Clinical trial NCT02365779: Optical Biopsy and Fallopian Tube
Official title: Dynamic Real-time in Vivo Confocal Laser Endomicroscopy Cellvizio® of the Fallopian Tube During Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Laparoscopic Salpingectomy
Keywords: salpingectomy
optical biopsy
Cellvizio®
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with an important mortality due to late diagnosis. However the prognosis is excellent in the early stages of the disease. Recently it has been described a new serous carcinogenic sequence from the fallopian tube with tubal precancerous lesions. Therefore the identification of these early preinvasive lesions would be of great interest in the population with hereditary predisposition for ovarian cancer (concept of oncofertility) and in the general population (to determine whether bilateral salpingectomy has to be performed during a hysterectomy for benign disease).

The optical biopsy has been developed and validated in the detection of early precancerous lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the study of fallopian tubes during laparoscopy with correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation. The second objective is to describe the optical biopsy pictures in order to state a classification.

Detailed description: Inclusion Criteria:

* Woman aged 18 years or more
* All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
* Informed and signed consent

Exclusion Criteria:

* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* Pregnancy, ongoing or planned during the study period
* Allergy to fluorescein
* Previous allergy or anaphylactic shock during an angiography
* Allergic or hypersensibility reactions
* Severe asthma, chronic cardiac or pulmonary diseases
* Restricted renal function
* Patient under a beta-blockers treatment
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision

Eligibility criteria: Inclusion Criteria:

* Woman aged 18 years or more
* All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
* Informed and signed consent

Exclusion Criteria:

* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* Pregnancy, ongoing or planned during the study period
* Allergy to fluorescein
* Previous allergy or anaphylactic shock during an angiography
* Allergic or hypersensibility reactions
* Severe asthma, chronic cardiac or pulmonary diseases
* Restricted renal function
* Patient under a beta-blockers treatment
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision

Primary outcomes:
measure: Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation
timeFrame: DAY 1
Secondary outcomes:
measure: : Description of the optical biopsy pictures in order to state a classification
timeFrame: DAY 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Gynécologie, Hôpital Femme Mère Enfant, Lyon
Study officials:
References: