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Open Versus Laparoscopic Left-sided Hepatectomy Trial (OLLEH)

Primary Purpose

Neoplasm, Liver

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Open left-sided hepatectomy
Laparoscopic left-sided hepatectomy
Sponsored by
Ewha Womans University Mokdong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm, Liver

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A (Open left-sided hepatectomy)

B (Laparoscopic left-sided hepatectomy)

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative complication
Discharge summary
Mortality
Death within 30 days after surgery
Readmission rate
Readmission
Hospital duration
Hospital duration after surgery
Blood loss
Estimated blood loss on anesthesiology sheet
Operation time
Skin incision to wound closure
Resection margin status
According to the pathology report
Liver function test
Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin
Quality of life
questionnaire

Full Information

First Posted
November 30, 2016
Last Updated
January 2, 2017
Sponsor
Ewha Womans University Mokdong Hospital
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 Hosptial, Chung-Ang University College of Medicine, Chonnam National University Hospital, Hallym University Kangnam Sacred Heart Hospital, Hallym University Medical Center, Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03010085
Brief Title
Open Versus Laparoscopic Left-sided Hepatectomy Trial
Acronym
OLLEH
Official Title
A Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Left-sided Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University Mokdong Hospital
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 Hosptial, Chung-Ang University College of Medicine, Chonnam National University Hospital, Hallym University Kangnam Sacred Heart Hospital, Hallym University Medical Center, Seoul St. Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm, Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (Open left-sided hepatectomy)
Arm Type
Active Comparator
Arm 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
Arm Title
B (Laparoscopic left-sided hepatectomy)
Arm Type
Experimental
Arm Description
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
Intervention Type
Procedure
Intervention Name(s)
Open left-sided hepatectomy
Other Intervention Name(s)
Left-sided hepatectomy, Left lateral sectionectomy, Left hemihepatectomy
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic left-sided hepatectomy
Other Intervention Name(s)
Laparoscopic left lateral sectionectomy, Laparoscopic left hemihepatectomy
Intervention Description
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
Primary Outcome Measure Information:
Title
Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
Description
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.
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Postoperative complication
Description
Discharge summary
Time Frame
up to 30 days
Title
Mortality
Description
Death within 30 days after surgery
Time Frame
up to 30 days
Title
Readmission rate
Description
Readmission
Time Frame
up to 30 days
Title
Hospital duration
Description
Hospital duration after surgery
Time Frame
up to 30 days
Title
Blood loss
Description
Estimated blood loss on anesthesiology sheet
Time Frame
up to 30 days
Title
Operation time
Description
Skin incision to wound closure
Time Frame
up to 30 days
Title
Resection margin status
Description
According to the pathology report
Time Frame
up to 30 days
Title
Liver function test
Description
Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin
Time Frame
up to 30 days
Title
Quality of life
Description
questionnaire
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Duk Lee, MD
Phone
+82-31-920-1709
Email
mmcleemed@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yunsung Seo, MS
Phone
+82-31-920-0745
Email
73872@ncc.re.kr
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huisong Lee, MD
Phone
+82-2-2650-6153
Email
huisong.lee@ewha.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Open Versus Laparoscopic Left-sided Hepatectomy Trial

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