- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03010085
Open Versus Laparoscopic Left-sided Hepatectomy Trial (OLLEH)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Seung Duk Lee, MD
- Phone Number: +82-31-920-1709
- Email: mmcleemed@gmail.com
Study Contact Backup
- Name: Yunsung Seo, MS
- Phone Number: +82-31-920-0745
- Email: 73872@ncc.re.kr
Study Locations
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-
-
Seoul, Korea, Republic of, 07985
- Ewha Womans University Mokdong Hospital
-
Contact:
- Huisong Lee, MD
- Phone Number: +82-2-2650-6153
- Email: huisong.lee@ewha.ac.kr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient who underwent open or laparoscopic left-sided hepatectomy for benign or malignant neoplasm of the liver
Child-Pugh A without portal hypertension
- No portosystemic shunt
- No splenomegaly
- Platelet count >100,000/ul
- Age 18 to 80
- Eastern Cooperative Oncology Group performance status: 0 or 1
- American society of anesthesiology class: I or II
- Informed consent
Exclusion Criteria:
- Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
- Combined hepatectomy
- Bile duct reconstruction
- Intrahepatic duct stone
- Upper abdominal laparotomy history
- Previous hepatectomy
- Combined operation for extrahepatic disease
- Vulnerable population (mental retardation, pregnancy)
- Patient who participated in other clinical trial within 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A (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
|
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
Other Names:
|
Experimental: B (Laparoscopic left-sided hepatectomy)
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
|
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
Time Frame: up to 30 days
|
Checklist of functional recovery
|
up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complication
Time Frame: up to 30 days
|
Discharge summary
|
up to 30 days
|
Mortality
Time Frame: up to 30 days
|
Death within 30 days after surgery
|
up to 30 days
|
Readmission rate
Time Frame: up to 30 days
|
Readmission
|
up to 30 days
|
Hospital duration
Time Frame: up to 30 days
|
Hospital duration after surgery
|
up to 30 days
|
Blood loss
Time Frame: up to 30 days
|
Estimated blood loss on anesthesiology sheet
|
up to 30 days
|
Operation time
Time Frame: up to 30 days
|
Skin incision to wound closure
|
up to 30 days
|
Resection margin status
Time Frame: up to 30 days
|
According to the pathology report
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up to 30 days
|
Liver function test
Time Frame: up to 30 days
|
Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin
|
up to 30 days
|
Quality of life
Time Frame: up to 30 days
|
questionnaire
|
up to 30 days
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OLLEH trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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