Evaluating Ultrasound, Elastometry, Minilaparoscopy and Histology for the Diagnosis of Compensated Liver Cirrhosis.

NCT01807013 | Unknown

• 1 other identifier: LapSon
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective study to evaluate the dignostic value of b-mode ultrasound, elastometry and mini-laparoscopic guided liver biopsy for the diagnosis of compensated liver cirrhosis.

Conditions

Cirrhosis

Keywords

cirrhosis; liver; elastometry; ultrasound; laparoscopy; diagnosis

Outcome Measures

Primary Outcomes (1)

• Prospective Evaluation of Acoustic Radiation Force Impulse (ARFI) Elastography and High-Frequency B-Mode Ultrasound in Compensated Patients for the Diagnosis of Liver Fibrosis/Cirrhosis in Comparison to Mini-Laparoscopic Biopsy

  Histology is obtained at minilaparoscopy. For an Ishak fibrosis stage of 5/6 or a clearly nodular liver surface at minilaparoscopy cirrhosis is confirmed.

  blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours

Secondary Outcomes (1)

• Can the non invasive tests be combined resulting in a better accuracy for the prediction of liver cirrhosis/fibrosis?

  blood tests, b-mode ultrasound, ARFI and minilaparoscopy to be done preferential within 48 hours

Other Outcomes (1)

• What liver related complications develop and by which test are they best predicted?

  Follow up patients for 3/5 years

Interventions

ultrasound, liver elastometry, minilaparoscopy PROCEDURE

* conventional high-end ultrasound technique, * small access laparoscopy with fine laparoscopes * Acoustic radiation force impulse (ARFI): ARFI technology uses short-duration acoustic radiation forces (approximately 100 microseconds) to generate a localized tissue displacement which results in a lateral shear-wave propagation. ARFI shear wave velocity (SWV) measured in m/sec tracked with ultrasonic correlation-based methods is proportional to the square root of tissue elasticity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with suspected chronic liver disease

You may qualify if:

• clinical decision to perform minilaparoscopic guided liver biopsy for the staging of liver disease including the assessment of the degree of fibrosis.

You may not qualify if:

• ascites
• decompensated liver disease
• esophageal varices
• other collateral circulations
• obstructive cholestasis
• severe heart insufficiency (NYHA III-IV)

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

Universitätsklinikum Erlangen Nürnberg

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Fibrosis; Disease

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Deike Stobel, Prof. Dr.

  Universitätsklinikum Erlangen-Nürnberg

  STUDY DIRECTOR

Central Study Contacts

Deike Strobel, Prof. Dr.

CONTACT

09131 - 8535261; deike.strobel@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: March 8, 2013
• Study Start: February 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2016
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

DE (1)