Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer
NCT02570815
Summary
Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform 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. 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. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed. Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to determine which segment the tumour is located in. Once identified, the surgeon will isolate the segment by cutting off the blood supply to that segment. Then ICG will be injected into a vein. It is expected that the entire lung, except the isolated segment, which will remain 'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will remove it. A pathologist will examine the excised tissue to ensure that the tumour was removed in its entirety. Once confirmed, the surgeon will end the procedure. If the pathologist determines that the segment removed did not contain the entire tumour, then the surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all participants will have the entire tumour removed from their lung.
Eligibility
Inclusion Criteria: 1. Age \> 18 years 2. Tumor size \<3 cm 3. Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC) 4. CT-imaging confirming that the tumour is confined to the one broncho-pulmonary segment, rendering the patient a candidate for segmental resection. Exclusion Criteria: 1. Hypersensitivity or allergy to ICG, sodium iodide or iodine 2. Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.
Conditions3
Interventions1
Related trials
- Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery — Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery — Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study — Jules Bordet Institute
- Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer — Isabelle Henskens
- Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery — Gustave Roussy, Cancer Campus, Grand Paris
- The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound. — Hospital Universitari Vall d'Hebron Research Institute
- A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer — University of Florida
- Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors — St. Jude Children's Research Hospital
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT02570815