Optical Biopsy and Fallopian Tube

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Salpingectomy on Ovarian Reserve

NCT02284711

Laparoscopic Salpingectomy

COMPLETED NA

Radical Fimbriectomy for Young BRCA Mutation Carriers

NCT01608074

BRCA1 Mutation BRCA2 Mutation Hereditary Breast and Ovarian Cancer

ACTIVE_NOT_RECRUITING NA

Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy

NCT01247779

Cervical Cancer Uterus Cancer Ovarian Cancer

COMPLETED NA

Low Grade Serous Ovarian Carcinoma and Uterine Involvement : Should Hysterectomy be the Rule

NCT05741554

Serous Ovarian Carcinoma Low Grade Serous Ovarian Carcinoma

COMPLETED

Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology

NCT03187327

Salpingectomy Hysterectomy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bilateral Laparoscopic Salpingectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bilateral laparoscopic salpingectomy

Group Type EXPERIMENTAL

bilateral laparoscopic salpingectomy

Intervention Type PROCEDURE

Use of the confocal laser endomicroscopy Cellvizio® system during laparoscopy salpingectomy

endomicroscopy Cellvizio® system

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bilateral laparoscopic salpingectomy

Use of the confocal laser endomicroscopy Cellvizio® system during laparoscopy salpingectomy

Intervention Type PROCEDURE

endomicroscopy Cellvizio® system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No