Clinical Trials Logo
  1. Home
  2. Surgery--Complications
  3. NCT04615091

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

Surgery--Complications Clinical Trial

Official title:
"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."

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04615091
Study type Observational
Source Azienda Ospedaliera Universitaria Integrata Verona
Contact FEDERICO RAVAIOLI, MD; PhD
Phone +393333176759
Email f.ravaioli@unibo.it
Status Recruiting
Phase
Start date August 30, 2020
Completion date August 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT03930784 - A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery.
Not yet recruiting NCT04430972 - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Recruiting NCT04887415 - Respiratory Strength Training in Cardiac Surgical Patients N/A
Recruiting NCT05254262 - Multicenter National Trial of Clinical Results of Surgical Elderly Patients
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Recruiting NCT05155878 - Prognostic Factors in Periampullary Tumors and Cysts
Recruiting NCT04967391 - Tumescence in HNC Skin Graft Reconstruction Phase 3
Terminated NCT03757455 - ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy N/A
Completed NCT03793816 - Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial N/A
Completed NCT03246165 - Predictive Factors and Complications of Delirium
Withdrawn NCT04090918 - Novel Methods for Characterizing Patients With Post-operative Atrial Fibrillation Secondary to Abdominal Surgery
Completed NCT05373238 - Same Day Discharge After Laparoscopic Hysterectomy
Completed NCT03938584 - The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients N/A
Not yet recruiting NCT05046925 - PACU for Postoperative Care After Major Thoracic and Abdominal Surgery
Not yet recruiting NCT04199208 - Does Prehabilitation Improve Outcome in Coloncancer Surgery? N/A
Completed NCT04550156 - Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections N/A
Completed NCT04257344 - Use of Wearables for Early Detection of Complications After Major Acute Abdominal Surgery
Active, not recruiting NCT03721471 - Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty