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

November 3, 2020 updated by: Antonio Colecchia, Azienda Ospedaliera Universitaria Integrata Verona

"Prognostic Role of Portal Hypertension Assessed by Non-invasive Methods to Stratify Surgical Risk in Compensated Advanced Chronic Liver Disease Patients Undergoing Elective Extrahepatic Surgery: ELASTOSURGERY STUDY."

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced chronic liver disease patients who are planned an elective extrahepatic surgery (abdominal, orthopaedics and thoracic-cardiovascular surgeries)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early post-surgical (at +90 days) complications after extrahepatic surgery
Time Frame: 90 days after surgery
Complications related to the surgical procedure and/or liver disease after the extrahepatic elective surgery
90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The liver-related events and overall survival at +90 days and + 360 days after extrahepatic surgery
Time Frame: 360 days after surgery
Liver-related events (decompensation, TIPS placement, liver transplantation) or death (liver e non-liver related) at 90 days 360 days from the elective extra-hepatic surgery
360 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Investigators

  • Principal Investigator: ANTONIO COLECCHIA, MD, Azienda Ospedaliera Universitaria Integrata Verona
  • Study Chair: DAVIDE FESTI, MD, University of Bologna
  • Study Chair: GIOVANNI MARASCO, MD; PhD, University of Bologna
  • Study Chair: CATERINA CUSUMANO, MD, Azienda Ospedaliera Universitaria Integrata Verona
  • Study Chair: KAMELA GJINI, Azienda Ospedaliera Universitaria Integrata Verona
  • Study Chair: FEDERICO RAVAIOLI, MD, University of Bologna
  • Study Chair: ELTON DAJTI, MD, University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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