None listed
Conditions
Brief summary
This study will assess the use of a dye (indocyanine green or ICG) to identify lymph nodes within the oesophagus and stomach during surgery to remove lymph nodes in patients with stomach and/or oesophageal cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with oesophagus, gastro-oesophageal junction and/or stomach cancer and you will be undergoing surgery as the primary treatment for your cancer. Study details All participants who choose to enrol in this study will have an additional step of a dye injection (ICG) at the start of surgery. The planned surgery will then be conducted as per usual process with as many lymph nodes removed as are identified. At the end of the surgery, the surgeon will then use a near-infrared camera to scan the tissue to identify and remove any additional lymph nodes containing ICG in the surgical field. It is hoped this research will determine whether a greater number of lymph nodes can be identified and removed with the ICG dye and camera scanning compared to usual care. If this method is found to be more successful at identifying and removing lymph nodes for patients with oesophageal and stomach cancers, it may be included in the usual care practices to improve outcomes for future cancer patients.
Interventions
This study is a multi-centre prospective cohort study (interventional) assessing if indocyanine-green can increase lymph node yield during surgery for oesophageal and gastric cancer.
Indocyanine green is a water soluble, tricarbocyanine dye with peak spectral absorption at 800 nm.
The chemical name for Indocyanine green is 1 H-Benz[e]indolium,2-[7[1,3-dihydro-1,1-dimethyl-3-(-4-sulfobutyl)-2H-benz[e]indo-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide, innersalt, sodium.
This study is a multi-centre prospective cohort study (interventional) assessing if indocyanine-green can increase lymph node yield during surgery for oesophageal and gastric cancer. Indocyanine green is a water soluble, tricarbocyanine dye with peak spectral absorption at 800 nm. The chemical name for Indocyanine green is 1 H-Benz[e]indolium,2-[7[1,3-dihydro-1,1-dimethyl-3-(-4-sulfobutyl)-2H-benz[e]indo-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide, innersalt, sodium. 2-[7-[1,1-Dimethyl-3-(4-sulfobuttyl)benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-1Hbenz[e]indolium hydroxide. Indocyanine green is approved by the FDA and is accessible for intra-operative diagnostic use in Australia under the TGA special access scheme. During the intervention phase, all participants will receive ICG on the day of surgery. Indocyanine green is administered at the commencement of surgery via endoscopy. A surgeon trained to perform the procedure will administer indocyanine green. A single delivery of four 0.5ml injections of 0.312mg/ml indocyanine green (total of 0.625mg) is administered submucosally around the tumour in quadrants. Indocyanine green will diffuse to lymph nodes via lymphatic channels. At the conclusion of standard of care surgery, a near-infrared camera will be used to identify and remove any additional lymph nodes containing ICG in the surgical field. The number of additional nodes identified with indocyanine green will be compared to the number of lymph nodes removed without indocyanine green identification and analysed for the presence of metastasis. Routine surgery, depending on the case type is anticipated to take between 4-6 hours. The use of ICG and indocyanine green is anticipated to add 15 minutes to the overall case. Strategies to monitor adherence to the intervention include review of operative photos that will be taken of the surgical field and the specimen at the end of routine surgery, and the operation report.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with cancers of the oesophagus, gastro-oesophageal junction and stomach who are undergoing curative-intent surgery. 2. Patients undergoing the following operations: • Ivor-Lewis (two-stage) oesophagectomy • McKeown (three-stage) oesophagectomy • Proximal partial oesophago-gastrectomy • Extended total gastrectomy • Total gastrectomy • Subtotal gastrectomy
Exclusion criteria
1. Patient declined participation in study 2. Known allergy to indocyanine green, sodium iodide or iodine. 3. Evidence of thyroid nodules on physical examination or on standard of care staging PET/CT scan 4. Biochemical evidence of hyperthyroidism from thyroid function tests (TFT) 5. Patient’s receiving concurrent radioactive iodine treatment for thyroid disease 6. Patients with Stage IV cancer (AJCC 8th edition) 7. Stage IV and V kidney failure 8. Pregnancy and breastfeeding
Outcome results
None listed