The proportion of patients with a positive sentinel lymph node( at least one macro- or micrometastasis) which alter the adjuvant therapy
ID
Bron
Verkorte titel
Aandoening
Endometrial cancer (early stage)
Sentinel lymph node
Indocyanine green
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The proportion of patients with a positive sentinel lymph node ( at least one macro- or micrometastasis) with a change in adjuvant therapy.
Achtergrond van het onderzoek
The treatment of endometrial cancer (EC) is primarily surgery (removal of uterus and adnexa). There is an ongoing controversy in the management of EC relates to lymphadenectomy. Randomized trials and a meta-analysis have shown that pelvic lymphadenectomy has no effect on overall or recurrence-free survival, but can lead to longer operation time and morbidity [Kitchener et al. 2009, Benedetti et al. 2008, May et al. Cochrane Rev 2010] However, the trials on lymphadenectomy in early stage endometrial cancer did not take into account the contribution of sentinel lymph node (SLN) biopsy in reducing the risk of surgical complications and improving staging.
Recent studies showed that SLN biopsy with ultra-staging upstaged 10% of patients with presumed low-risk and 15% of patients with presumed intermediate risk [Ballister et al. 2008, 2011;Abu Rustum 2014]. As involvement of lymph nodes has been proven to be one of the most important prognostic factors in other malignant tumors, SLN biopsy might be a good compromise between systemic lymph node dissection and no node dissection in women with low- or intermediate-risk EC.
When the lymph node status is unknown, indications for adjuvant therapies are on pathological features of surgical specimen of the primary tumor, exposing some patients to overtreatment and undertreatment. Introducing SNP in the treatment of EC will lead to only giving adjuvant treatment when women are truly at risk.
SLN biopsy in EC can be performed with cervical injection prior to surgery using indocyanine green with high detection rates 92-96% and negative predictive values 98-99%.
Doel van het onderzoek
The proportion of patients with a positive sentinel lymph node( at least one macro- or micrometastasis) which alter the adjuvant therapy
Onderzoeksopzet
Histological evaluation of the sentinel lymph node with ultrastaging and immunohystochemistry after surgery.
Onderzoeksproduct en/of interventie
sentinel lymph node before the operation (hysterectomie and adnexa)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age 18 years
Histological confirmed endometrioid adenocarcinoma of the endometrium grade 1 or 2 on microcurettage
Low-risk: type 1 endometrial cancer, stage IA grade 1 or 2 or Intermediate-risk: type 1 endometrial cancer, stage IB grade 1 or 2
WHO-performance 0-2
WBC > 3.0x 109/L, platelets > 100 x 109/L, creatinine clearance > 60ml/min
CT-scan with no evidence of distant metastases
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients with high-risk type 1 endometrial cancer stage (IB grade 3) or type 2 endometrial cancer (defined as > 10% of the specimen is serous or clear cell type) of any grade and stage.
Patients with intermediate- risk stage IA grade 3 type 1 endometrial cancer
Patients with contraindications to surgery, anesthesia or pelvic radiation.
Patients with an allergic reaction on Technetium 99m-Nanocolloid, ICG or patent-blue
Patients with previous pelvic or para-aortic lymph node dissection or sampling for a previous malignancy
Previous pelvic or abdominal radiotherapy
Patients with evidence of pelvic and/or distant metastasis
Pregnancy
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5659 |
NTR-old | NTR5794 |
CCMO | NL49827.091.14 |