Open Versus Laparoscopic Left-sided Hepatectomy Trial (OLLEH)

Ewha Womans University

Status and phase: Unknown; Phase 3

Conditions: Neoplasm, Liver

Treatments: Procedure: Open left-sided hepatectomy; Procedure: Laparoscopic left-sided hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03010085

OLLEH trial

Details and patient eligibility

About

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

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

A (Open left-sided hepatectomy)

Active Comparator group

Description:

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

Treatment:

Procedure: Open left-sided hepatectomy

B (Laparoscopic left-sided hepatectomy)

Experimental group

Description:

Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy

Treatment:

Procedure: Laparoscopic left-sided hepatectomy