Neoplasm, LiverPhase 3OLLEHNCT03010085
Open Versus Laparoscopic Left-sided Hepatectomy Trial
A Phase 3 study testing Open left-sided hepatectomy and Laparoscopic left-sided hepatectomy in people with Neoplasm, Liver, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoplasm, Liver
- What is being tested?
- Open left-sided hepatectomy and Laparoscopic left-sided hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Eastern Cooperative Oncology Group performance status: 0 or 1
- American society of anesthesiology class: I or II
- Informed consent
Who cannot join
- 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
Show all 9Show fewer
- Combined operation for extrahepatic disease
- Vulnerable population (mental retardation, pregnancy)
- Patient who participated in other clinical trial within 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ewha Womans University Mokdong Hospital
Seoul, 07985
Huisong Lee, MD, +82-2-2650-6153, huisong.lee@ewha.ac.kr
About this study
Official title: 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
Read the 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.
- Conditions
- Neoplasm, Liver
- Being tested
- Open left-sided hepatectomy, Laparoscopic left-sided hepatectomy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open left-sided hepatectomyProcedure or surgery
Also called Left-sided hepatectomy, Left lateral sectionectomy, 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
Laparoscopic left-sided hepatectomyProcedure or surgery
Also called Laparoscopic left lateral sectionectomy, Laparoscopic left hemihepatectomy
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
| Study group | Role | What they receive |
|---|---|---|
| A (Open left-sided hepatectomy) | Active comparator | 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 Receives: Procedure: Open left-sided hepatectomy |
| B (Laparoscopic left-sided hepatectomy) | Experimental | Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy Receives: Procedure: Laparoscopic left-sided hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
Checklist of functional recovery
- (Questionnaire) Do you want intravenous analgesics for postoperative pain ? (Yes, No)
- (Questionnaire) Do you have trouble to ambulate by oneself ? (Yes, No)
- (Questionnaire) Do you have trouble to digest solid meal ? (Yes, No)
- (Questionnaire) Do you want intravenous fluid to subside your thirsty ? (Yes, No)
- (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.
Measured: up to 30 days
Secondary outcomes (9)
Postoperative complication
Discharge summary
Measured: up to 30 days
Mortality
Death within 30 days after surgery
Measured: up to 30 days
Readmission rate
Readmission
Measured: up to 30 days
Hospital duration
Hospital duration after surgery
Measured: up to 30 days
Blood loss
Estimated blood loss on anesthesiology sheet
Measured: up to 30 days
Operation time
Skin incision to wound closure
Measured: up to 30 days
Resection margin status
According to the pathology report
Measured: up to 30 days
Liver function test
Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin
Measured: up to 30 days
Quality of life
questionnaire
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Cancer Center Hospital, Seoul National University Boramae Hospital, Eulji University Hospital, Bucheon St. Mary's Hospital, Gyeongsang National University Hospital, Jeju National University Hospital, The Catholic University of Korea, Soonchunhyang University Hospital, Inje University, Pusan National University Hospital, DongGuk University, Chung-Ang University Hospital, Chonnam National University Hospital, Hallym University Kangnam Sacred Heart Hospital, Hallym University Medical Center, Seoul St. Mary's Hospital
- Responsible party
- Principal investigator, Huisong Lee, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010085
- Sponsor's protocol ID
- OLLEH trial
- Acronym
- OLLEH
- Status last verified
- Jan 2017
- First submitted
- 30 Nov 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Left-sided Hepatectomy
- ClinicalTrials.gov ID
- NCT03010085
- Acronym / sponsor ID
- OLLEH / OLLEH trial
- Conditions
- Neoplasm, Liver
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Collaborators
- Korea Cancer Center Hospital, Seoul National University Boramae Hospital, Eulji University Hospital, Bucheon St. Mary's Hospital, Gyeongsang National University Hospital, Jeju National University Hospital, The Catholic University of Korea, Soonchunhyang University Hospital, Inje University, Pusan National University Hospital, DongGuk University, Chung-Ang University Hospital, Chonnam National University Hospital, Hallym University Kangnam Sacred Heart Hospital, Hallym University Medical Center, Seoul St. Mary's Hospital
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (Open left-sided hepatectomy) | Active comparator | Procedure: Open left-sided hepatectomyOpen 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) | Experimental | Procedure: Laparoscopic left-sided hepatectomyTrocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient who underwent open or laparoscopic left-sided hepatectomy for benign or malignant neoplasm of the liver
- Child-Pugh A without portal hypertension
- Age 18 to 80
- Eastern Cooperative Oncology Group performance status: 0 or 1
- American society of anesthesiology class: I or II
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open left-sided hepatectomyAlso: Left-sided hepatectomy, Left lateral sectionectomy, Left hemihepatectomyOpen 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 | Procedure or surgery | A (Open left-sided hepatectomy) |
| Laparoscopic left-sided hepatectomyAlso: Laparoscopic left lateral sectionectomy, Laparoscopic left hemihepatectomyTrocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy | Procedure or surgery | B (Laparoscopic left-sided hepatectomy) |
Primary outcome
Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
Time frame: 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.
9 secondary outcomes
Postoperative complication
Time frame: up to 30 days
Mortality
Time frame: up to 30 days
Readmission rate
Time frame: up to 30 days
Hospital duration
Time frame: up to 30 days
Blood loss
Time frame: up to 30 days
Operation time
Time frame: up to 30 days
Resection margin status
Time frame: up to 30 days
Liver function test
Time frame: up to 30 days
Quality of life
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Electronic case report formLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Neoplasm, Liver
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingObservational study
Observational Study Protocol: LIVER-R
Hepatobiliary Cancers
Enrolling by invitationPhase 3
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
Cancer, Renal Cell Carcinoma (RCC)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
Colorectal Cancer, Liver Metastasis Colon Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Open left-sided hepatectomy and Laparoscopic left-sided hepatectomy in people with Neoplasm, Liver, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Duk Lee, MD (+82-31-920-1709, mmcleemed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase) (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.