Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC (OHx-NOHx)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Surgery||Procedure: non-occlusion technique||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- Serum total bilirubin on postoperative day 5 [ Time Frame: 5 days ]Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.
- Intraoperative blood loss [ Time Frame: Entire operation duration ]Total blood loss from the incision to the closure of abdomen
- Requirement of blood transfusion [ Time Frame: Entire operation duration ]The amount of intraoperative blood transfusion
- Operative time [ Time Frame: Entire operation duration ]The time from induction of anesthesia to the closure of abdomen
- Postoperative intensive-care unit (ICU) stay [ Time Frame: Duration of stay in ICU ]Duration of stay in ICU
- Hospital stay [ Time Frame: Duration of hospital stay ]Duration of hospital stay
- Total hospital expenditure [ Time Frame: Duration of hospital stay ]Total costs during hospital stay
- 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.
- 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
- Long-term oncologic outcomes [ Time Frame: 5 years after operation ]1, 3, 5-year tumor recurrence rate
- Long-term survival [ Time Frame: 5 years after operation ]1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)
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
|Contact: Shichun Lu, MD, PhD||+86 10 email@example.com|
|Contact: Yinzhe Xu, MD, PhD||+1 617 818 firstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Yinzhe Xu, M.D., Ph.D. 86-10-66936609 email@example.com|
|Principal Investigator: Shichun Lu, M.D., Ph.D.|
|Principal Investigator:||Shichun Lu, MD, PhD||Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China|