None listed
Conditions
Brief summary
This study aims to prospectively collect clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand. You may be eligible to join this study if you are a female aged 18 years or above with histologically confirmed, unifocal invasive squamous cell carcinoma of vulva less than 4cm in greatest dimension. Women in Australia and New Zealand women with early vulval cancer will be offered sentinel node procedures in place of groin node dissection. On the day before or the morning of your operation, you will have a small injection of a radioactive marker into the skin next to the cancer. A local anaesthetic cream will be used to reduce any discomfort from this injection. Pictures will then be taken over the next 2 1/2 hours to see which glands the marker has spread to. The marker will also help us find the ‘sentinel nodes’ during your operation. Either on the afternoon after the injection or the next day you will have your operation as planned by your doctor. Whilst you are asleep we will inject some blue dye around the cancer which will also help us to identify the sentinel glands. During the 60 minute operation we will remove the cancer. We will identify and remove the sentinel lymph gland(s) from one or both groins. When sentinel nodes in one or two groins can not be identified a full removal of the groin nodes (lymphadenectomy) on either one or both sides will be performed. The gland(s) will be sent to the laboratory for detailed assessment by the pathologist. Follow up clinical data will be collected from your clinical records at 3, 12, and 24 months after surgery (and at, 36, 48, and 60 months where possible), from information obtained when you attend outpatients clinic. The majority of women with early vulval carcinoma do not have groin node metastasis and these women are unlikely to benefit from groin node dissection. The use of sentinel node dissection is safe and should be part of the standard treatment for women with early stage vulvar cancer.
Interventions
Prior to the operation and following application of emlar cream, 0.2-0.6 ml of 60-MBq technetium-99m–labeled nanocolloid (or similar) is injected by the surgeon intradermally in 4 locations around the primary tumour (0.05 ml each in each site) or clearly identifiable scar from recent excision biopsy. XRay pictures are then taken over the next 2 1/2 hours to identify the first appearing persistent focal accumulation or sentinel node. The site of the sentinel node is marked on the overlying skin.
Prior to the operation and following application of emlar cream, 0.2-0.6 ml of 60-MBq technetium-99m–labeled nanocolloid (or similar) is injected by the surgeon intradermally in 4 locations around the primary tumour (0.05 ml each in each site) or clearly identifiable scar from recent excision biopsy. XRay pictures are then taken over the next 2 1/2 hours to identify the first appearing persistent focal accumulation or sentinel node. The site of the sentinel node is marked on the overlying skin. On the day or the afternoon after the injection of the radioactive tracer, following induction of anesthesia for surgery, approximately 0.5-1.0 ml of the blue dye (eg. Patente blue-V) is injected intradermally on the same 4 locations around the primary tumor approximately 5-10 minutes prior to the surgical procedure. The surgical procedure starts with identification and removal of the sentinel nodes. During the operation a handheld gamma-ray-detection probe is used to confirm the marked area of greatest activity in the groin. A small skin incision is made at the marked spot and a sentinel node excision biopsy is performed using the handheld gamma-ray detector and by dissection of blue-stained lymph vessels. Sentinel nodes are sent to the pathologist. Subsequently resection of the vulvar lesion is performed. Participation in this study is entirely voluntary. If women do not wish to take part in this study, they will receive one standard management of early vulval carcinoma which is wide excision or vulvectomy and removal of all groin nodes.
Sponsors
University Of Otago Christchurch
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. Able to give informed consent. 2. Early vulval carcinoma confirmed histologically (unifocal, invasive squamous cell carcinoma less than 4cm in greatest dimension - not including insitu component) 3. Depth of invasion greater than 1mm
Exclusion criteria
1. Tumour involves urethra, anus or middle 1/3 of vagina. 2. Reconstruction of the vulva using a flap has been performed with removal of the primary lesion . 3. Clinical evidence of groin node metastasis.(palpation, imaging , FNA) 4. Prior history of SCC of the genital tract, anus, or lower body. 5. Prior groin node dissection
Outcome results
None listed