Open Versus Laparoscopic Left-sided Hepatectomy Trial
OLLEH
A Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Left-sided Hepatectomy
1 other identifier
interventional
122
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2017
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJanuary 4, 2017
January 1, 2017
2.9 years
November 30, 2016
January 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
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.
up to 30 days
Secondary Outcomes (9)
Postoperative complication
up to 30 days
Mortality
up to 30 days
Readmission rate
up to 30 days
Hospital duration
up to 30 days
Blood loss
up to 30 days
- +4 more secondary outcomes
Study Arms (2)
A (Open left-sided hepatectomy)
ACTIVE COMPARATOROpen 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
B (Laparoscopic left-sided hepatectomy)
EXPERIMENTALTrocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
Interventions
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
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ewha Womans University Mokdong Hospitallead
- Korea Cancer Center Hospitalcollaborator
- Seoul National University Boramae Hospitalcollaborator
- Eulji University Hospitalcollaborator
- Bucheon St. Mary's Hospitalcollaborator
- Gyeongsang National University Hospitalcollaborator
- Jeju National University Hospitalcollaborator
- The Catholic University of Koreacollaborator
- Soonchunhyang University Hospitalcollaborator
- Inje Universitycollaborator
- Pusan National University Hospitalcollaborator
- DongGuk Universitycollaborator
- Chung-Ang University Hosptial, Chung-Ang University College of Medicinecollaborator
- Chonnam National University Hospitalcollaborator
- Hallym University Kangnam Sacred Heart Hospitalcollaborator
- Hallym University Medical Centercollaborator
- Seoul St. Mary's Hospitalcollaborator
Study Sites (1)
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 30, 2016
First Posted
January 4, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2021
Last Updated
January 4, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share