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FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in Europe since December 2003 and is currently used in many countries. FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM).
Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver fibrosis.
Some other studies have already shown the good correlation between LSM, assessed by FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).
PHT is a clinical condition characterized by a high blood pressure in the portal vein and its tributaries and it is defined as a gradient between portal and systemic blood pressure > 6 mmHg.
The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential bleeding, represent one of the most severe and life-threatening complication of cirrhosis.
Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices or congestive gastropathy, for estimating the grade of OV and for the recognition of the presence of red color signs and wale marks or other indicators of high risk for bleeding.
However these two methods are quite invasive and associated with some risks; at the same time, not all cirrhotic patients present OV at endoscopic screening.
The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence of OV in liver cirrhosis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibroscan® | Other | Fibroscan® is an active non implantable medical device using ultrasound. It has been designed to measure liver stiffness in a painless, rapid and non invasive manner. It is a diagnostic aid tool. In this study, Spleen Stiffness Measurement will be assessed using a dedicated FibroScan® device which has been developed specifically to assess spleen stiffness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroscan® examination | Device | Each patient undergo 1 LSM and at least 1 SSM (2 in more if the patient accept to participate at the ancillary study (intra and inter operator reproducibility of SSM). |
| Measure | Description | Time Frame |
|---|---|---|
| Selection of patient with cirrhosis using LSM ≥ 14 kPa (kilopascal) | Up to 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of large OV with an sensitivity of 95% and an acceptable lower bound of 85% | Up to 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of patients with large OV in cirrhotic patients: 30% | Up to 36 month |
Inclusion Criteria:
All groups
Case group
Control groups
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davide FESTI, Pr. | Department of Clinical Medicine, Policlinico S. Orsola Malpighi, Bologna, Italy | Principal Investigator |
| Horia STEFANESCU, Dr. | Iuliu Hatieganu University of Medicine and Pharmacy, Clu-Napoca, Romania | Principal Investigator |
| Victor de LEDINGHEN, Pr. | Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive, Pessac, France | Principal Investigator |
| Paul CALES, Pr. | CHU, Service Hépato-gastroentérologie, Angers, France | Principal Investigator |
| Mirella FRAQUELLI, Dr. | Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milano, Italy | Principal Investigator |
| Nathalie CARRIE-GANNE, Pr. | Hôpital Jean Verdier, Service Hépato-gastroentérologie, Bondy, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU, Service Hépato-gastroentérologie | Angers | 49933 | France | |||
| Hôpital Jean Verdier, Service Hépato-gastroentérologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31444849 | Derived | Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D004932 | Esophageal and Gastric Varices |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Bondy |
| 93140 |
| France |
| Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive | Pessac | 33604 | France |
| Department of Clinical Medicine, Policlinico S. Orsola Malpighi | Bologna | 40138 | Italy |
| Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, | Milan | 20122 | Italy |
| Iuliu Hatieganu University of Medicine and Pharmacy | Cluj-Napoca | 400162 | Romania |
| Royal Free Hospital, Pond Street | London | NW3 2QR | United Kingdom |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |