Clinical trial NCT02405416: Infrahepatic Inferior Vena Cava Clamping Versus Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping
Official title: A Prospective Randomized Controlled Trial to Compare Infrahepatic Inferior Vena Cava Clamping With Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping in Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Neoplasms
Liver Cirrhosis
Keywords: Hepatocellular Carcinoma
Blood Loss
Haemorrhage
Vascular Control
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another equivalent group patients will be operated using SHVE and PTC.

Detailed description: Intraoperative blood loss is significantly associated with clinical outcomes of patients undergoing hepatectomy. There have been various hepatic vascular control techniques, including infrahepatic inferior vena cava clamping (IIVCC) and selective hepatic vascular exclusion (SHVE).The propose of this study is to compare these two surgical techniques combined with the portal triad clamping (PTC) in hepatic cirrhotic patients. All patients being performed hepatectomy at the center are scanned according to inclusion and exclusion criteria. After intraoperative exploration, patients are randomized into two interventional groups. PTC, IIVCC or SHVE is performed at the specified timepoint in liver parenchymal transection in two different groups. All data are collected prospectively.

Eligibility criteria: Inclusion Criteria:

1. either male or female, older than 18 (include 18).
2. tumors oppress or be in close proximity to one or more of major hepatic veins.
3. the maximum diameter of tumor ≥ 5cm, number of lesions ≤ 3 and should be in same liver lobe if multiple lesions exit.
4. preoperative liver function assessment: Child-Pugh classification is A or B.
5. preoperative laboratory test: blood platlet count \> 100×10\^9/l, prothrombin activity \> 60%.
6. liver cirrhosis.

Exclusion Criteria:

1. contraindication for surgery,e.g.severe disorders of circulation, respiratory or renal system.
2. extrahepatic metastasis in patients with malignancy or tumor invasion of portal vein, hepatic vein, bile duct or inferior vena cava.
3. hepatectomy accompanied with other organs resection(e.g. bile duct, intestine, pancreas or stomach)
4. regular hepatectomy.
5. tumors located in the left lateral lobe of liver.
6. previous hepatectomy.
7. pregnancy or lactation.
8. refusal to participate this trial.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: Intraoperative period
measure: Normalized transection-related blood loss
timeFrame: Intraoperative period
Secondary outcomes:
measure: Time of infrahepatic inferior vena cava or selected hepatic vein dissection
timeFrame: Intraoperative period
measure: Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure
timeFrame: Intraoperative period
measure: Drop of hemoglobin level
timeFrame: Drop of hemoglobin level will be measured during liver parenchymal transection period(neither the specific time point nor expected average could be given prospectively because of different surgical situations)
measure: Postrecovery of liver function
timeFrame: postoperative days 1, 3, 5, 7
measure: Postrecovery of renal function
timeFrame: postoperative days 1, 3, 5, 7
measure: Morbidity of postoperative complications
timeFrame: 90 days after surgery
measure: Postoperative mortality
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiaoping Chen, M.D.
role: STUDY_CHAIR
References: