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Non-invasive Methods and Surg...

Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-30

Study Completion Date

2022-08-31

Brief Summary

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The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.

Detailed Description

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In the last years, the life expectancy of ACLD patients has increased due to the improvement of the therapeutic strategies of the complications of cirrhosis. .Although surgical procedures have become less invasive the mortality rate in ACLD patients undergoing extrahepatic surgery remains high. For these reasons, an accurate prediction of operative risk for patient-tailored surgical planning becomes crucial.

Purpose of the study: To evaluate the prognostic role of portal hypertension by non- invasive methods in predicting post-operative complications in ACLD patients undergoing elective extrahepatic surgery.

Study type: An international multicenter, prospective, uncontrolled observational study

Study design: In cirrhotic patients undergoing extrahepatic surgery, within one month, a complete baseline evaluation is provided. Baseline evaluation (T0) includes: signature of informed consent, clinical history of liver disease, comorbidities and risk factors for hepato-biliary complications; complete laboratory tests; liver and spleen elastography (with Transient Elastography, ARFI or 2D-SWE).

After surgery, each patient is evaluated at T1 (+90 days) with Elastography, laboratory tests, clinical examination and T2 (+ 365 days) by a clinical examination.

Each center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner.

Study duration: The study period will last approx. 730 days, with a planned follow-up of 365 days after surgical intervention

Conditions

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Advanced Chronic Liver Disease Surgery--Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 yrs;
* Advanced chronic liver disease (LSM\>10 kPa)
* Any etiology (viral, metabolic, alcoholic, cholestatic and autoimmune);
* Elective extrahepatic surgery planned within three months and requiring regional or general anaesthesia;
* Patients are willing and able to give informed consent

Exclusion Criteria

* Presence of hepatic decompensation at the time of informed consent or previous events of hepatic decompensation during the last three months before enrollment.
* Presence of portal vein thrombosis
* Previous placement of TIPS,
* Prior liver transplantation,
* Surgical resection or shunt.
* Presence of active HCC that needed treatment at the time of informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Antonio Colecchia

Chair Gastroenterology Unit A, Borgo Trento

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANTONIO COLECCHIA, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Integrata Verona

DAVIDE FESTI, MD

Role: STUDY_CHAIR

University of Bologna

GIOVANNI MARASCO, MD; PhD

Role: STUDY_CHAIR

University of Bologna

CATERINA CUSUMANO, MD

Role: STUDY_CHAIR

Azienda Ospedaliera Universitaria Integrata Verona

KAMELA GJINI

Role: STUDY_CHAIR

Azienda Ospedaliera Universitaria Integrata Verona

FEDERICO RAVAIOLI, MD

Role: STUDY_CHAIR

University of Bologna

ELTON DAJTI, MD

Role: STUDY_CHAIR

University of Bologna

Locations

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