Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Cholangiocarcinoma

Liver Cirrhosis

Carcinoma, Hepatocellular

Liver Diseases

Liver Neoplasms

Fibrosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Bile Duct Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients with any of the following conditions:

liver cirrhosis of any origin chronic hepatitis B infection chronic hepatitis C infection with advanced fibrosis non-alcoholic steatohepatitis (NASH) hemochromatosis

Interventions: B-mode ultrasound, contrast enhanced ultrasound (CEUS); MRI / histology

CEUS with SonoVue following standardized protocol

contrast enhanced ultrasound (CEUS)

Histology

Barbara Schellhaas, MD

Deike Strobel, MD

Aim of this prospective national multicenter study is to improve standardization of contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients.

The study is funded by the German Society for Ultrasound in Medicine (DEGUM).

To date, CEUS criteria for non-invasive diagnosis of HCC include arterial phase hyperenhancement, followed by contrast washout in the portal venous or late phase. We would like to investigate the following points:

1. whether arterial hyperenhancement alone is sufficient for the definite diagnosis of HCC in cirrhosis with CEUS
2. whether a further clearly-defined point of assessment in the late phase after 4-6 minutes is of additional diagnostic value in focal liver lesions showing no contrast washout after 3 minutes
3. diagnostic value of CEUS-based standardised diagnostic algorithms (ESCULAP = Erlanger Synopsis of Contrast Enhanced Ultrasound for Liver lesion Assessment in Patients at risk; CEUS LI-RADS = Contrast Enhanced Ultrasound Liver Imaging Reporting and Data System) for non-invasive diagnosis of HCC in high-risk patients (diagnostic accuracy, interobserver-variability, feasability in clinical Routine).

Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study

Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a Prospective German Multicenter Study

Diagnostic accuracy, interobserver-variabilty and feasability in clinical routine for CEUS-based algorithms Reference Standard: histology / MRI

Sensitvity, specificity, positive and negative predictive value of arterial hyperenhancement only compared with arterial hyperenhancement followed by contrast washout for non-invasive diagnosis of HCC in high-risk patients Reference Standard: histology / MRI

Diagnostic value of an additional standardised examination point in the late phase after 4-6 minutes in lesions without contrast washout after 3 minutes Reference Standard: histology / MRI

Sensitvity, specificity, positive and negative predictive value of contrast-enhanced ultrasound for non-invasive diagnosis of ICC in high-risk patients / differential diagnosis of HCC versus ICC Reference Standard: histology

ESCULAP versus CEUS LI-RADS (diagnostic accuracy, interobserver agreement) Reference Standard: histology / MRI

Comparison of CEUS and MRI for non-invasive diagnosis of HCC (diagnostic accuracy, interobserver agreement) Reference Standard: histology

correlation of histological grading and contrast enhancement pattern

University Hospital Erlangen

Neoplasm Metastasis

Hyperplasia

Hemangioma

Focal Nodular Hyperplasia

Nodular Regenerative Hyperplasia

liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).

liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)

liver transection during laparoscopic liver resection

Mikhail Efanov, MD, PhD

Background: until now, there is no agreement about the safest and feasible method for liver parenchyma transection during laparoscopic liver resection.

Study design: prospective, randomized, single-center The purpose of the study: comparison of short-term results of two methods of parenchyma liver transection during laparoscopic liver resection

two groups will be compared. Group 1: liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).

Group 2: liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)

Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection

Morbidity according to Clavien-Dindo classification (it is advisable to activate complications class II-V). The Clavien-Dindo classification (CDC) is a standardized system for the registration of surgical complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The major characteristic of the CDC system is that the severity of a complication is graded based on the type of therapy required to treat the complication. The CDC system has been validated and accepted worldwide for use in many fields of surgery. The complications that change the treatment of grade II-V.

Absolute blood loss (ml) will be calculated as the amount of blood (collected only during the parenchyma resection) in suction the container after the subtraction of all irrigating fluids and weighing operative sponges.

Аbsolute measurement of blood loss in relation to resection size (ml/cm\^2).

Duration of liver parenchyma transaction (min)

the number of participants who needed to apply the Pringle maneuver

The total duration of Pringle maneuver (min)

Moscow Clinical Scientific Center

Clinial Research

The definition of adverse event, used to collect adverse event information, no differs from the clinicaltrials.gov Definitions

liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).

liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection

ErbeJet

liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)

liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection

Misonix

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Body mass index (BMI)

ASA 1

ASA 2

ASA 3

ASA 1: A normal healthy patient. ASA 2: A patient with a mild systemic disease. ASA 3: A patient with a severe systemic disease that is not life-threatening. ASA 4: A patient with a severe systemic disease that is a constant threat to life. ASA 5: A moribund patient who is not expected to survive without the operation. The patient is not expected to survive beyond the next 24 hours without surgery. ASA 6: A brain-dead patient whose organs are being removed with the intention of transplanting them into another patient.

Physical status classification system (ASA)

Malignant

Bening

Malignant/benign lesions

Tumor size (mm)

Postero-superior segments

IWATE criteria proposed at the International Consensus Conference on Laparoscopic Liver Resection as difficulty scoring system for laparoscopic liver resection. Difficulty index includes the type of liver resection (partial resection, segmentectomy, and sectionectomy), the size and topography of the tumor, its proximity to the large vessels of the liver, the presence and stage of liver cirrhosis (CTP) and has a scale ranging from 0 to 12. Difficalty level: low 0-4, intermediate 4-6, advanced 7-9, expert 10-12.

Difficulty index score (IWATE Criteria) Low\Intermediate\Advanced\Expert

an addition to the exclusion criteria specified in the design of the study, the latter were expanded due to the following position. This made it difficult to recruit patients to the study.

Mikhail Efanov, MD, PhD,

Intraoperative Blood Loss

Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)

Duration of Liver Parenchyma Transaction

Necessity to Apply the Pringle Maneuver.

The Total Duration of Pringle Maneuver.

Hospital Stay (Day)

Morbidity

Overall Study

Antineoplastic Agents

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Drug eluting Beads (DC Beads) loaded with Doxorubicin

Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)

DEB TACE every 6 weeks until either no viable tumor or endpoint reached.

DEB TACE

Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.

SIRT

Roman Kloeckner, MD

Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study	NCT03405909	Hepatocellular ... Cholangiocarcin... Liver Cirrhosis Liver Cancer Liver Neoplasms Liver Diseases	contrast enhanc... MRI Histology	18 Years -	University Hospital Erlangen
Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection	NCT03208192	Liver Transecti...	liver transecti...	18 Years - 80 Years	Moscow Clinical Scientific Center
Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).	NCT01798147	Intrahepatic Ch...	DEB TACE SIRT	18 Years -	Johannes Gutenberg University Mainz
Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection	NCT03208192	Liver Transecti...	liver transecti...	18 Years - 80 Years	Moscow Clinical Scientific Center

Spots Global Cancer Trial Database for intrahepatic cholangiocellular carcinoma