Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

NCT03672357 | Unknown

• 1 other identifier: LLR_01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Liver Resection; Open Liver Resection

Keywords

Liver resection; Laparoscopic surgery; fast recovery

Outcome Measures

Primary Outcomes (2)

• Change of serum glutamic oxalacetic transaminase

  Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.

  up to 7 days after liver resection

• Change of serum glutamic-pyruvic transaminase

  Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.

  up to 7 days after liver resection

Secondary Outcomes (17)

• Postoperative complication(Rates in different grades)

  up to 30 days after liver resection

• Mortality rates

  up to 30 days after liver resection

• Hospital duration after operation (days)

  up to 30 days after liver resection

• Operation time(min)

  up to 30 days after liver resection

• Blood loss(ml)

  up to 30 days after liver resection

Study Arms (2)

Laparoscopic liver resection

EXPERIMENTAL

Laparoscopic hepatectomy

Procedure: Laparoscopic liver resection

Open liver resection

OTHER

Open hepatectomy

Procedure: Open liver resection

Interventions

Laparoscopic liver resection PROCEDURE

Laparoscopic hepatectomy

Laparoscopic liver resection

Open liver resection PROCEDURE

Traditional open hepatectomy

Open liver resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
• Combined hepatectomy
• Intrahepatic duct stone disease
• Liver disease caused splenomegaly
• Previous hepatectomy
• Combined operation for extrahepatic disease
• Vulnerable population (mental retardation, pregnancy)

Sponsors & Collaborators

• hui hou: lead

Study Sites (1)

The second hospital of Anhui Medical University,

Hefei, Anhui, 230061, China

Location

Central Study Contacts

dachen zhou, MD

CONTACT

+8618160885015; zdc1987@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the hepatobiliary surgery department

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: September 14, 2018
• Study Start: January 1, 2019
• Primary Completion: September 1, 2024
• Study Completion: April 1, 2025
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)