Open Versus Laparoscopic Left-sided Hepatectomy Trial

Phase 3

• Conditions: Neoplasm, Liver
• Interventions: Procedure: Laparoscopic left-sided hepatectomy; Procedure: Open left-sided hepatectomy

• Registration Number: NCT03010085
• Lead Sponsor: Ewha Womans University Mokdong Hospital

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.

Study Timeline

• Study First Submitted: 2016-11-30
• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-02
• Last Update Submitted: 2017-01-02
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04
• Primary Completion: 2019-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B (Laparoscopic left-sided hepatectomy)	Laparoscopic left-sided hepatectomy	Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
A (Open left-sided hepatectomy)	Open 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Blood loss	up to 30 days	Estimated blood loss on anesthesiology sheet
Postoperative complication	up to 30 days	Discharge summary
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
Readmission rate	up to 30 days	Readmission
Operation time	up to 30 days	Skin incision to wound closure
Hospital duration	up to 30 days	Hospital duration after surgery
Resection margin status	up to 30 days	According to the pathology report
Mortality	up to 30 days	Death within 30 days after surgery

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of