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OpenTrials
Completed

NCT Number: NCT02365779

Optical Biopsy and Fallopian Tube

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.

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Key information

Conditions

Bilateral Laparoscopic Salpingectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de Gynécologie, Hôpital Femme Mère Enfant, Lyon

Bron, 69500, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral laparoscopic salpingectomy

Procedure

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

endomicroscopy Cellvizio® system

Device

Primary outcomes

  1. Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation

    Time frame: DAY 1

Secondary outcomes

  1. : Description of the optical biopsy pictures in order to state a classification

    Time frame: DAY 1

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: FALLOPTIC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 19, 2015
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.