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Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

NCT ID: NCT03672357

Last Updated: 2018-12-13

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-04-01

Brief Summary

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LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, due to the concerns over the risk of operative bleeding, tumor seeding and positive resection margin, the true benefit of LLR remains unclear across surgical community.

Detailed Description

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The 2nd International Consensus Conference on Laparoscopic Liver Resection (ICCLLR) was held in Morioka, Japan, in 2014. The new recommendations of the ICCLLR state that the outcomes of LLR are not inferior than OLR regarding to operative mortality rate and margin negativity, and are superior in decreasing postoperative complications, blood loss, and the length of the postoperative hospital stay. However, it is not clear that whether LLR is able to alleviate the impairment of liver function after hepatic resection, and there is no RCTs to compare the short and long outcomes between LLR and OLR.

Conditions

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Laparoscopic Liver Resection Open Liver Resection

Keywords

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Liver resection Laparoscopic surgery fast recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Laparoscopic liver resection

Laparoscopic hepatectomy

Group Type EXPERIMENTAL

Laparoscopic liver resection

Intervention Type PROCEDURE

Laparoscopic hepatectomy

Open liver resection

Open hepatectomy

Group Type OTHER

Open liver resection

Intervention Type PROCEDURE

Traditional open hepatectomy

Interventions

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Laparoscopic liver resection

Laparoscopic hepatectomy

Intervention Type PROCEDURE

Open liver resection

Traditional open hepatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for both open and laparoscopic liver resection;
2. Child-Pugh A without portal hypertension
3. No portosystemic shunt
4. No previous abdominal operation history.
5. American society of anesthesiology class(ASA): I or II
6. Age 18 to 80

Exclusion Criteria

1. Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
2. Combined hepatectomy
3. Intrahepatic duct stone disease
4. Liver disease caused splenomegaly
5. Previous hepatectomy
6. Combined operation for extrahepatic disease
7. Vulnerable population (mental retardation, pregnancy)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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hui hou

OTHER

Sponsor Role lead

Responsible Party

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hui hou

Director of the hepatobiliary surgery department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The second hospital of Anhui Medical University,

Hefei, Anhui, China

Site Status

Countries

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China

Central Contacts

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dachen zhou, MD

Role: CONTACT

Phone: +8618160885015

Email: [email protected]

Other Identifiers

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LLR_01

Identifier Type: -

Identifier Source: org_study_id