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

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ClinicalTrials.gov Identifier: NCT02563158
Recruitment Status : Unknown
Verified May 2016 by Prof. Shichun Lu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Shichun Lu, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Surgery Procedure: non-occlusion technique Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short- and Long-term Outcomes of Liver Resection With Versus Without Hepatic Inflow Occlusion for the Hepatitis B Virus-related Hepatocellular Carcinoma: a Prospective Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
No Intervention: 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.
Experimental: Hx with non-occlusion technique
Hepatectomy without hepatic inflow occlusion (non-occlusion technique)
Procedure: non-occlusion technique
Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)
Other Name: hepatectomy without hepatic inflow occlusion




Primary Outcome Measures :
  1. Serum total bilirubin on postoperative day 5 [ Time Frame: 5 days ]
    Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.


Secondary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: Entire operation duration ]
    Total blood loss from the incision to the closure of abdomen

  2. Requirement of blood transfusion [ Time Frame: Entire operation duration ]
    The amount of intraoperative blood transfusion

  3. Operative time [ Time Frame: Entire operation duration ]
    The time from induction of anesthesia to the closure of abdomen

  4. Postoperative intensive-care unit (ICU) stay [ Time Frame: Duration of stay in ICU ]
    Duration of stay in ICU

  5. Hospital stay [ Time Frame: Duration of hospital stay ]
    Duration of hospital stay

  6. Total hospital expenditure [ Time Frame: Duration of hospital stay ]
    Total costs during hospital stay

  7. Perioperative systemic inflammatory response [ Time Frame: an expected average of 7 days ]
    Perioperative systemic inflammatory response is characterized by elevated serum level of tumor necrosis factor-α (TNF-α), interleukins (IL)-1α, 2, 6, 8 and 10, procalcitonin (PCT) and C-reactive protein (CRP) at different time points.

  8. Postoperative morbi-mortality [ Time Frame: an expected average of 12 days in hospital ]
    Postoperative morbi-mortality is characterized by postoperative complication and its severity based on Clavien-Dindo classification and in-hospital mortality

  9. Long-term oncologic outcomes [ Time Frame: 5 years after operation ]
    1, 3, 5-year tumor recurrence rate

  10. Long-term survival [ Time Frame: 5 years after operation ]
    1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563158


Contacts
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Contact: Shichun Lu, MD, PhD +86 10 68160801 sclu_301@163.com
Contact: Yinzhe Xu, MD, PhD +1 617 818 4081 james_hbp@163.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Yinzhe Xu, M.D., Ph.D.    86-10-66936609    james_hbp@163.com   
Principal Investigator: Shichun Lu, M.D., Ph.D.         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Shichun Lu, MD, PhD Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Shichun Lu, Director, Department of Hepatobiliary Surgery, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02563158     History of Changes
Other Study ID Numbers: JFJZYY-GD-15-01
NO. 2012BAI06B01 ( Other Grant/Funding Number: National Key Technology R&D Program of China )
NO. 2012ZX10002-017 ( Other Grant/Funding Number: National S&T Major Project for Infectious Diseases of China )
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Prof. Shichun Lu, Chinese PLA General Hospital:
liver resection
blood inflow control
ischemia-reperfusion injury
inflammatory response
randomized controlled trial

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases