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

NCT02405416 | Unknown DMC

• 2 other identifiers: chenxp0062012ZX10002016-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Neoplasms; Liver Cirrhosis

Keywords

Hepatocellular Carcinoma; Blood Loss; Haemorrhage; Vascular Control

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood loss

  blood loss from incision to closure

  Intraoperative period

• Normalized transection-related blood loss

  Intraoperative blood loss normalized by transection surface area

  Intraoperative period

Secondary Outcomes (7)

• Time of infrahepatic inferior vena cava or selected hepatic vein dissection

  Intraoperative period

• Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure

  Intraoperative period

• 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)

• Postrecovery of liver function

  postoperative days 1, 3, 5, 7

• Postrecovery of renal function

  postoperative days 1, 3, 5, 7

Study Arms (2)

IIVCC group

EXPERIMENTAL

The portal triad and infrahepatic inferior vena cava are dissected and taped with a vessel loop, respectively. During liver parenchymal resection，portal triad and infrahepatic inferior vena cava clampings are performed at the specified transection depth from liver surface successively.

Procedure: Infrahepatic inferior vena cava clamping; Procedure: Portal triad clamping

SHVE group

ACTIVE COMPARATOR

In this group, the portal triad clamping and selective hepatic vascular exclusion of major hepatic veins are used. Different major hepatic veins are occluded by clamping forcep depending on the site of tumors. The clamping timepoints are same as the IIVCC group.

Procedure: Selective hepatic vascular exclusion; Procedure: Portal triad clamping

Interventions

Infrahepatic inferior vena cava clamping PROCEDURE

Infrahepatic inferior vena cava is clamped in hepatectomy.

Also known as: IIVCC

IIVCC group

Selective hepatic vascular exclusion PROCEDURE

Selected major hepatic vein is clamped in hepatectomy.

Also known as: SHVE

SHVE group

Portal triad clamping PROCEDURE

Portal triad are clamped in hepatectomy.

Also known as: PTC

IIVCC group; SHVE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Liver Cirrhosis; Carcinoma, Hepatocellular; Hemorrhage

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Xiaoping Chen, M.D.

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Xiaoping Chen, M.D.

CONTACT

+86 27 83662851; chenxp@medmail.com.cn

Chao Wu, M.M.

CONTACT

+8618986136006; dr_wuchao@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Professor of Department of Surgery

Study Record Dates

• First Submitted: March 7, 2015
• First Posted: April 1, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

CN (1)