Clinical trial NCT03010085: Open Versus Laparoscopic Left-sided Hepatectomy Trial
Official title: A Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Left-sided Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neoplasm, Liver
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
Collaborators: name: Korea Cancer Center Hospital
name: Seoul National University Boramae Hospital
name: Eulji University Hospital
name: Bucheon St. Mary's Hospital
name: Gyeongsang National University Hospital
name: Jeju National University Hospital
name: The Catholic University of Korea
name: Soonchunhyang University Hospital
name: Inje University
name: Pusan National University Hospital
name: DongGuk University
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Chonnam National University Hospital
name: Hallym University Kangnam Sacred Heart Hospital
name: Hallym University Medical Center
name: Seoul St. Mary's Hospital
First posted: 2017-01-04
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
timeFrame: up to 30 days
Secondary outcomes:
measure: Postoperative complication
timeFrame: up to 30 days
measure: Mortality
timeFrame: up to 30 days
measure: Readmission rate
timeFrame: up to 30 days
measure: Hospital duration
timeFrame: up to 30 days
measure: Blood loss
timeFrame: up to 30 days
measure: Operation time
timeFrame: up to 30 days
measure: Resection margin status
timeFrame: up to 30 days
measure: Liver function test
timeFrame: up to 30 days
measure: Quality of life
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
References: