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Carcinoma, Hepatocellular

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Liver Diseases

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Chlorotrianisene

Cytoreductive Surgery followed by TACE for MNHCC

Cytoreductive Surgery

TACE alone or TACE followed by downstage resection for MNHCC

TACE

Weiping Zhou, M.D.

The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed by Transarterial Chemoembolization (TACE) with TACE alone in patients with MNHCC so as to establish a treatment standard for MNHCC.

Hepatocellular carcinoma (HCC) is one of the world's most common malignancies, especially in East-Asian countries. Hepatic resection has been accepted as the only means of cure for patients with HCC. The results of hepatic resection for early-stage HCC are favorable.Nevertheless, the role of surgical resection for multinodular HCC (MNHCC) is less well-defined.The presence of multiple tumors has been shown to be one of the most significant independent factors to influence cumulative survival rates in HCC after hepatic resection.Using the BCLC criteria,liver transplantation provides an alternative curative treatment option for MNHCC with size ≤ 5 cm in diameter and tumor number \<3，but MNHCC beyond these criteria usually receive palliative therapy.

For MNHCC which not suitable for curative treatment, non-surgical and surgical interventions are available for palliative care.Cytoreductive surgery has the potential to increase the quality and quantity of survival in patients with advanced HCC. Cytoreductive surgery is carried out with partial hepatectomy,cryosurgery,microwave coagulation therapy(MCT),or absolute alcohol injection.It has been shown to prolong survival and provide good symptomatic relief in patients with good surgical risks in non-randomized studies.Cytoreductive surgery aims at removal or destruction of all macroscopic tumours, allowing microscopic foci to persist while preserving as much of the functional liver tissue as possible. The development of effective local ablative therapy (LAT), such as radiofrequency ablation (RFA) therapy, facilitates reduction of the tumour burden even further during the operation.Cytoreductive surgery can also be followed by other non-surgical treatments,such as regional therapy or systemic therapy, to deal with the residual disease or micrometastases.

The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed by TACE with TACE alone in patients with MNHCC so as to establish a treatment standard for MNHCC.

Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma

A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC)

Eastern Hepatobiliary Surgery Hospital

vice president of the Eastern Hepatobiliary Surgery Hospital

Symptoms and General Pathology

Postoperative Complications

Pain, Postoperative

Pain

Central Nervous System Depressants

Analgesics

Anesthetics

Ropivacaine

Morphine

Anesthetics, Local

Analgesics, Opioid

Analgesics, Non-Narcotic

Ropivacaine is instillated through one multi-hole catheter wich would be inserted percutaneously in all patients and tunnelled about 1-2 cm lateral to the abdominal incision and the tip of the catheter placed in the intra-peritoneal cavity. The catheter would not be ligated and fixed in situ intra-peritoneally. Twenty ml of Ropivacaine would be injected subcutaneously along both sides of the incision prior to skin closure. Additionally, 20 ml of Ropivacaine (1mg/mL) would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen.

Saline is instillated through one multi-hole catheter wich would be inserted percutaneously in all patients and tunnelled about 1-2 cm lateral to the abdominal incision and the tip of the catheter placed in the intra-peritoneal cavity. The catheter would not be ligated and fixed in situ intra-peritoneally. Twenty ml of Saline would be injected subcutaneously along both sides of the incision prior to skin closure. Additionally, 20 ml of Saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen.

Saline

Sven-Egron Thorn, MD PhD

Anil Gupta, MD PhD

Sven-Erik Ricksten, MD PhD

Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.

The aim of this study is to measure the efficacy of local anesthetics (LA) administered into the intra-peritoneal cavity compared to placebo. Our hypothesis is that the injection of local LAs intra-peritoneally would reduce post-operative pain and the inflammatory process caused by the massive release of cytokines during extensive cytoreductive surgery. The study is a controlled, parallel group, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden . Twenty mL of ropivacaine or saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen according to group randomization in order to double blind patients and all personnel involved in the study.

The parameters that would be evaluated are inflammatory markers, postoperative morbidity, pain intensity, consumption of morphine, cognitive function and progression-free survival.

Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study

Analysis of the following inflammatory markers with Multiplex: IL(interleukin)-1β, IL-1rα, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, zBasic FGF (Fibroblast Growth Factor), Eotaxin, G-CSF (granulocyte colony stimulating factor), GM-CSF granulocyte macrophage colony stimulating factor), IFN-γ (interferon), IP-10 (immune protein), MCP-1 (monocyte chemotactic protein), MCAF (monocyte chemotactic and activating factor), MIP-1α (macrophage inflammatory protein), MIP-1β, PDGF-BB (platelet-derived growth factor), RANTES (regulated on activation, normal T cell expressed and secreted), TNF-α (tumor necrosis factor), VEGF (vascular endothelial growth factor)

Total amount of Morphine consumed during the first 48 hours after surgery

Pain Intensity is measured with Numeric Rating Score 0-10

Patients will complete the following neurophysiological tests upon entering the study and within one month after surgery: Verbal Learning Test (VLT), Concept Shifting Test (CST), Letter-Digit Coding, Verbal Learning Test - Delayed Recall (VLT-D)

Progression-free Survival measures the length of time after treatment during which the cancer being treated does not get worse.

Measuring the numbers of Postoperative Morbidity/Complications within one month after surgery:

Morbidity:

* Local infections
* Urinary infection (urine culture)
* Pneumonia (X-ray, C-reactive protein, Fever)
* Sepsis (Fever, Leucocyte count in blood, Heart Rate, Respiratory Rate)
* Pleural fluid (X-ray verified)
* Deep Vein Thrombosis (D-dimer, ultrasound verified)
* Pulmonary embolism (Computed Tomography/ Scint-X)
* Acute Myocardial Infarction (Electrocardiography, Troponin I)
* Atrial fibrillation or serious arrhythmia during the first 48 hours after surgery (Electrocardiography)
* Respiratory failure (prolonged mechanical ventilation)
* Renal failure (Serum Creatinine, Diuresis, AKIN criteria)
* Inotropic needs \> 12 hours after surgery

Surgical Complications:

* Intraabdominal bleeding
* Leakage from anastomosis
* Abdominal abscess
* Paralytic ileus
* Pancreatic leakage (requiring drainage)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma	NCT00820157	Hepatocellular ...	Cytoreductive S... TACE	18 Years - 70 Years	Eastern Hepatobiliary Surgery Hospital
Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery	NCT02256228	Pain	Ropivacaine Saline	18 Years - 74 Years	Göteborg University
Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma	NCT00820157	Hepatocellular ...	Cytoreductive S... TACE	18 Years - 70 Years	Eastern Hepatobiliary Surgery Hospital

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