Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Liver Resection; Open Liver Resection
• Intervention / Treatment: Procedure: Laparoscopic liver resection; Procedure: Open liver resection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: dachen zhou, MD; Phone Number: +8618160885015; Email: zdc1987@yeah.net

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230061
      • The second hospital of Anhui Medical University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic liver resection; Laparoscopic hepatectomy	Procedure: Laparoscopic liver resection; Laparoscopic hepatectomy
Other: Open liver resection; Open hepatectomy	Procedure: Open liver resection; Traditional open hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital duration after operation (days)	the length of hospital stay	up to 30 days after liver resection
Mortality rates	the rate of postoperative death	up to 30 days after liver resection
Blood loss(ml)	the volume of blood loss	up to 30 days after liver resection
Blood transfusion (times and units)	intraoperative blood transfusion	intraoperative
C-reactive protein (mg/mL)	C-reactive protein levels on preoperative and postoperative day-1,3,5	up to 5 days after liver resection
Duration of abdominal drain (days)	Duration of abdominal drain	up to 14 days after liver resection
Duration to first flatus (days)	Duration to first flatus	up to 14 days after liver resection
Postoperative complication(Rates in different grades)	According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/	up to 30 days after liver resection
Operation time(min)	the during of operation	up to 30 days after liver resection
Duration of nasogastric tubes (hours)	Duration of nasogastric tubes	up to 14 days after liver resection7
Comfort questionnaire measures (GCQ) measures by Kolcaba	GCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html.	up to 7 days after liver resection
Resection margin status	the R0 resection rate	up to 30 days after liver resection
Intensive care unit stay (days)	Intensive care unit stay in days	up to 7 days after liver resection
Readmission rate	measure the rate of readmission	up to 30 days after liver resection
Disease recurrence rates	The disease recurrence after operation	up to 5 years
Overall survival time (month)	Overall survival time after operation	up to 5 years after operation
Disease free survival time (month)	Disease free survival time after operation	up to 5 years after operation

Collaborators and Investigators

• Sponsor: hui hou

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: August 19, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Liver resection; fast recovery
• Additional Relevant MeSH Terms: Hematinics; Liver Extracts
• Other Study ID Numbers: LLR_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No