NCT03718078

Brief Summary

This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

October 23, 2018

Last Update Submit

January 23, 2019

Conditions

HepatocarcinomaHepatic MetastasisHepatic Tumor

Outcome Measures

Primary Outcomes (1)

  • malignant pCLE criteria

    Definition of pCLE criteria for normal and malignant hepatic tissues

    1 year

Secondary Outcomes (6)

  • pathological pCLE criteria

    1 year

  • Ease of use of the endomicroscopy device

    1 year

  • Audio/video telecommunication quality

    1 year

  • Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0

    1 year

  • Stability and reproducibility of images/sequences during procedures

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Confocal Laser Endomicroscopy

EXPERIMENTAL

lt includes patients will undergo probe-based Confocal Laser Endomicroscopy during laparoscopic hepatic masses resection.

Device: Confocal Laser Endomicroscopy

Interventions

Confocal Laser EndomicroscopyDEVICE

The study is divided in two parts. For the two parts, patients will receive an intravenous injection of indocyanine green: 1. Ex vivo study \- Images/sequences of normal and abnormal hepatic tissues and surgical margins will be acquired on surgical specimens 2. In vivo study - Intra-operative pCLE imaging will be performed on hepatic masses and surgical margins

Also known as: probe-based Confocal Laser Endomicroscopy, CelioFlex UHD 5 probe, Viziobot-P, GastroFlex UHD probe, Cellvizio 100 series, pCLE, Confocal Miniprobes
Confocal Laser Endomicroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years
  • Scheduled for a surgical resection of hepatic masses
  • Provided signed informed consent

You may not qualify if:

  • Allergy to Indocyanine green (ICG)
  • Kidney failure
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 24, 2018

Study Start

March 1, 2019

Primary Completion

January 7, 2020

Study Completion

January 7, 2020

Last Updated

January 24, 2019

Record last verified: 2019-01

Locations

FR(1)