Open Versus Laparoscopic Left-sided Hepatectomy Trial

Study Overview
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Brief Summary
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Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional, prospective and randomized trial in patients undergoing left sided hepatectomy through laparoscopic versus open procedure. Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood loss, operation time, resection margin status, postoperative complication, mortality, liver function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness

Detailed Description
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Laparoscopic left-sided hepatectomy is widely performed for the treatment of various hepatic neoplasms. Many studies have reported that laparoscopic left-sided hepatectomy is safe and effective compared with open conventional left-sided hemihepatectomy. However, prospective study is rare and there is no randomized controlled trial. The surgeons who are affiliated at a medical center in capital area of Korea launched the Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial to verify the surgical outcome of laparoscopic left-sided hepatectomy. Laparoscopic surgery has benefits that less wound and less pain. The hypothesis of the study is 'The laparoscopic left-sided hemihepatectomy is better than open surgery from functional recovery.

Official Title
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A Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Left-sided Hepatectomy

Conditions
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Neoplasm, Liver

Intervention / Treatment
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* Procedure: Open left-sided hepatectomy
* Procedure: Laparoscopic left-sided hepatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who underwent open or laparoscopic left-sided hepatectomy for benign or malignant neoplasm of the liver Child-Pugh A without portal hypertension No portosystemic shunt No splenomegaly Platelet count >100,000/ul Age 18 to 80 Eastern Cooperative Oncology Group performance status: 0 or 1 American society of anesthesiology class: I or II Informed consent Exclusion Criteria: Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others) Combined hepatectomy Bile duct reconstruction Intrahepatic duct stone Upper abdominal laparotomy history Previous hepatectomy Combined operation for extrahepatic disease Vulnerable population (mental retardation, pregnancy) Patient who participated in other clinical trial within 6 months

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A (Open left-sided hepatectomy)<br>Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy | Procedure: Open left-sided hepatectomy<br>* Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy<br>* Other names: Left hemihepatectomy;|
| Experimental: B (Laparoscopic left-sided hepatectomy)<br>Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy | Procedure: Laparoscopic left-sided hepatectomy<br>* Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy<br>* Other names: Laparoscopic left hemihepatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase) | Checklist of functional recovery (Questionnaire) Do you want intravenous analgesics for postoperative pain ? (Yes, No) (Questionnaire) Do you have trouble to ambulate by oneself ? (Yes, No) (Questionnaire) Do you have trouble to digest solid meal ? (Yes, No) (Questionnaire) Do you want intravenous fluid to subside your thirsty ? (Yes, No) (Liver function test) Are serum aspartate aminotransferase and alanine aminotransferase increasing ? (Yes, No) Daily check the five item above until every item is 'No' If all of the items are 'No', the patient is regarded as a functionally recovered state. | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication | Discharge summary | up to 30 days | 
| Mortality | Death within 30 days after surgery | up to 30 days | 
| Readmission rate | Readmission | up to 30 days | 
| Hospital duration | Hospital duration after surgery | up to 30 days | 
| Blood loss | Estimated blood loss on anesthesiology sheet | up to 30 days | 
| Operation time | Skin incision to wound closure | up to 30 days | 
| Resection margin status | According to the pathology report | up to 30 days | 
| Liver function test | Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin | up to 30 days | 
| Quality of life | questionnaire | up to 30 days |