Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

Laparoscopic Liver Resection Clinical Trial

Official title:

Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03672357
• Other study ID #: LLR_01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 1, 2025

Study information

• Verified date: December 2018
• Source: The Second Hospital of Anhui Medical University
• Contact: dachen zhou, MD
• Phone: +8618160885015
• Email: zdc1987[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopic Liver Resection
• Open Liver Resection

Intervention

Procedure:
• Laparoscopic liver resection
Laparoscopic hepatectomy
• Open liver resection
Traditional open hepatectomy

Locations

Country	Name	City	State
China	The second hospital of Anhui Medical University,	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
hui hou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Mortality rates	the rate of postoperative death	up to 30 days after liver resection
Secondary	Hospital duration after operation (days)	the length of hospital stay	up to 30 days after liver resection
Secondary	Operation time(min)	the during of operation	up to 30 days after liver resection
Secondary	Blood loss(ml)	the volume of blood loss	up to 30 days after liver resection
Secondary	Blood transfusion (times and units)	intraoperative blood transfusion	intraoperative
Secondary	Duration of nasogastric tubes (hours)	Duration of nasogastric tubes	up to 14 days after liver resection7
Secondary	Duration of abdominal drain (days)	Duration of abdominal drain	up to 14 days after liver resection
Secondary	Duration to first flatus (days)	Duration to first flatus	up to 14 days after liver resection
Secondary	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
Secondary	Resection margin status	the R0 resection rate	up to 30 days after liver resection
Secondary	Intensive care unit stay (days)	Intensive care unit stay in days	up to 7 days after liver resection
Secondary	Readmission rate	measure the rate of readmission	up to 30 days after liver resection
Secondary	C-reactive protein (mg/mL)	C-reactive protein levels on preoperative and postoperative day-1,3,5	up to 5 days after liver resection
Secondary	Disease recurrence rates	The disease recurrence after operation	up to 5 years
Secondary	Overall survival time (month)	Overall survival time after operation	up to 5 years after operation
Secondary	Disease free survival time (month)	Disease free survival time after operation	up to 5 years after operation