Neoplasm, Liver
Conditions
Brief summary
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
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.
Interventions
PROCEDUREOpen left-sided hepatectomy
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
PROCEDURELaparoscopic left-sided hepatectomy
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
Sponsors
Korea Cancer Center Hospital
Seoul National University Boramae Hospital
Eulji University Hospital
Bucheon St. Mary's Hospital
Gyeongsang National University Hospital
Jeju National University Hospital
The Catholic University of Korea
Soonchunhyang University Hospital
Inje University
Pusan National University Hospital
DongGuk University
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Chonnam National University Hospital
Hallym University Kangnam Sacred Heart Hospital
Hallym University Medical Center
Seoul St. Mary's Hospital
Ewha Womans University Mokdong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient who underwent open or laparoscopic left-sided hepatectomy for benign or malignant neoplasm of the liver 2. Child-Pugh A without portal hypertension * No portosystemic shunt * No splenomegaly * Platelet count \>100,000/ul 3. Age 18 to 80 4. Eastern Cooperative Oncology Group performance status: 0 or 1 5. American society of anesthesiology class: I or II 6. Informed consent
Exclusion criteria
1. Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others) 2. Combined hepatectomy 3. Bile duct reconstruction 4. Intrahepatic duct stone 5. Upper abdominal laparotomy history 6. Previous hepatectomy 7. Combined operation for extrahepatic disease 8. Vulnerable population (mental retardation, pregnancy) 9. Patient who participated in other clinical trial within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase) | up to 30 days | Checklist of functional recovery 1. (Questionnaire) Do you want intravenous analgesics for postoperative pain ? (Yes, No) 2. (Questionnaire) Do you have trouble to ambulate by oneself ? (Yes, No) 3. (Questionnaire) Do you have trouble to digest solid meal ? (Yes, No) 4. (Questionnaire) Do you want intravenous fluid to subside your thirsty ? (Yes, No) 5. (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | up to 30 days | Death within 30 days after surgery |
| Readmission rate | up to 30 days | Readmission |
| Hospital duration | up to 30 days | Hospital duration after surgery |
| Blood loss | up to 30 days | Estimated blood loss on anesthesiology sheet |
| Postoperative complication | up to 30 days | Discharge summary |
| Resection margin status | up to 30 days | According to the pathology report |
| Liver function test | up to 30 days | Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin |
| Quality of life | up to 30 days | questionnaire |
| Operation time | up to 30 days | Skin incision to wound closure |
Countries
South Korea
Contacts
Primary ContactSeung Duk Lee, MD
Backup ContactYunsung Seo, MS
Outcome results
None listed