Study on Clinical Outcome of Vascular Inflow Occlusion in Open Liver Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-08-31

Brief Summary

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This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.

Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.

Patients outcome including liver function recovery, operative time and blood loss are compared.

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Detailed Description

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Conditions

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Hepatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Intermittent clamp group

Group Type EXPERIMENTAL

Intermittent Pringle maneuver

Intervention Type PROCEDURE

Pringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver.

2

No clamp group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intermittent Pringle maneuver

Pringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Child-Pugh Class A or B

Exclusion Criteria

* Informed consent not available
* Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation
* Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, or transarterial internal radiation
* When portal vein resection is anticipated
* Emergency hepatectomy
* Ruptured hepatocellular carcinoma
* Rehepatectomy (repeated liver resection)
* Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
* When concomitant bowel or bile duct resection is anticipated

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No