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.
Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months
Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery
Uterine Cervical Dysplasia
identification of sentinel nodes + full pelvic lymph-node dissection
Study Arms / Comparison Groups
Description: Only identification of sentinel nodes (without pelvic lymph-node dissection)
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
18 Years - N/A
Accepts Healthy Volunteers
Hospices Civils de Lyon