Optical Biopsy and Fallopian Tube

Study Overview
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Brief Summary
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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
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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

Official Title
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Dynamic Real-time in Vivo Confocal Laser Endomicroscopy Cellvizio® of the Fallopian Tube During Laparoscopy

Conditions
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Bilateral Laparoscopic Salpingectomy

Intervention / Treatment
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* Procedure: bilateral laparoscopic salpingectomy
* Device: endomicroscopy Cellvizio® system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bilateral laparoscopic salpingectomy<br> | Procedure: bilateral laparoscopic salpingectomy<br>* Use of the confocal laser endomicroscopy Cellvizio® system during laparoscopy salpingectomy<br>Device: endomicroscopy Cellvizio® system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation |  | DAY 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| : Description of the optical biopsy pictures in order to state a classification |  | DAY 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salpingectomy, optical biopsy, Cellvizio®