NCT03960710

Brief Summary

Assessing the volume of the liver before surgery, predicting the volume of liver remaining after surgery, detecting primary or secondary lesions in the liver parenchyma are common applications that require optimal detection of liver contours, and therefore liver segmentation. Several manual and laborious, semi-automatic and even automatic techniques exist. However, severe pathology deforming the contours of the liver (multi-metastatic livers...), the hepatic environment of similar density to the liver or lesions, the CT examination technique are all variables that make it difficult to detect the contours. Current techniques, even automatic ones, are limited in this type of case (not rare) and most often require readjustments that make automatisation lose its value. All these criteria of segmentation difficulties are gathered in the livers of hepatorenal polycystosis, which therefore constitute an adapted study model for the development of an automatic segmentation tool. To obtain an automatic segmentation of any lesional liver, by exceeding the criteria of difficulty considered, investigators have developed a convolutional neural network (artificial intelligence - deep learning) useful for clinical practice.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

May 21, 2019

Last Update Submit

May 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Test of automatic segmentation by the convolutional neural network on these group and collection of data set

    Development of an automatic segmentation tool for highly dysmorphic polycystic livers as a prerequisite for segmentation of any type of multi-lesional livers that are difficult to segment, in order to facilitate lesion detection and volume measurement in clinical practice. Randomisation of the patient into two data groups, one for training the other for Validating the convolutional neural network (artificial intelligence) * Manual segmentation of polycystic livers of the 1st training group and deep learning of convolutional neural network * Manual segmentation of polycystic livers of 2nd validation group * Test of automatic segmentation by the convolutional neural network on these group and collection of data set

    At 4 months after randomization

Study Arms (2)

Neuronal network Training group

The following radiological variables, related to each CT examinations, will be collected for each patient: * Injection modalities (without injection, injected) * Major hepatectomy surgery * Importance of hepatic dysmorphia * Presence of intraperitoneal fluid effusion * Presence of renal polycystosis (especially on the right side).

Other: Anonymized CT examinationsOther: Training (1)Other: Training (2)

Neuronal network Validation group

The following radiological variables, related to each CT examinations, will be collected for each patient: * Injection modalities (without injection, injected) * Major hepatectomy surgery * Importance of hepatic dysmorphia * Presence of intraperitoneal fluid effusion * Presence of renal polycystosis (especially on the right side).

Other: Anonymized CT examinationsOther: Validation (1)Other: Validation (2)

Interventions

The anonymized CT examinations will be reviewed in Lyon, in the imaging department of Edouard Herriot Hospital, by an expert radiologist and an intern from the Lyon hospitals.

Neuronal network Training groupNeuronal network Validation group

An initial training phase of the artificial intelligence network will be carried out : \- Segmentation of the livers of a first part of the CT examination, by an intern of the Lyon hospitals

Neuronal network Training group

An initial training phase of the artificial intelligence network will be carried out : \- Use of computer data to drive the artificial intelligence network.

Neuronal network Training group

A validation phase of the artificial intelligence tool will be carried out with segmentation of the livers of the second part of the CT examinations : \- Carried out by an intern at the Lyon hospitals

Neuronal network Validation group

A validation phase of the artificial intelligence tool will be carried out with segmentation of the livers of the second part of the CT examinations : \- Carried out by the neural network

Neuronal network Validation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hepato-renal polycystosis, with or without surgery

You may qualify if:

  • Patients ≥ 18 years old
  • Patients with hepato-renal polycystosis, with or without surgery
  • Patients with at least one abdominal-pelvic CT scan without injection or with injection between January 1, 2016 and August 2018
  • Patients with good quality and available images

You may not qualify if:

  • Patients with no CT scan images available
  • Patients with bad quality of CT scan images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de radiologie - Pavillon B - Cellule Recherche imagerie, Hôpital Edouard Herriot (HCL)

Lyon, 69437, France

RECRUITING

MeSH Terms

Conditions

Polycystic liver disease

Central Study Contacts

Bénédicte CAYOT

CONTACT

Pierre-Jean VALETTE, MD, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

April 1, 2019

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations