Open Versus Laparoscopic Left-sided Hepatectomy Trial

Neoplasm, Liver Clinical Trial

— OLLEH  

Official title:

A Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Left-sided Hepatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03010085
• Other study ID #: OLLEH trial
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 30, 2016
• Last updated: January 2, 2017
• Start date: January 2017
• Est. completion date: December 2021

Study information

• Verified date: January 2017
• Source: Ewha Womans University Mokdong Hospital
• Contact: Seung Duk Lee, MD
• Phone: +82-31-920-1709
• Email: mmcleemed[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: National Cancer Center
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: December 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Neoplasm, Liver

Intervention

Procedure:
• 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
• Laparoscopic left-sided hepatectomy
Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (17)

Lead Sponsor

Collaborator

Ewha Womans University Mokdong Hospital

Bucheon St. Mary's Hospital, Chonnam National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, DongGuk University, Eulji University Hospital, Gyeongsang National University Hospital, Hallym University Kangnam Sacred Heart Hospital, Hallym University Medical Center, Inje University, Jeju National University Hospital, Korea Cancer Center Hospital, Pusan National University Hospital, Seoul National University Boramae Hospital, Seoul St. Mary's Hospital, Soonchunhyang University Hospital, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 30 days	No
Secondary	Postoperative complication	Discharge summary	up to 30 days	Yes
Secondary	Mortality	Death within 30 days after surgery	up to 30 days	Yes
Secondary	Readmission rate	Readmission	up to 30 days	No
Secondary	Hospital duration	Hospital duration after surgery	up to 30 days	No
Secondary	Blood loss	Estimated blood loss on anesthesiology sheet	up to 30 days	No
Secondary	Operation time	Skin incision to wound closure	up to 30 days	No
Secondary	Resection margin status	According to the pathology report	up to 30 days	No
Secondary	Liver function test	Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin	up to 30 days	No
Secondary	Quality of life	questionnaire	up to 30 days	No

External Links

•   Electronic case report form