Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts

Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts

Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.

The experimental arm is only sentinel node identification + radical hysterectomy.

Inclusion Criteria:

• Women 18 years of age or older,
• Absence of contraindication to laparoscopy,
• Uterine cervical carcinoma (every histological type except neuroendocrine),
• Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),
• Negative pregnancy test for women able to procreate,
• Having the French National Social Security
• Signed informed consent

Exclusion Criteria:

• Neuroendocrine carcinoma,
• In situ carcinoma or stage IA1 without LVSI,
• Maximal tumoral diameter measured by MRI more than 4 cm,
• Stage IB1 by "down-staging",
• Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,
• Presence of distant metastases,
• Progression of the cervical cancer or recurrence,
• History of pelvic lymphadenectomy,
• Other cancer diagnosed during the course of treatment,
• Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide,
• History of severe allergy (history of Quincke's edema, anaphylactic shock),
• Patient who does not understand, speak or write the French language,
• Pregnant woman