A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

NCT00851968 | Completed DMC

• 1 other identifier: EHBH-RCT-2008-008
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative bleeding remains a major concern during liver resection. Pringle maneuver is the most frequently used method to occlude inflow blood of the liver.However, experimental and clinical studies have shown than even short periods of clamping produce some degree of ischemia-reperfusion injury that can result in hepatocellular damage,this damage being especially important in patients with abnormal liver parenchyma such as steatosis and cirrhosis. The aim of this study was to evaluate whether the use of selective vascular clamping should be generalized to HCC patients and help to reduce the ischemia-reperfusion injury.

Conditions

Hepatocellular Carcinoma

Keywords

hepatectomy; Selective HepaticVascular Clamping

Outcome Measures

Primary Outcomes (1)

• overall survival

  2010

Secondary Outcomes (1)

• serum alanine aminotransferase (ALT), bilirubin, prothrombin time, serum albumin and pre-albumin on postoperative 1, 3, 7 day, resection rate, procedure-related complications and hospital mortality,expression of HIF and P-, E-, and L-selectin

  2010

Study Arms (3)

Pringle's Maneuver

ACTIVE COMPARATOR

Patients with HCC received Pringle's Maneuver in hepatectomy.

Procedure: Pringle's Maneuver

Hemihepatic vascular Clamping

EXPERIMENTAL

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy

Procedure: Hemihepatic vascular Clamping

portal vein occlusion

EXPERIMENTAL

Patients with HCC received portal vein occlusion in hepatectomy

Procedure: Portal vein occlusion

Interventions

Pringle's Maneuver PROCEDURE

The entire hilar pedicle was encircled with a rubber tape to perform a Pringle maneuver with a tourniquet.

Also known as: Pringle's Maneuver group

Pringle's Maneuver

Hemihepatic vascular Clamping PROCEDURE

The portal vein,hepatic artery ,and biliary duct were dissected in the hilum by opening the peritoneal fascia. Either the right or left portal pedicle was isolated and encircled with a tourniquet or clamped with Shatinsky clamp. Separate clamping of accessory left hepatic artery was performed when present in controlling the left hemihepatic portal traid.

Also known as: Hemihepatic vascular Clamping group

Hemihepatic vascular Clamping

Portal vein occlusion PROCEDURE

The proper hepatic artery was dissected first from the duodenohepatic ligament, portal pedicle was blocked with a rubber encircled through the posterior wall of proper hepatic artery and the bottom of duodenohepatic ligament.When aberrant hepatic arteries emerging from the superior mesenteric artery are found in duodenohepatic ligament ,they should be dissected and kept unobstructed.

Also known as: Portal vein occlusion group

portal vein occlusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with a clinical diagnosis of primary liver cancer, without any adjuvant therapy;
• age:18-70years;
• suitable for partial hepatectomy without other malignancies;
• compensated cirrhosis with Child-Pugh class A, or B.

You may not qualify if:

• reject to attend；
• with any preoperative adjuvant therapy.
• with intrahepatic or extrahepatic malignancies;
• cirrhosis with Child-Pugh class C

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Shen feng, MD

  Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 26, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)