Clinical trial NCT04154683: Optical Biopsy in Gynecological Surgery
Official title: Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Surgical Procedures
Keywords: salpingectomy
Cellvizio®
optical biopsy
unilateral or bilateral salpingectomy
ovariectomy
Endometriosis
surgery for cervical
ovarian cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Optical biopsy is a new technology that generates a real-time, cell-based, high-resolution view and analysis of tissues. Observation is instantaneous and non-invasive. This allows reliable and fast diagnosis which facilitates decision making as well as patient management.

The investigator have already conducted a feasibility study on the use of this new technology to evaluate ovarian and tubal pre-cancerous lesions in laparoscopy. In this new study, he wants to continue investigations, expand its use to other gynecological pathologies, and demonstrate the benefit of such a non-invasive technology in gynecology on the one hand in the diagnosis of lesions but also to appreciate the margins as accurately as possible surgical excision of tumors and / or endometriosis lesions.

The investigator have set up a prospective monocentric descriptive study. The hypothesis is that optical biopsy by Cellvizio® allows to observe in real time microscopically tissues and to characterize them in the field of gynecological surgery


Eligibility criteria: Inclusion Criteria:

* Women aged 18 years or more
* Informed and signed consent
* Planned surgery under laparoscopy and included in the list below:

  * unilateral or bilateral salpingectomy
  * hysterectomy
  * ovariectomy
  * surgery of endometriosis
  * surgery for cancer of the cervix, endometrium, ovaries

Exclusion Criteria:

* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* Pregnancy or desire of pregnancy during the study period, breastfeeding
* Hypersensitivity to Fluorescein or any of its excipients
* History of life-threatening reaction during angiography
* Known allergic reactions and hypersensitivity
* Severe asthma, heart and / or lung disease, diabetes
* Person on beta-blocker treatment
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision

Primary outcomes:
measure: correlation optical biopsy and anatomopathology
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
city: Bron
country: France
facility: Service de Gynécologie, HFME, Hospices Civils de Lyon
Study officials:
affiliation: Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civils de Lyon
name: Gautier CHENE, MD
role: PRINCIPAL_INVESTIGATOR
References: