A Prospective Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial Cancer

Uterine cancer is the most common gynecologic malignancy in developed countries. Adenocarcinoma of the endometrium is the most common histologic type of uterine cancer. Endometrial cancer is the fifth most frequent cancer in women in Switzerland. The incidence rose up to 5.9% in 2015. This tumor affects mainly older women, at 63 years on average. The majority of women are diagnosed at an early stage. Seventy-five to 90% of the patients are alerted by abnormal uterine bleeding very quickly, which allows a quick management of care and a high survival rate. Besides age, one of the main risk factor of developing an endometrial carcinoma is obesity. In fact, obese women have higher risk to have an endometrial cancer, but also at a younger age than the average and finally they have an increased risk of death due to this particular cancer. Although this cancer is linked to the co-morbidities that go with obesity like diabetes or hypertension. The treatment of endometrial cancer in most women is surgery involving a total hysterectomy and a bilateral salpingo-oophorectomy with or without a lymph node dissection. For patients with early stage endometrial cancer, there is a disagreement regarding lymph nodes dissection, because randomized controlled trials and a meta-analysis have shown no clear evidence on overall or recurrence-free survival and a higher incidence on early and late complications in relation with pelvic lymph node dissection. A systematic lymph node dissection consists of removing all the nodes within a nodal drainage basin. This dissection proves to be very difficult in obese patient and includes a risk to damage blood vessels or nerves. Moreover, lymph node dissection is associated with a higher morbidity, longer operating time, more frequent blood loss and finally symptomatic lymphedema and seroma. That is why, sentinel lymph node biopsy (SLNB) seems to be a good alternative to lymph node dissection. The tumor's spread is assessed in lymph nodes with a reduced morbidity. In fact, lymphadenectomy and its dangerous complications, like lymphedema, could be avoided in the vast majority of cases. Indeed, a histological analysis of these sentinel lymph-nodes (SLNs) leads to ultrastadification: cancers are graded depending on the presence and the size of metastasis in lymph nodes. Adjuvant treatments, such as radiotherapy or chemotherapy, can be suggested following these data and a better management of endometrial cancer is possible.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Informed Consent as documented by signature
* Early endometrial cancers (of International Federation of Gynecology and Obstetrics stage IA-IB), whatever histological grade and type
* Primary surgical treatment with hysterectomy
* No metastasis, no other cancers, no recurrency of cancers
* No signs of lymph nodes metastasis on the preoperative workup (MRI +/- positron emission computed tomography)
* No contraindication to laparoscopic procedures.
* Women of \> 18 years

Exclusion Criteria:

* Known severe allergies (antecedents of Quincke oedema, anaphylactic shock,…) and a history of allergy to iodides
* Contraindications to the injected products because of known hypersensitivity or allergy to ICG of blue dye
* Antecedent of pelvic lymph nodes surgery
* Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage (conisation or myomectomy)
* Other diagnosed cancer during treatment or care
* Stage II and above (tumor invading cervix stroma) including those after a neo-adjuvant treatment
* Suspicion of lymph nodes metastasis at preoperative workup
* Medical or uterine conservative treatment
* Patient, who does not understand, speak or write in French
* Drugs that can interfere with ICG : anti convulsants - bisulphite compounds - haloperidol - heroin - pethidine \[meperidine\] - methamizole - methadone - morphine - nitrofurantoin - opium alkaloids - phenobarbitone- phenylbutazone - cyclopropane - probenecid - rifamycin - sodium bisulphite (mostly combined with heparin)
* Radioactive iodine uptake performed less than one week following the use of ICG.
* Hypersensitivity to Nanocoll, to any of the excipients (Stannous chloride, dihydrate Glucose, anhydrous Poloxamer 238 Sodium phosphate, dibasic, anhydrous Sodium phytate, anhydrous) or to any of the components of the labelled radiopharmaceutical.
* A history of hypersensitivity to products containing human albumin
* Hypersensitivity to dyes made of triphenylmethane
* Lymphostasis