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Status unknownNCT04615091Updated Nov 4, 2020

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

An observational study in Advanced Chronic Liver Disease and Surgery--Complications, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Status unknown at 37 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-04.

Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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

02

Conditions studied

  • Advanced Chronic Liver Disease
  • Surgery--Complications

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Keywords

  • liver stiffness
  • spleen stiffness
  • portal hypertension
  • liver cirrhosis
  • extrahepatic surgery
  • transient elastography
  • fibroscan
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 250 is above the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 92 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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)

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Early post-surgical (at +90 days) complications after extrahepatic surgery

    Complications related to the surgical procedure and/or liver disease after the extrahepatic elective surgery

    Time frame: 90 days after surgery

Secondary outcomes

  1. The liver-related events and overall survival at +90 days and + 360 days after extrahepatic 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

    Time frame: 360 days after surgery

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Study locations

1 of 37 sites recruiting
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References and documents

Publications

  • Uyei J, Taddei TH, Kaplan DE, Chapko M, Stevens ER, Braithwaite RS. Setting ambitious targets for surveillance and treatment rates among patients with hepatitis C related cirrhosis impacts the cost-effectiveness of hepatocellular cancer surveillance and substantially increases life expectancy: A modeling study. PLoS One. 2019 Aug 26;14(8):e0221614. doi: 10.1371/journal.pone.0221614. eCollection 2019. PubMed 31449554 ↗
  • Newman KL, Johnson KM, Cornia PB, Wu P, Itani K, Ioannou GN. Perioperative Evaluation and Management of Patients With Cirrhosis: Risk Assessment, Surgical Outcomes, and Future Directions. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2398-2414.e3. doi: 10.1016/j.cgh.2019.07.051. Epub 2019 Jul 31. PubMed 31376494 ↗
  • Reverter E, Cirera I, Albillos A, Debernardi-Venon W, Abraldes JG, Llop E, Flores A, Martinez-Palli G, Blasi A, Martinez J, Turon F, Garcia-Valdecasas JC, Berzigotti A, de Lacy AM, Fuster J, Hernandez-Gea V, Bosch J, Garcia-Pagan JC. The prognostic role of hepatic venous pressure gradient in cirrhotic patients undergoing elective extrahepatic surgery. J Hepatol. 2019 Nov;71(5):942-950. doi: 10.1016/j.jhep.2019.07.007. Epub 2019 Jul 19. PubMed 31330170 ↗
  • Colecchia A, Ravaioli F, Marasco G, Colli A, Dajti E, Di Biase AR, Bacchi Reggiani ML, Berzigotti A, Pinzani M, Festi D. A combined model based on spleen stiffness measurement and Baveno VI criteria to rule out high-risk varices in advanced chronic liver disease. J Hepatol. 2018 Aug;69(2):308-317. doi: 10.1016/j.jhep.2018.04.023. Epub 2018 May 3. PubMed 29729368 ↗
  • Colecchia A, Montrone L, Scaioli E, Bacchi-Reggiani ML, Colli A, Casazza G, Schiumerini R, Turco L, Di Biase AR, Mazzella G, Marzi L, Arena U, Pinzani M, Festi D. Measurement of spleen stiffness to evaluate portal hypertension and the presence of esophageal varices in patients with HCV-related cirrhosis. Gastroenterology. 2012 Sep;143(3):646-654. doi: 10.1053/j.gastro.2012.05.035. Epub 2012 May 27. PubMed 22643348 ↗
  • Ma X, Wang L, Wu H, Feng Y, Han X, Bu H, Zhu Q. Spleen Stiffness Is Superior to Liver Stiffness for Predicting Esophageal Varices in Chronic Liver Disease: A Meta-Analysis. PLoS One. 2016 Nov 9;11(11):e0165786. doi: 10.1371/journal.pone.0165786. eCollection 2016. PubMed 27829057 ↗
  • Cescon M, Colecchia A, Cucchetti A, Peri E, Montrone L, Ercolani G, Festi D, Pinna AD. Value of transient elastography measured with FibroScan in predicting the outcome of hepatic resection for hepatocellular carcinoma. Ann Surg. 2012 Nov;256(5):706-12; discussion 712-3. doi: 10.1097/SLA.0b013e3182724ce8. PubMed 23095613 ↗
  • Marasco G, Colecchia A, Dajti E, Ravaioli F, Cucchetti A, Cescon M, Festi D. Prediction of posthepatectomy liver failure: Role of SSM and LSPS. J Surg Oncol. 2019 Mar;119(3):400-401. doi: 10.1002/jso.25345. Epub 2018 Dec 18. No abstract available. PubMed 30561034 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04615091
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Responsible party
Antonio Colecchia (Chair Gastroenterology Unit A, Borgo Trento, Azienda Ospedaliera Universitaria Integrata Verona) — Principal investigator
First posted
Nov 4, 2020
Start date
Aug 30, 2020
Primary completion
Oct 2021 (estimated)
Completion
Aug 2022 (estimated)
Last update
Nov 4, 2020

Study contacts

FEDERICO RAVAIOLI, MD; PhD
Contact
f.ravaioli@unibo.it
+393333176759
ELTON DAJTI, MD
Contact
elton.dajti2@unibo.it
ANTONIO COLECCHIA, MD
principal investigator · Azienda Ospedaliera Universitaria Integrata Verona
DAVIDE FESTI, MD
study chair · University of Bologna
GIOVANNI MARASCO, MD; PhD
study chair · University of Bologna
CATERINA CUSUMANO, MD
study chair · Azienda Ospedaliera Universitaria Integrata Verona
KAMELA GJINI
study chair · Azienda Ospedaliera Universitaria Integrata Verona
FEDERICO RAVAIOLI, MD
study chair · University of Bologna
ELTON DAJTI, MD
study chair · University of Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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