Automatic Segmentation of Polycystic Liver (ASEPOL)

• ClinicalTrials.gov Identifier: NCT03960710
• Recruitment Status: Unknown
• First Posted: May 23, 2019
• Last Update Posted: May 28, 2019
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Study Description

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.

Condition or disease	Intervention/treatment
Polycystic Liver Disease; Polycystic Hepatorenal Disease; Liver Injury	Other: Anonymized CT examinations; Other: Training (1); Other: Training (2); Other: Validation (1); Other: Validation (2)

Study Design

• Study Type: Observational
• Estimated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Automatic Segmentation by a Convolutional Neural Network (Artificial Intelligence - Deep Learning) of Polycystic Livers, as a Model of Multi-lesional Dysmorphic Livers
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: July 2019
• Estimated Study Completion Date: September 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
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 examinations; 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.; Other: Training (1); 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; Other: Training (2); 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 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 examinations; 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.; Other: Validation (1); 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; Other: Validation (2); 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

Outcome Measures

Primary Outcome Measures :

1. Test of automatic segmentation by the convolutional neural network on these group and collection of data set [ Time Frame: At 4 months after randomization ]

   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepato-renal polycystosis, with or without surgery

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Bénédicte CAYOT; 472110400 ext +33; benedicte.cayot@chu-lyon.fr

Contact: Pierre-Jean VALETTE, MD, Prof.; 472117544 ext +33; pierre-jean.valette@chu-lyon.fr

Locations

France

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

Lyon, France, 69437

Contact: Bénédicte CAYOT 472110400 ext +33 benedicte.cayot@chu-lyon.fr

Contact: Pierre-Jean VALETTE, MD, Prof. 472117544 ext +33 pierre-jean.valette@chu-lyon.fr

Principal Investigator: Pierre-Jean VALETTE, MD, Prof.

Sponsors and Collaborators

Hospices Civils de Lyon

More Information

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT03960710
• Other Study ID Numbers: ASEPOL
• First Posted: May 23, 2019
• Last Update Posted: May 28, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Diseases; Digestive System Diseases