Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC

NCT ID: NCT02563158

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-31

Brief Summary

The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.

Detailed Description

High prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Liver resection remains the mainstay of treatment for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. A major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. And the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. Given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. This study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion.

This study will include eligible patients with HBV-related HCC elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to five years. Data will be statistically analyzed on an intention-to-treat basis.

This prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for HBV-related HCC without vascular occlusion. Clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.

Conditions

Liver Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hx with hepatic inflow occlusion

Hepatectomy is carried out using Pringle maneuver in cycles of 15 minutes clamping + 5 minutes unclamping of the hepatoduodenal ligament.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hx with non-occlusion technique

Hepatectomy without hepatic inflow occlusion (non-occlusion technique)

Group Type: EXPERIMENTAL

non-occlusion technique

Intervention Type: PROCEDURE

Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)

Interventions

non-occlusion technique

Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)

Intervention Type: PROCEDURE

Other Intervention Names

hepatectomy without hepatic inflow occlusion

Eligibility Criteria

Inclusion Criteria

1. Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A;

2. Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy;

3. Tumors located either in the left or right hemiliver;

4. Resection extent was a hemi-hepatectomy or less;

5. Informed consent.

Exclusion Criteria

1. Having comorbidity that contraindicates surgery;

2. Participation in concurrent interventional trials with interference to this study;

3. Eligible for laparoscopic hepatectomy;

4. Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction;

5. Lack of compliance for treatment or future follow-up.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Prof. Shichun Lu

Director, Department of Hepatobiliary Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shichun Lu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shichun Lu, MD, PhD

Role: CONTACT

sclu_301@163.com

+86 10 68160801

Yinzhe Xu, MD, PhD

Role: CONTACT

james_hbp@163.com

+1 617 818 4081

Facility Contacts

Yinzhe Xu, M.D., Ph.D.

Role: primary

james_hbp@163.com

86-10-66936609

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Fu SY, Lau WY, Li GG, Tang QH, Li AJ, Pan ZY, Huang G, Yin L, Wu MC, Lai EC, Zhou WP. A prospective randomized controlled trial to compare Pringle maneuver, hemihepatic vascular inflow occlusion, and main portal vein inflow occlusion in partial hepatectomy. Am J Surg. 2011 Jan;201(1):62-9. doi: 10.1016/j.amjsurg.2009.09.029. Epub 2010 Apr 20.

Reference Type: RESULT

PMID: 20409520 (View on PubMed)

Xu Y, Chen J, Wang H, Zheng H, Feng D, Zhang A, Leng J, Duan W, Yang Z, Chen M, Shi X, Cai S, Ji W, Jiang K, Zhang W, Chen Y, Gu W, Dong J, Lu S. Perioperative and long-term outcomes of liver resection for hepatitis B virus-related hepatocellular carcinoma without versus with hepatic inflow occlusion: study protocol for a prospective randomized controlled trial. Trials. 2016 Oct 11;17(1):492. doi: 10.1186/s13063-016-1621-9.

Reference Type: DERIVED

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Other Identifiers

NO. 2012BAI06B01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NO. 2012ZX10002-017

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

JFJZYY-GD-15-01

Identifier Type: -

Identifier Source: org_study_id