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

NCT00730743 | Completed

• 2 other identifiers: CT08017CRE-2008.037-T
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatectomy

Outcome Measures

Primary Outcomes (2)

• Operative blood loss

  From skin incision to completion of operation

• Operative time

  From skin incision to completion of operation

Secondary Outcomes (2)

• Operative morbidity and mortality

  From date of operation to 30-day after operation

• Recovery of liver function

  From date of operation to date of discharge

Study Arms (2)

1

EXPERIMENTAL

Intermittent clamp group

Procedure: Intermittent Pringle maneuver

2

NO INTERVENTION

No clamp group

Interventions

Intermittent Pringle maneuver 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.

1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (2)

• Lee KF, Chong CCN, Cheung SYS, Wong J, Fung AKY, Lok HT, Lai PBS. Impact of Intermittent Pringle Maneuver on Long-Term Survival After Hepatectomy for Hepatocellular Carcinoma: Result from Two Combined Randomized Controlled Trials. World J Surg. 2019 Dec;43(12):3101-3109. doi: 10.1007/s00268-019-05130-8.

  PMID: 31420724 DERIVED

• Lee KF, Cheung YS, Wong J, Chong CC, Wong JS, Lai PB. Randomized clinical trial of open hepatectomy with or without intermittent Pringle manoeuvre. Br J Surg. 2012 Sep;99(9):1203-9. doi: 10.1002/bjs.8863. Epub 2012 Jul 24.

  PMID: 22828986 DERIVED

Study Officials

• Kit-fai Lee, MBBS

  Departement of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

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: Associate Consultant

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

CN (1)