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Completed

NCT Number: NCT02312167

Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)

This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).

Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.

The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.

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Key information

Conditions

Cancer of Digestive System Adnexal Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Duodenal Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Rectal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mutualiste Montsouris Institute

Paris, 75014, France

About this study

This study involves several innovations including :

  • the robotization of the confocal miniprobe for a better an d more precise handling of the probe
  • the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)
  • the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
  • patient able to give written informed consent

Exclusion criteria

  • allergy to fluorescein
  • allergy to patented blue
  • allergy to ICG
  • previous life-threatening allergic reactions and known hypersensitivity
  • pregnancy or breast-feeding
  • history of cardio-pulmonary disease (including bronchial asthma)
  • restricted renal function
  • patient under a beta-blockers treatment
  • patient who cannot give written informed consent

Treatment and study plan

Confocal Laser Endomicroscopy

Device

probe-based and needle-based confocal laser endomicroscopy

Other names: optical biopsy, Cellvizio

Primary outcomes

  1. The number of participants with adverse events, their type and severity

    Time frame: 8 months

Secondary outcomes

  1. The ease of manipulation of the robotized probe (grade 1 to 5)

    Time frame: 8 months

    during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device

Other outcomes

  1. the quality of real time communication between the pathologist lab and the OR (grade 1 to 5)

    Time frame: 8 months

    during or after each procedure, the surgeon and the pathologists are asked to assess the quality of audiovisual communication

  2. number of interpretable images per organ, per contrast agent and per pathology

    Time frame: 8 months

    each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc ...). Thanks to this, a more complete atlas of images obtained in digestive organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators, the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Collaborators

  • Mauna Kea Technologies

Registry information

Official study title

Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE

Acronym: PERSEE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2014
Registry last updated
Feb 11, 2016

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.

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