Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Fluorophosphate

Patients within this arm will undergo a high-resolution CT scan of the chest, which is required by Synapse 3D to create accurate 3D virtual model reconstructions. At the start of the operation, the 3D virtual model of the segmental pulmonary anatomy will be displayed on the da Vinci Robotic platform for operative planning. The model will be used as a guide to determine which vessels are involved in the segment and need to be removed. The surgeon will ligate the pulmonary vein and pulmonary artery of the broncho-pulmonary segment with the lung cancer nodule, isolating it from any blood supply, and mark the proposed segmental planes based on the 3D model. ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, an 8 mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10 mL saline solution bolus

The 3D virtual models provided by Synapse 3D will be made by experts in medical image analysis using the high-resolution CT scans. Patients will have 3D virtual reconstructions of their pulmonary anatomy with the target lesion created pre-operatively.

Synapse 3D Lung Modelling

ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.

IC-Green (ICG)

Peter R. A. Malik, BHSc (Honours)

Yogita S Patel, BSc

Wael C. Hanna, MDCM, MBA, FRCSC

Waël C Hanna, MDCM, MBA, FRCSC

With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.

Lungs are made up of individual lobes. When a lung cancer tumour is found in one of these lobes, the surgeon often performs a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue

For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a Segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue. Research shows that a segmentectomy can result in less blood loss, shorter operation time, less days of having a chest tube, and a shorter hospital stay, compared to a lobectomy.

With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed in order to safely complete the segmentectomy. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed.

In response to these challenges, our surgical group has developed the technique of using Near-Infrared Fluorescence (NIF) mapping with intravascular indocyanine green (ICG) dye injection. With the aid of an infrared camera the surgeon is able to see the segment within a lobe of lung after injection of the ICG dye, allowing for a more accurate segmentectomy. We recently reported a 60% success rate of segmental resections with the use of ICG and NIF-guided surgical resection. However, a limitation to this technique is that the segmental anatomy can only be seen during the operation and only after cutting the blood vessels.

The introduction of 3D reconstruction and virtual modeling provides a new way to locate lesions accurately within a segment and plan the appropriate operation before the actual surgery occurs. Synapse 3D (Mississauga, Canada) is a 3D modelling technology that is capable of producing a detailed 3D virtual model of a patient's lung based on Computed Tomography (CT) scans. It has been shown to be safe and feasible in performing segmental pulmonary resections on a robotic platform. In this study, we propose a new operation that uses 3D anatomical planning before the surgery (Synapse 3D) and real-time NIF-mapping at the time of surgery using ICG dye, which we believe will greatly increase the likelihood of a successful segmentectomy. If this new operation is successful, it will help patients save more of their healthy lung tissue when they are undergoing surgery for lung cancer.

This study is a single centre, prospective clinical trial evaluating the safety and feasibility of adding 3D anatomical reconstructions and real-time intraoperative planning using Synapse 3D software added to NIF-guided targeted segmental resection. It is anticipated that 32 participants will be enrolled within a 1-year period. Enrollment will take place at St. Joseph's Healthcare Hamilton. All patients enrolled will be evaluated until their first scheduled follow-up appointment (within 30 days post-surgery).

Open Label, single-arm feasibility trial.

Synapse 3D With Intravascular Indocyanine Green

Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial

Rate of conversions to lobectomy will be measured by collecting the proportion of conversions to lobectomy.

Post operative complications will be reported and measured using the Ottawa Thoracic Morbidity and Mortality Classification of (a) Adverse reactions to ICG dye at the time of surgery and (b) Perioperative complications through study completion.

Anatomical accuracy will be evaluated using the criteria listed in points a-c. A score of 3/3 on these items will indicate success of anatomical accuracy

1. Ex-vivo localization of lesions;
2. Ex-vivo confirmation of tumor-free margins around lesion;
3. Ex-vivo confirmation of adequate anatomical inter-segmental.

A pre-operative CT scan based, a pre-operative 3D reconstruction based and post segmental resection surgeon confidence score will be obtained on a scale of 1-5:

1 - not at all confident, 2 - somewhat confident, 3 - confident, 4 - very confident, 5 - extremely confident.

Length of time of the operation will be measured by collecting the time the patient entered the operating room until the time the patient left the operating room.

Rate of conversion to thoracotomy will be measured by collecting the proportion of conversions to thoracotomy. Descriptive analysis of reasons for conversion will also be collected.

Duration the patient had chest tubes in situ will be measured by collecting the date of surgery and the date the chest tube was removed.

Duration of hospital length of stay will be measured by collecting the data of admission and the date of discharge.

Estimated blood loss will be measured at the time of operation by OR staff.

St. Joseph's Healthcare Hamilton

Director, Research Program, Boris Family Centre for Robotic Surgery

Symptoms and General Pathology

Behaviors and Mental Disorders

Neoplasm Metastasis

Postoperative Complications

Death

Quality of Life

Preoperative risk stratification Postoperative risk stratification Risk-based, escalating levels of care Risk-based, escalating levels of monitoring Risk-based, escalating levels of co-management

Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure

Preoperative risk stratification

Postoperative risk-prediction tool based on intraoperative variables

Postoperative risk stratification

Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU

Risk-based, escalating levels of care

Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system

Risk-based, escalating levels of monitoring

Risk-based, escalating levels of co-management

Routine postoperative care, as medically indicated

Standard postoperative care

Nestor F Esnaola, MD, MPH, MBA

The primary objective of this trial is to determine if perioperative risk stratification and risk-based, protocol-driven management leads to a reduction in the rate of death or serious complications compared to standard perioperative management in patients undergoing elective major cancer surgery.

Major cancer surgery is associated with significant rates of postoperative mortality and major morbidity. Postoperative morbidity adversely impacts healthcare utilization, healthcare costs, rates of discharge to home, quality of life, rates of receipt of postoperative anti-neoplastic therapy, disease-free survival, and overall survival. The investigators hypothesize that perioperative risk stratification and risk-based, protocol-driven management (compared to standard perioperative management) will lead to a reduction in 30-day post-operative mortality or major morbidity in patients undergoing major cancer surgery. This is based on our theory that preoperative/postoperative use of newly developed, perioperative risk-prediction tools will help identify patients at increased risk of postoperative death or serious complications that might benefit from risk-based, protocol-driven perioperative management, including escalating levels of care, escalating levels of monitoring, and escalating levels of hospitalist co-management. The set of assessments and interventions in the proposed study are conceptually similar to other "bundled" interventions which have recently been recently tested and demonstrated to reduce perioperative mortality and morbidity.

Perioperative Risk Study

A Randomized Controlled Trial of Perioperative Risk Stratification and Risk-based, Protocol-driven Management in Patients Undergoing Elective Major Cancer Surgery

In patients who are deemed to have no clinical evidence of disease after the index surgery

Fox Chase Cancer Center

Nutritional and Metabolic Diseases

Malnutrition

Abdominal Neoplasms

Nutrition Disorders

Patients are asked to drink two 200ml bottles of nutritional supplement daily

Patients are asked to keep on to their normal diet. No supplementation is introduced

Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery

Nutritional supplements

Paweł Kabata, MD

Tomasz Jastrzębski, Prof

Michał Kąkol, MD

Karolina Król, MSc

Tomasz Jastrzębski, Prof.

The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition

In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications

Nutritional Supplementation in Patients With no Signs of Malnutrition

The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition

The aim of the study was to assess if nutritional supplementation improves nutritional status of patients with no clinical signs of malnutrition. Nutritional status improvement will be assessed by change in anthropometric (body weight (kg)) and laboratory (albumin, total protein, transferrin level, total lymphocyte count) parameters.

To assess if improvement of nutritional status is connected with reduced number of postoperative complications.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Synapse 3D With Intravascular Indocyanine Green	NCT03953144	Non-small Cell ... Primary Neoplas...	Synapse 3D Lung... IC-Green (ICG)	18 Years -	St. Joseph's Healthcare Hamilton
Perioperative Risk Study	NCT02456389	Tumors Primary Neoplas... Secondary Neopl... Surgery	Preoperative ri... Postoperative r... Risk-based, esc... Risk-based, esc... Risk-based, esc... Standard postop...	18 Years -	Fox Chase Cancer Center
Synapse 3D With Intravascular Indocyanine Green	NCT03953144	Non-small Cell ... Primary Neoplas...	Synapse 3D Lung... IC-Green (ICG)	18 Years -	St. Joseph's Healthcare Hamilton
Nutritional Supplementation in Patients With no Signs of Malnutrition	NCT01894828	Primary Neoplas... Secondary Neopl... Abdominal Neopl...	Nutritional sup...	18 Years -	MedSource Polska
Perioperative Risk Study	NCT02456389	Tumors Primary Neoplas... Secondary Neopl... Surgery	Preoperative ri... Postoperative r... Risk-based, esc... Risk-based, esc... Risk-based, esc... Standard postop...	18 Years -	Fox Chase Cancer Center

Spots Global Cancer Trial Database for primary neoplasm