UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039957 |
|---|---|
| Receipt number | R000045557 |
| Scientific Title | Multicenter prospective study of risk factors for conversion to laparotomy in patients undergoing laparoscopic liver resection. (HiSCO 08) |
| Date of disclosure of the study information | 2020/03/26 |
| Last modified on | 2025/03/30 11:23:41 |
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Basic information
Public title
Multicenter prospective study of risk factors for conversion to laparotomy in patients undergoing laparoscopic liver resection. (HiSCO 08)
Acronym
Multicenter prospective study of risk factors for conversion to laparotomy in patients undergoing laparoscopic liver resection. (HiSCO 08)
Scientific Title
Multicenter prospective study of risk factors for conversion to laparotomy in patients undergoing laparoscopic liver resection. (HiSCO 08)
Scientific Title:Acronym
Multicenter prospective study of risk factors for conversion to laparotomy in patients undergoing laparoscopic liver resection. (HiSCO 08)
Region
| Japan |
Condition
Condition
Liver tumor
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk factors for conversion to laparotomy in patients undergoing laparoscopic liver resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors for conversion to laparotomy
Key secondary outcomes
Operation time
Bleeding volume
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
liver resection
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Partial liver resection or left lateral segmentectomy for single liver tumor of 5 cm or less in the peripheral liver.
2. ECOG performance status of 0-1.
3. Written informed consent for laparoscopic liver resection.
Key exclusion criteria
1. Clinically significant allergy.
2. Clinically significant heart disease.
3. Clinically significant cirrhosis.
4. Clinically significant respiratory disease.
5. Clinically significant infection.
6. Anatomical liver resection other than left lateral segmentectomy.
7. Resection of other organs other than gallbladder. Gastrointestinal anastomosis. Biliary reconstruction. Lymph node dissection. Revascularization.
8. Patients whom doctors consider unsuitable.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ohdan |
Organization
Hiroshima University Hospital
Division name
Gasroenterological Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL
082-257-5222
jimukyoku@hisco-jpn.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Hiroshima University Hospital
Division name
Gasroenterological Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL
082-257-5222
Homepage URL
http://www.hisco-jpn.com/index.html
tsukoba@hiroshima-u.ac.jp
Sponsor or person
Institute
Gasroenterological Surgery, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN
Tel
082-257-5907
iryo-seisaku@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
199
Results
Of the 199 patients analyzed, 172 underwent pure LLR, while 27 required conversion. Conversion was significantly associated with male sex and three or more liver resections. The conversion rate increased from 2.5% for initial resections to 50.0% for the third or subsequent resections. Conversion resulted in a significantly longer operative time, increased blood loss, and prolonged hospital stay compared to pure LLR. Major postoperative complications did not differ significantly between the groups.
Results date posted
| 2025 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included patients aged 20 years or older who underwent wedge resection or left lateral segmentectomy for solitary liver tumors <5 cm in size, located away from major vessels. Patients requiring biliary duct reconstruction, revascularization, or simultaneous multi-organ resection were excluded.
Participant flow
Adverse events
none.
Outcome measures
The primary outcome was the identification of risk factors for conversion. Secondary outcomes were operative time, blood loss, postoperative complications, and length of hospital stay. Conversion was defined as a procedure requiring a switch to hand-assisted laparoscopic surgery (HALS) or OLR.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045557
