A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC

NCT03313648 | Unknown DMC

• 1 other identifier: SWHZSG007
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

To observe and compare the short-term and long-term oncological outcome of laparoscopic hepatectomy and radiofrequency ablation in the treatment of recurrent hepatocellular carcinoma .

Conditions

Hepatocellular Carcinoma Recurrent

Keywords

Recurrent HCC; Laparoscopic Hepatectomy; RFA; RCT

Outcome Measures

Primary Outcomes (1)

• Survival rate

  follow-up after the surgery every 3 months, to understand statistics 5-year survival.

  5 years

Secondary Outcomes (1)

• intraoperative parameters

  during the operation

Other Outcomes (1)

• postoperative complications

  Duration hospitalization(an expected average of 7 days)

Study Arms (2)

Laparoscopic Hepatectomy

EXPERIMENTAL

Improvements in laparoscopic technology mean that LH now has superior short-term efficacy and similar long-term efficacy to open surgery , and LH has shown significant advantages in applications involving recurrent HCC.

Procedure: Laparoscopic Hepatectomy

Radiofrequency Ablation

ACTIVE COMPARATOR

With recent technological advances, RFA has become the most widely investigated new first-line therapeutic option for recurrent HCCs . Numerous large studies have demonstrated the advantages of RFA, which include its ease of use, safety, effectiveness, minimal invasiveness, and minimal morbidity and mortality .

Procedure: Radiofrequency Ablation

Interventions

Laparoscopic Hepatectomy PROCEDURE

180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.

Laparoscopic Hepatectomy

Radiofrequency Ablation PROCEDURE

180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.

Radiofrequency Ablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender,18 to 70 years old;
• Preoperative diagnosis of recurrent HCC clear,liver resection was done previously;
• No active hepatitis and decompensated cirrhosis;
• Patient with previous liver resection, maximum diameter ≤5cm single recurrent nodules or 3 nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn;
• No tumor rupture or bleeding;
• Child-Pugh class A or B grade,ICG-R15 \<20%;
• No coagulation disorders,platelet count \> 50 × 109 / L and prolonged prothrombin time \< 5 seconds;
• After diagnosis of recurrent HCC,not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery;
• Recurrent nodules are not close to intestines,stomach,cholecyst or diaphragm muscle, not close to the first porta hepatis,main vessel and biliary ducts;
• Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications;
• Voluntarily participate in the study, voluntarily accept any therapy of two,informed consent.

You may not qualify if:

• Severe upper abdominal adhesions;
• Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin;
• Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up;
• Nodules proved to be not recurrent HCC during intraoperative exploration, such as:liver metastases of colorectal cancer.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Shuguo Zheng

  Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

  STUDY DIRECTOR

Central Study Contacts

Shuguo Zheng

CONTACT

0086-13508308676; shuguozh@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University

Model Details: Two different treatments are conducted on the participant base on the randomized choices

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 18, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

CN (1)