Open Versus Laparoscopic Left-sided Hepatectomy Trial

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

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

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.

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