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Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study

NCT02552004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-03-22

No results posted yet for this study

Summary

Intraoperative histological examination is a fundamental tool in surgery. Probe-based Confocal Laser Endomicroscopy (pCLE) is a new imaging technique which enables real-time, microscope-resolution imaging, currently used in endoscopy. This pilot study aims to evaluate pCLE in surgical setting. The objective is the depiction of histological rendering of normal and pathological tissues through pCLE. Feasibility of real-time diagnosis will also be assessed. All surgical conditions usually necessitating frozen section will be investigated. A total of 30 patients, with various pathology of the thyroid / parathyroid, stomach, esophagus, pancreas, adrenal, colon / small intestine, liver will be included. Diagnostic criteria will be defined by a surgeon - pathologist team and further validated by retrospective analysis of the video sequences in comparison to conventional histology slides. The data will be used to create an image bank of reference optical biopsy images. The study will allow to point out the surgical conditions in which pCLE is the most effective and reliable and could eventually replace the frozen section technique.

Conditions

  • All Surgical Conditions Usually Necessitating Frozen Section
  • Malignant Tumor
  • Inflammatory Disease
  • Benign Tumor

Interventions

DEVICE

pCLE

Histological examination by pCLE technique preceding the frozen section

DRUG

IV fluorescein administration

IV Fluorescein (fluorescent contrast agent) administration

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Mihaela Ignat, MD, PhD · Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil - Strasbourg

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-13
Primary Completion
2017-12-14
Completion
2018-02-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02552004 on ClinicalTrials.gov