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Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pringle
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatectomy, vascular inflow occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18
  • Child's A or B cirrhosis

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, lipiodol-ethanol mixture injection or transarterial internal radiation
  • Anticipation of portal vein resection
  • Emergency hepatectomy
  • Ruptured HCC
  • Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
  • Anticipation of concomitant bowel or bile duct resection

Sites / Locations

  • The Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pringle

Non-Pringle

Arm Description

Intermittent vascular inflow occlusion applied during liver resection

No vascular inflow occlusion applied during liver resection

Outcomes

Primary Outcome Measures

Post-operative surgical complications
30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection

Secondary Outcome Measures

Other post-operative complications
post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay
Survival
Overall and disease-free survival at 1, 3, 5-year
Recurrence rate of hepatocellular carcinoma
Recurrence rate of hepatocellular carcinoma at 1,3,5 year

Full Information

First Posted
January 1, 2013
Last Updated
March 5, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01759901
Brief Title
Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma
Official Title
Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction. The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate. The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma. Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatectomy, vascular inflow occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pringle
Arm Type
Experimental
Arm Description
Intermittent vascular inflow occlusion applied during liver resection
Arm Title
Non-Pringle
Arm Type
No Intervention
Arm Description
No vascular inflow occlusion applied during liver resection
Intervention Type
Procedure
Intervention Name(s)
Pringle
Other Intervention Name(s)
Vascular inflow occlusion
Intervention Description
Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval
Primary Outcome Measure Information:
Title
Post-operative surgical complications
Description
30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Other post-operative complications
Description
post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay
Time Frame
1 month
Title
Survival
Description
Overall and disease-free survival at 1, 3, 5-year
Time Frame
5 year
Title
Recurrence rate of hepatocellular carcinoma
Description
Recurrence rate of hepatocellular carcinoma at 1,3,5 year
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 Child's A or B cirrhosis 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, lipiodol-ethanol mixture injection or transarterial internal radiation Anticipation of portal vein resection Emergency hepatectomy Ruptured HCC Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver Anticipation of concomitant bowel or bile duct resection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kit Fai Lee, MBBS
Organizational Affiliation
Clinical Associate Professor (honorary)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31420724
Citation
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.
Results Reference
derived
PubMed Identifier
29696328
Citation
Lee KF, Wong J, Cheung SYS, Chong CCN, Hui JWY, Leung VYF, Yu SCH, Lai PBS. Does Intermittent Pringle Maneuver Increase Postoperative Complications After Hepatectomy for Hepatocellular Carcinoma? A Randomized Controlled Trial. World J Surg. 2018 Oct;42(10):3302-3311. doi: 10.1007/s00268-018-4637-3.
Results Reference
derived

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Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma

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