Infrahepatic Inferior Vena Cava Clamping Versus Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02405416
• Other study ID #: chenxp006
• Secondary ID: 2012ZX10002016-0
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2015
• Last updated: March 31, 2015
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2015
• Source: Huazhong University of Science and Technology
• Contact: Xiaoping Chen, M.D.
• Phone: +86 27 83662851
• Email: chenxp[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Neoplasms

Intervention

Procedure:
• Infrahepatic inferior vena cava clamping
Infrahepatic inferior vena cava is clamped in hepatectomy.
• Selective hepatic vascular exclusion
Selected major hepatic vein is clamped in hepatectomy.
• Portal triad clamping
Portal triad are clamped in hepatectomy.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss	blood loss from incision to closure	Intraoperative period	No
Primary	Normalized transection-related blood loss	Intraoperative blood loss normalized by transection surface area	Intraoperative period	No
Secondary	Time of infrahepatic inferior vena cava or selected hepatic vein dissection	Time cost of dissection	Intraoperative period	Yes
Secondary	Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure		Intraoperative period	Yes
Secondary	Drop of hemoglobin level		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)	No
Secondary	Postrecovery of liver function	Liver function evaluation is composite of liver enzyme ,total bilirubin, prothrombin activity, etc.	postoperative days 1, 3, 5, 7	Yes
Secondary	Postrecovery of renal function	Renal function evaluation is composite of blood urea nitrogen, creatinine, etc.	postoperative days 1, 3, 5, 7	Yes
Secondary	Morbidity of postoperative complications		90 days after surgery	No
Secondary	Postoperative mortality		90 days after surgery	No