Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

NCT ID: NCT02319863

Last Updated: 2014-12-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-02-28

Study Completion Date

2014-12-31

Brief Summary

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This study examines the role of this simple technique on postoperative metastasis and long term survival.

Detailed Description

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The only hope of long-term survival for patients with primary hepatocellular carcinoma (HCC) is surgical resection or liver transplantation, the former of which is more feasible at present. However, postoperative recurrence or metastasis is an ominous feature for this disease. Innovation of the surgical procedure for improving prognosis is under emergency request. This study examines the role of this simple technique on postoperative metastasis and long term survival.

During the past 20 years, more 600 patients with primary HCC were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (RCT) was applied. We further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.

Conditions

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Cancer Progression

Keywords

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hepatocellular carcinoma prognosis

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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conventional resection

Perform hepatectomy with conventional method for HCC patients.

Group Type ACTIVE_COMPARATOR

hepatectomy (conventional method)

Intervention Type PROCEDURE

A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

new method

The new technique of rapid ligating the corresponding inflow and outflow vessels without hills dissection before parenchyma transection during hepatectomy.

Group Type EXPERIMENTAL

hepatectomy (rapid ligating)

Intervention Type PROCEDURE

Interventions

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hepatectomy (conventional method)

A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

Intervention Type PROCEDURE

hepatectomy (rapid ligating)

Intervention Type PROCEDURE

Other Intervention Names

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liver resection

Eligibility Criteria

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Inclusion Criteria

* HCC patients who will perform left- or right- hemihepatectomy.

Exclusion Criteria

1. contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)\>30%,serum hepatitis B virus (HBV)-DNA\>106 copies/ml and serum alanine aminotransferase (ALT)\>2×ULN, serum triglycerides\>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause;
2. pregnancy;
3. age of\<18y or\>65y
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xiaoping Chen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoping Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoping Chen, M.D.

Role: CONTACT

Phone: +86 27 83662851

Email: [email protected]

Binhao Zhang, M.D.

Role: CONTACT

Phone: +86 15802726021

Email: [email protected]

Facility Contacts

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Xiaoping Chen, M.D.

Role: primary

Binhao Zhang, M.D.

Role: backup

References

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Chen XP, Qiu FZ. A simple technique ligating the corresponding inflow and outflow vessels during anatomical left hepatectomy. Langenbecks Arch Surg. 2008 Mar;393(2):227-30; discussion 231-4. doi: 10.1007/s00423-007-0224-z. Epub 2007 Nov 3.

Reference Type BACKGROUND
PMID: 17978838 (View on PubMed)

Other Identifiers

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2012ZX10002016-004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Chenxp5

Identifier Type: -

Identifier Source: org_study_id