfusion assessment of the gastric conduit in comparison with the standard of care.

Study design The current study is a prospective, observational single-center study in the Medical Center Leeuwarden.

Study population A total of 30 patients undergoing an esophageal resection will be included. Patient related study procedures All patients will undergo the standard-of-care program which includes perfusion assessment by the surgical eye and ICG-fluorescence imaging. In addition to this standard-of-care, 2D-perfusion maps will be generated from images taken with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands) in combination with a standard surgical laparoscope. Not related to the patient, the PerfusiX-Imaging images will be shown to the surgeon postoperatively and peroperative questionnaires will be filled regarding the standard-of-care perfusion assessment.

Study parameters/endpoints Due to the explorative character of this study, there is no formal hierarchy in the respective endpoints of this study. In this, all endpoints will add to the overall assessment of the feasibility of the PerfusiX-imaging derived visual feedback. The investigators will look at the percentage of operating surgeons that indicated no change in location of the anastomosis or operating plan based on the additional PerfusiX-Imaging. The percentage of the non-involved surgeons that indicated no change in location of the anastomosis or operating plan based on the additional PerfusiX-Imaging. And the homogeneity of the change in location between non-involved surgeons for individual patients will be analyzed in order to get a sense for the subjectivity of the interpretation of the images.

The investigators will also compare the additional PerfusiX-Imaging derived visual feedback to the standard of care by looking at the homogeneity in location of the watershed area between PerfusiX-Imaging, ICG-fluorescence and based on visual assessment by the surgical eye. The difference in the location of watershed area between PerfusiX-Imaging and ICG-fluorescence or based on visual assessment.

In order to get a sense of the scale of the indicated change in location of the anastomosis the investigators will look at the estimated change in location of the anastomosis of the gastric conduit/ the esophageal stump in centimeters by the operating surgeon. The estimated change in location of the anastomosis of the gastric conduit/ the esophageal stump in centimeters by non-involved surgeons. Lastly, the investigators will compare the change in the location of the anastomosis by non-involved surgeons in comparison to the operating surgeon; Burden, risk and benefit to participation Burden Not applicable. Risks Not applicable. Benefit Not applicable.

Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit

Laser Speckle Contrast Imaging, Surgical Eye and Indocyanine Green Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit

- Number of operating surgeons to indicate a change in location of anastomosis (Yes/no, %, with 95% confidence interval)

- Number of non-involved surgeons to indicate a change in location of anastomosis (Yes/no, %, with 95% confidence interval)

- Difference in location of watershed area in centimeters between PerfusiX, ICG-fluorescence and surgical eye (Means with standard deviation, median with range)

- Proximal or medial direction of change (Yes/no, %, with 95% confidence interval)

- Change in location of anastomosis in centimeters (Means with standard deviation, median with range)

- Proximal or medial direction of change (Yes/no, %)

- Number of patients developing AL (Percentage, %, with 95% confidence interval)

- AL characteristics (localization, tumor type, type of hemicolectomy, diagnosed with, treatment)

- Extra time taken for imaging protocol in seconds (Means with standard deviation, median with range)

University of Groningen

LIMIS Development

Medical Centre Leeuwarden

Neoplasms

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Imaging camera scan that uses reflected red light to take pictures of the amount of blood flowing in brain and the amount of oxygen in blood.

Speckle-Contrast Imaging

Jeffrey Weinberg, MD

The goal of this proposal is to test the performance of a novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery.

This pilot study encompasses two sub-aims:

* Evaluate the ability of laser speckle contrast imaging to image cerebral blood flow (CBF) intraoperatively. We will image the changes in CBF in response to somatosensory stimulation. (5 patients).
* Simultaneously image hemoglobin oxygenation, blood volume, blood flow, and cerebral metabolic rate of oxygen (CMRO2) changes during somatosensory stimulation using a combined laser speckle and multi-wavelength reflectance imaging system. (5 patients).

A speckle-contrast imaging camera uses a low-power laser to check brain activity. The imaging camera uses reflected red light to take a special kind of picture of the amount of blood flowing in your brain, and the amount of oxygen in your blood. This is the first time this device has been used in brain surgery.

While "asleep" under anesthesia during an already scheduled surgery, the neurosurgeon will position the microscope to take pictures of the surgery area. The pictures will be taken after the brain is exposed, but before the rest of the surgery takes place. Researchers will shine the red light onto the brain during your surgery. The light will then be seen by the camera.

"Cortical mapping" will done, which is an established procedure used to detect important areas of the brain. Usually, a nerve in the wrist is stimulated with a very small shock of electricity and a response is detected in the brain by an electrode placed on the surface. The electrical shock administered is not dangerous or painful. It will be given while "asleep." For the experimental procedure used in this study, the same stimulation will be used, but the impulse detection will be performed using the speckle-contrast imaging camera. Researchers hope to see if the change in blood flow gives the same information as if the electrode was placed on the brain and used to detect the electricity. Doing both procedures is expected to take no more than 20 minutes. During this time, continual monitoring done by the surgeon and operating room staff.

Your participation in this study will end when the surgery is finished.

The results of this study will not be used by the surgeon during your surgery or any future treatments. These measurements are being done for research only and will not be used by the surgeon to make any decisions about your surgery.

This is an investigational study. This device is investigational and has not been approved by the Food and Drug Administration (FDA), but it has been declared safe by the National Institutes of Health. Up to 10 patients will take part in the study. All will be enrolled at M. D. Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit	NCT05685862	Oesophageal Can...	Laser Speckle C...	18 Years -	Medical Centre Leeuwarden
Intraoperative Optical Imaging of Brain Function	NCT00632437	Brain Tumor	Speckle-Contras...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for laser speckle contrast imaging