Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Ischemia

Liver Neoplasms

Hemangioma

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Sham remote ischemic conditioning (Sham-RIC) is applied in the perioperative using an automated Sham-RIC device.

Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device once daily.

Remote ischemic conditioning (RIC) is applied in the perioperative using an automated RIC device twice daily.

Sham-Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.

Sham-Remote Ischemic Conditioning

Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, the morning of the postoperative day 1, the morning of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg.

Sham-Remote Ischemic Conditioning (at the time points of 30 min after surgery, the afternoon of the postoperative day 1, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff, but the cuff pressure will be 0 mmHg.

Remote Ischemic Conditioning Once Daily

Remote Ischemic Conditioning (at the time points of 30 min before anesthesia, 30 min after surgery, the morning of the postoperative day 1, the afternoon of the postoperative day 1, the morning of the postoperative day 2, the afternoon of the postoperative day 2): Three cycles (30 minutes), each consisting of five minutes of cuff inflation followed by five minutes with a deflated cuff. The cuff pressure will be 200 mmHg.

Remote Ischemic Conditioning Twice Daily

He Huang, ph.D

Chun Tian, ph.D

Our primary aim is to investigate whether perioperative remote ischemic conditioning (PRIC) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.

Remote Ischemic Conditioning (RIC) can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. This protection can be applied prior to or during a prolonged ischemic event as remote ischemic pre-conditioning (RIPreC) and per-conditioning (RIPerC), respectively, or immediate after reperfusion as remote ischemic post-conditioning (RIPostC).

RIC is a non-pharmacologic and non-invasive treatment without noticeable discomfort, commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion. However, whether perioperative remote ischemic conditioning (PRIC) can improve postoperative recovery in patients undergoing hepatectomy has never been investigated in a randomized controlled trial.

Prospective, randomized, patient-assessor blinded, sham-controlled trial

Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

The individual participant data for this study is available from the sponsor on reasonable request through email.

The levels of ALT in perioperative period

The levels of AST in perioperative period

The levels of TBIL in perioperative period

The levels of INR in perioperative period

The levels of ALB in perioperative period

The levels of TNF-α in perioperative period

The levels of MDA in perioperative period

The levels of HO-1 in perioperative period

The levels of NF-κB in perioperative period

The levels of HMGB1 in perioperative period

The levels of platelet in perioperative period

The levels of WBC in perioperative period

The levels of neutrophil granulocyte percentage in perioperative period

Gastrointestinal tolerance was defined as transanal or stoma defecation and oral dietary tolerance.

Prolonged postoperative ileus was diagnosed if patients met two or more of the following conditions on or after postoperative day 4: inability to tolerate the oral diet over the past 24 h, nausea or vomiting, without flatus over the past 24 h, abdominal distension or radiological evidence of intestinal distension without mechanical intestinal obstruction.

The postoperative complications were recorded using the Clavien-Dindo classification system and included: nausea or vomiting, abdominal distension, anastomotic leakage, new pulmonary infection, poor wound healing, cognitive dysfunction, unplanned reoperation, and 30-day readmission rate.

The Second Affiliated Hospital of Chongqing Medical University

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

Second Affiliated Hospital, School of Medicine, Zhejiang University

Conventional radiofrequency ablation procedures

After destroying the main blood supply of the tumor, extracting the blood in the tumor, reducing the blood flow in the tumor and shrinking the tumor volume, the remaining tumor was then treated with radiofrequency ablation, namely the "three-step" radiofrequency ablation with "one block, two inhalation and three damages".

"three-step" radiofrequency ablation

radiofrequency ablation

Hepatic hemangioma is the most common benign tumor of the liver.For huge liver hemangioma, however, it need to use the conventional radiofrequency ablation can increase one-time ablation volume of radiofrequency electrode or enhance ablation power and extend the melting time, not only bring patients suffering discomfort, but easy to damage the adjacent organs, causing serious complications such as hemorrhage, perforation of gastrointestinal tract,acute renal failure .Therefore, the investigators have developed a new, standardized radiofrequency ablation for giant hepatic hemangioma to shorten the duration of treatment, reduce surgical complications and improve the surgical success rate.

The purpose of this study was to evaluate the safety, feasibility and efficacy of the new radiofrequency ablation (" three-step "radiofrequency ablation) in the treatment of giant hepatic hemangioma.

Hepatic hemangioma is the most common benign tumor of the liver, with an incidence of 0.4-20% in the general population.For small and asymptomatic patients with hepatic hemangioma, regular reexamination is necessary without medical intervention.However, patients with giant hepatic hemangioma(diameter ≥ 5cm) may have symptoms such as abdominal pain, indigestion, jaundice, or rapid increase in lesion volume, or even spontaneous rupture and hemorrhage, which require active treatment.Currently, surgical resection is the most effective method for the treatment of hepatic hemangioma, but the incidence and mortality of related complications have been reported as high as 27% and 3% respectively

.Other alternative therapies, such as transcatheter arterial embolization, radiotherapy and steroid therapy, have also been reported for the treatment of hepatic hemangioma, but the efficacy is not satisfactory .

Percutaneous ultrasound-guided radiofrequency ablation is a safe and minimally invasive treatment with reliable efficacy. In recent years, this technique has been successfully applied in the treatment of hepatic hemangioma with a diameter of \< 5cm.For huge liver hemangioma, however, need to use the conventional radiofrequency ablation can increase one-time ablation volume of radiofrequency electrode or enhance ablation power and extend the melting time, not only bring patients suffering discomfort, but easy to damage the adjacent organs, causing serious complications such as hemorrhage, perforation of gastrointestinal tract, acute renal failure .Therefore, the investigators have developed a new,standardized radiofrequency ablation for giant hepatic hemangioma to shorten the duration of treatment, reduce surgical complications and improve the surgical success rate.

The purpose of this study was to evaluate the safety, feasibility and efficacy of the new radiofrequency ablation (" three-step "radiofrequency ablation) in the treatment of giant hepatic hemangioma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy	NCT06130436	Hepatic Hemangi... Liver Cancer Hepatolithiasis Hepatectomy	Sham-Remote Isc... Remote Ischemic... Remote Ischemic...	25 Years - 75 Years	The Second Affiliated Hospital of Chongqing Medical University
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
Percutaneous Ultrasound-guided "Three-step" Radiofrequency Ablation for Giant Hepatic Hemangioma	NCT04131153	Hepatic Hemangi...	"three-step" ra... radiofrequency ...	18 Years - 70 Years	Southwest Hospital, China
Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy	NCT06130436	Hepatic Hemangi... Liver Cancer Hepatolithiasis Hepatectomy	Sham-Remote Isc... Remote Ischemic... Remote Ischemic...	25 Years - 75 Years	The Second Affiliated Hospital of Chongqing Medical University

Spots Global Cancer Trial Database for hepatic hemangioma