Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis

NCT01992978 | Unknown DMC

• 1 other identifier: SWHB2013-005
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.

Conditions

Hepatocellular Carcinoma; Cirrhosis

Keywords

radiofrequency-assisted（RF）; hepatectomy; postoperative liver injury

Outcome Measures

Primary Outcomes (1)

• Postoperative liver injury

  The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days.

  postoperative 90 days

Secondary Outcomes (2)

• Number of Participants with Adverse Events

  postoperative 90 days

• Overall survival

  1,3,5-year overall survival

Other Outcomes (1)

• Blood parameter change after operation

  discharge from hospital (2 weeks)

Study Arms (2)

radiofrequency-assisted resection group（RF-R)

EXPERIMENTAL

Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.

Procedure: Radiofrequency-assisted Hepatectomy

conventional liver resection group（CLR-R）

ACTIVE COMPARATOR

Conventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical.

Procedure: Conventional Hepatectomy

Interventions

Radiofrequency-assisted Hepatectomy PROCEDURE

Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.

radiofrequency-assisted resection group（RF-R)

Conventional Hepatectomy PROCEDURE

Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.

conventional liver resection group（CLR-R）

Eligibility Criteria

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

You may qualify if:

• Aged from 18 to 65 years , no gender restriction.
• Clinical diagnosis of resectable HCC.
• Preoperative liver function test showed Child-Pugh Class A or B.
• Indocyanine green retention at 15 minutes (ICG-15) of \<30%.
• Acceptable clotting profile :platelet count \> 50 x 109/L and a prolonged prothrombin time of \< 5 seconds.
• Enough relative residual liver volume (%RLV) ≥ 40%.
• No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
• No other anti-tumor therapy received before the treatment.
• No metastasis in lymphnode or other organs.
• Written consent inform assigned.

You may not qualify if:

• Pregnancy.
• Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis.
• Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Institute of Hepatobiliry surgery,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaowu Li, MD-Ph D

  Institute of hepatobiliry surgery,Southwest hospital

  STUDY DIRECTOR

Central Study Contacts

Rui Guo, Master of Medicine

CONTACT

86-23-15922654727; ruixx032@163.com

Li Liu, MD

CONTACT

86-23-68754374; guor2006@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Xiaowu Li

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

CN (1)