Short and Long Outcomes Between Laparoscopic and Open Hepatectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laparoscopic Liver Resection
- Sponsor
- hui hou
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change of serum glutamic oxalacetic transaminase
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
hui hou
Director of the hepatobiliary surgery department
The Second Hospital of Anhui Medical University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Change of serum glutamic oxalacetic transaminase
Time Frame: up to 7 days after liver resection
Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
Change of serum glutamic-pyruvic transaminase
Time Frame: up to 7 days after liver resection
Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
Secondary Outcomes
- 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)
- Intensive care unit stay (days)(up to 7 days after liver resection)
- Blood transfusion (times and units)(intraoperative)
- Duration of nasogastric tubes (hours)(up to 14 days after liver resection7)
- Duration to first flatus (days)(up to 14 days after liver resection)
- Resection margin status(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)
- Duration of abdominal drain (days)(up to 14 days after liver resection)
- Comfort questionnaire measures (GCQ) measures by Kolcaba(up to 7 days after liver resection)
- Readmission rate(up to 30 days after liver resection)
- C-reactive protein (mg/mL)(up to 5 days after liver resection)
- Disease recurrence rates(up to 5 years)
- Overall survival time (month)(up to 5 years after operation)
- Disease free survival time (month)(up to 5 years after operation)