UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040758 |
|---|---|
| Receipt number | R000046539 |
| Scientific Title | A retrospective observational study to evaluate the efficacy of laparoscopic liver resection for small hepatocellular carcinoma located in the hepatic dome. |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2023/06/17 19:10:56 |
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Basic information
Public title
A retrospective observational study to evaluate the efficacy of laparoscopic liver resection for small hepatocellular carcinoma located in the hepatic dome.
Acronym
Laparoscopic liver resection for small hepatocellular carcinoma located in the hepatic dome.
Scientific Title
A retrospective observational study to evaluate the efficacy of laparoscopic liver resection for small hepatocellular carcinoma located in the hepatic dome.
Scientific Title:Acronym
Laparoscopic liver resection for small hepatocellular carcinoma located in the hepatic dome.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of laparoscopic liver resection for small hepatocellular carcinoma located in the hepatic dome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative hospital stay
Key secondary outcomes
Intraoperative blood loss, operation time
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hepatocellular carcinoma patients
who underwent open or laparoscopic radical resection in accordance with the following criteria
1) Any gender and age
2) Patients with solitary lesions of 5 cm or less, located in liver segments 2 to 6 where it is possible to perform partial hepatectomy and lateral segmentectomy, or Patients with solitary lesion of 3cm or less, located in segments 7 or 8 where it is possible to perform partial hepatectomy and subsegmentectomy.
3) The diagnoses of hepatocellular carcinoma were confirmed pathologically (including combined hepatocellular carcinoma and cholangiocellular carcinoma)
4) Hepatocellular carcinoma patients who underwent initial hepatectomy
Key exclusion criteria
1) Hepatocellular carcinoma patients who had undergone following treatments for the target lesion
-Percutaneous local ablative therapy (PEIT, RFA, MCT)
-Transarterial (chemo) embolization
-Radiation therapy
2) Hepatocellular carcinoma patients who underwent following procedure during the operation.
-Vascular resection and reconstruction.
-Tumor thrombectomy
-Biliary reconstruction
-Simultaneous resection of liver cancer and other internal organs, except the gallbladder
-Local ablative therapy (PEIT, RFA, MCT)
3) Multiple liver lesion
4) Thoracoscopic surgery
5) Robotic-assisted surgery
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Tokumitsu |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2264
Homepage URL
yt790604@yamaguchi-u.ac.jp
Sponsor or person
Institute
Kyusyu Study Group of Liver Surgery
Institute
Department
Personal name
Funding Source
Organization
Kyusyu Study Group of Liver Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-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 | 06 | Month | 15 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046539
Publication of results
Published
Result
URL related to results and publications
http://doi.org/10.1111/hepr.13929
Number of participants that the trial has enrolled
473
Results
After matching, 140 patients with LLR and 140 with OLR were analyzed. Significant differences were found between groups in terms of volume of blood loss (median, 55 vs. 287 ml, p < 0.001), postoperative complications (0.71 vs. 8.57%, p = 0.003), and postoperative hospital stay (median, 9 vs. 14 days, p < 0.001). The results of subgroup analysis of PS were similar. Short-term outcomes did not differ significantly between LLR-PS and LLR-AL after matching.
Results date posted
| 2023 | Year | 06 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent partial liver resection for single nodular HCCs within 3cm
Participant flow
In total, 473 patients who underwent partial liver resection for single nodular HCCs within 3 cm at the 18 institutions belonging to the Kyusyu Study Group of Liver Surgery from January 2010 to December 2018 were enrolled. The short-term outcomes of laparoscopic partial liver resection and open liver resection (OLR) for HCCs within 3 cm, with subgroup analysis of PS and AL, were compared using propensity score-matching analysis. Furthermore, results were also compared between LLR-PS and LLR-AL.
Adverse events
Not applicable
Outcome measures
Short-term results (Intraoperative blood loss, operation time, postoperative complications, length of postoperative hospital stay)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the fourth version of clinical practice guidelines for hepatocellular carcinoma by the Japan Society of Hepatology, laparoscopic hepatectomy was recommended for the Hepatocellular carcinoma patients with solitary lesions of 5 cm or less, located in liver segments 2 to 6 where it is possible to perform partial hepatectomy and lateral segmentectomy. In the current study, safety and efficacy of laparoscopic liver resection for small hepatocellular carcinoma located in the hepatic dome, which is considered to be beyond the recommended criteria, was investigated.
Management information
Registered date
| 2020 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046539
