Neoplasms

All Conditions

Hemangioma

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Pharmaceutical Solutions

Bleomycin

Liver Extracts

Ethiodized Oil

Sclerosing Solutions

Patients with symptomatic liver hemangioma undergoing sclerotherapy (percutaneous injection) with 45 units of Bleomycin once during the procedure

The liver mass will be punctured under guidance of ultrasonography with a 20- or 22-gauge Chiba needle. Contrast medium will be injected under fluoroscopy guidance to assess any possible communication with the biliary tree and to evaluate the amount of sclerosing agent which could be safely injected. Then, the mixture of Bleomycin (Bleocin-S; Korea United Pharm Inc., South Korea) and Lipiodol (Ultra-Fluid, Guerbet, France) will be slowly injected under continuous guidance of fluoroscopy. No more than 45 units of Bleomycin and 15 cc of Lipiodol will be injected in a single session.

sclerotherapy arm

Hadi Rokni Yazdi, MD

Percutaneous sclerotherapy is currently a widely used treatment for subcutaneous low-flow vascular malformations. Considered as a low-flow vascular malformation, symptomatic liver hemangiomas could also theoretically be safely and effectively treated by percutaneous sclerotherapy with a mixture of Bleomycin and Lipiodol. The safety and efficacy of percutaneous sclerotherapy was firstly introduced by the investigator's investigators in 5 patients in a pilot study. The aim of this study is to design and conduct a study to evaluate the safety and efficacy of percutaneous sclerotherapy in a larger sample size with a long term follow-up.

Twenty-five patients with symptomatic liver hemangioma will be enrolled after an informed consent being obtained. Patients' symptoms related to liver mass, including the pain severity being measured by visual analogue scale, discomfort, early satiety, or nausea will be recorded. Liver function tests, coagulation tests, and complete blood count will be checked before the intervention. A triple phase abdominal CT scan with the administration of intravenous contrast medium will also be performed before the procedure. Exclusion criteria include hepatic or renal impairment, abdominal symptoms unrelated to a liver mass, uncorrectable coagulopathy, lung fibrosis, allergy to contrast media, systemic infection, liver abscess, and biliary obstruction.

Patients will be sufficiently hydrated with normal saline before the procedure. Corticosteroid and prophylactic antibiotics will be administered before the procedure. Antibiotics will be continued for 3 days after the procedure.

The liver mass will be punctured under guidance of ultrasonography with a 20- or 22-gauge Chiba needle. Contrast medium will be injected under fluoroscopy guidance to assess any possible communication with the biliary tree and to evaluate the amount of sclerosing agent which could be safely injected. Then, the mixture of Bleomycin (Bleocin-S; Korea United Pharm Inc., South Korea) and Lipiodol (Ultra-Fluid, Guerbet, France) will be slowly injected under continuous guidance of fluoroscopy. No more than 45 units of Bleomycin and 15 cc of Lipiodol will be injected in a single session.

Any complication taking place during and within 30 days after the procedure will be recorded. Liver function tests, coagulation tests, and complete blood count will be repeated the day after the procedure, and 6 months after the procedure. Also, a triple phase abdominal CT scan will be repeated in 6 months, and 12 months after the intervention. The patients' symptoms will be asked by phone after 12 months. The changes in lesion size on CT scan and in patients' symptoms will be evaluated.

Clinical trials with a single arm investigating the safety and efficacy of percutaneous sclerotherapy of hepatic hemangiomas with the mixture of Bleomycin and Lipiodol

Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin

Pain is subjectively assessed based on a visual analog scale (VAS) before and 6 months after intervention. Change in VAS is recorded.

VAS is between zero (no pain at all) and 10 (worst pain imaginable).

Incidence of major adverse events that may cause any of the following: A) Require therapy, minor hospitalization (less than 48 hours) B) Require major therapy, unplanned increase in level of care, prolonged hospitalization (more than 48 hours) C) Permanent adverse sequel D) Death

The size of the hemangioma is assessed on CT scans performed before and 6 months after the procedure. The largest diameter of the hemangioma is measured on axial images.

Tehran University of Medical Sciences

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Cholangiocarcinoma

Liver Neoplasms

Hyperplasia

Focal Nodular Hyperplasia

Bile Duct Cancer

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

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Propranolol hydrochloride tablets were taken orally three times a day at an initial dose of 30 mg/day, doubled one week later until the daily dose was 1.5 mg/kg. If the dose was unable to increase due to side effects, the maximum dose tolerable was maintained for 6 months.

Oral propranolol hydrochloride tablets are administration for 6 months at dose of 1.5 mg/kg or the maximum dose tolerable.

Propranolol Hydrochloride

Tingbo Liang, MD PhD

Qi Zhang, MD

Hepatic hemangioma is one of the most common benign tumor of the liver. Although the overall prognosis is good, active interventions are still needed in high-risk patients. Without specific drugs, the main treatment methods include surgical treatments, interventional therapies and radiotherapies. Effective medical treatments are needed urgently. Propranolol has achieved good results in infantile Facial/hepatic hemangioma, and shows some effectiveness in adult hemangioma. Here, investigators intend to evaluate the therapeutic effect of propranolol in adult hepatic hemangioma.

In view of the lack of medical treatment for hepatic hemangioma, investigators chose hemangioma patients with a diameter of 5-10 cm and no significant risk of rupture, or those with surgical indications but rejected of surgical, interventional/radiological interventions. After confirmation of no high risk for drugs, oral propranolol was given. The tumor size, objective remission rate, disease control rate, drugs related side effects and other endpoints events were recorded and analyzed, to assess the propranolol could or couldn't effectively control the progress of hepatic hemangioma.

Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma

Percentage of patients whose cancer doesn't progress after treatment

Level of serum Vascular endothelial growth factor

According to Common Toxicity Criteria for Adverse Effects version 4

Evaluating maximum diameter obtained by contrast-enhanced CT scanning

Percentage of patients whose cancer shrinks or disappears after treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin	NCT03649113	Hemangioma Live...	sclerotherapy a...	18 Years - 80 Years	Tehran University of Medical Sciences
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
Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma	NCT03633747	Hemangioma Live...	Propranolol Hyd...	18 Years - 65 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin	NCT03649113	Hemangioma Live...	sclerotherapy a...	18 Years - 80 Years	Tehran University of Medical Sciences

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