Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.
Most of ovarian carcinomas related to BRCA 1 or 2 mutations are of fallopian tube origin and especially from its distant part called the fimbria. These tubal, ovarian or primary peritoneal carcinomas are quite always of high grade serous type. They cannot be effectively screened due to the quickness of their evolution. In this context, a laparoscopic bilateral salpingo-oophorectomy (BSO) is the recommended prophylactic procedure. Some BRCA-mutated women are reluctant to undergo this procedure considering the numerous adverse effects on body and quality of life, especially when hormonal replacement is forbidden. This refusal makes them at risk of developing a serous pelvic carcinoma. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
123
Laparoscopic bilateral radical fimbriectomy : Complete resection of the tubes, from the uterine tube (up against the uterus) to the fimbriae, with resection of the part of the ovary adjacent to the ovarian fimbriae (adhering to the ovary)
Anatomopathological study of surgical specimens
Polyclinique du Parc Rambot
Aix-en-Provence, France
Institut Bergonié
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Rate of pelvic cancer
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
Time frame: an expected average of 15 years
Morbidity associated with the radical prophylactic fimbriectomy
Morbidity will be assessed according to the Clavien-Dindo classification up to 30 days after the procedure and according to the NCI-CTCAE v4.0 grading scale beyond that time
Time frame: Up to 30 days after the surgery
Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens
Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens
Time frame: Within 1 month after fimbriectomy, and within 1 month after oophorectomy
Incidence of breast cancer on patients without breast cancer before fimbriectomy, and incidence (de novo or recurrence) of breast cancer on the overall study population
Number of cases of breast cancer or breast cancer recurrence observed
Time frame: an expected average of 15 years
Rate of secondary oophorectomies and associated morbidity, and reasons for oophorectomy if decided before the age of 50 et before menopausis
Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale
Time frame: an expected average of 15 years
Proteomic profile of tissues from radical fimbriectomy
Immunostaining is realised on sections of ovary portion, fimbriae and fallopian tubes, then tumoral zones are selected for spatially resolved gun microproteomic analysis
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Centre Oscar Lambret
Lille, France
CHR-U
Lille, France
Clinique du Bois - Bourgogne Center
Lille, France
Hospices Civils de Lyon
Lyon, France
Institut Paoli Calmettes
Marseille, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
...and 4 more locations
Time frame: Up to 7 years after sample collection
Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40)
Number of cases of menopausis an early menopausis observed
Time frame: an expected average of 15 years
Proportion of benign histological abnormalities on radical Fimbriectomy specimens
Number of benign histological abnormalities on the operative specimens
Time frame: Within 1 month after fimbriectomy
Patient's satisfaction at distance from Radical Fimbriectomy
Patient satisfaction survey
Time frame: Up to 10 years