Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

Study Overview
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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.

Official Title
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Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

Conditions
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Laparoscopic Liver Resection, Open Liver Resection

Intervention / Treatment
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* Procedure: Laparoscopic liver resection
* Procedure: Open liver resection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic liver resection<br>Laparoscopic hepatectomy | Procedure: Laparoscopic liver resection<br>* Laparoscopic hepatectomy<br>|
| Other: Open liver resection<br>Open hepatectomy | Procedure: Open liver resection<br>* Traditional open hepatectomy<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Mortality rates | the rate of postoperative death | up to 30 days after liver resection | 
| Hospital duration after operation (days) | the length of hospital stay | up to 30 days after liver resection | 
| Operation time(min) | the during of operation | 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 | 
| Duration of nasogastric tubes (hours) | Duration of nasogastric tubes | up to 14 days after liver resection7 | 
| 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 | 
| 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 | 
| C-reactive protein (mg/mL) | C-reactive protein levels on preoperative and postoperative day-1,3,5 | up to 5 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver resection, Laparoscopic surgery, fast recovery