Optical Biopsy and Fallopian Tube

Not Applicable

Completed

• Conditions: Bilateral Laparoscopic Salpingectomy
• Interventions: Procedure: bilateral laparoscopic salpingectomy; Device: endomicroscopy Cellvizio® system

• Registration Number: NCT02365779
• Lead Sponsor: Hospices Civils de Lyon

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

Basic Information
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Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-11
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-19
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bilateral laparoscopic salpingectomy	bilateral laparoscopic salpingectomy	-
bilateral laparoscopic salpingectomy	endomicroscopy Cellvizio® system	-

Primary Outcome Measures

Name	Time	Method
Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation	DAY 1

Secondary Outcome Measures

Name	Time	Method
: Description of the optical biopsy pictures in order to state a classification	DAY 1

Trial Locations

Locations (1)

Service de Gynécologie, Hôpital Femme Mère Enfant, Lyon; 🇫🇷 Bron, France