UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045929 |
|---|---|
| Receipt number | R000052390 |
| Scientific Title | Clinical implication of laparoscopic gallbladder bed resection for gallbladder cancer |
| Date of disclosure of the study information | 2021/10/30 |
| Last modified on | 2021/10/30 22:29:35 |
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Basic information
Public title
Clinical implication of laparoscopic surgery for gallbladder cancer
Acronym
Clinical implication of laparoscopic surgery for gallbladder cancer
Scientific Title
Clinical implication of laparoscopic gallbladder bed resection for gallbladder cancer
Scientific Title:Acronym
Clinical implication of laparoscopic gallbladder bed resection for gallbladder cancer
Region
| Japan |
Condition
Condition
Gallbladder cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy for laparoscopic gallbladder bed resection for suspected gallbladder cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic gallbladder bed 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) Patients with gallbladder cancer, including cases with suspicious preoperative diagnosis, who will undergo cholecystectomy with lymph node dissection and biliary tract reconstruction, depending on the extent of bile duct invasion.
2) Patients with a performance status of 0-1 who can tolerate surgery.
3) Patients who are judged by the principal investigator or sub-investigator to have sufficient liver function for surgery based on the results of Child-Pugh classification and ICG retention test (within 30 days prior to enrollment).
4) Patients with preoperatively diagnosed as T2 and part of T3 (direct intrahepatic invasion within 5 mm; Hinf1b or less).
5) Patients with no obvious peritoneal dissemination, paraaortic lymph node metastasis, or hepatoduodenal ligament invasion before surgery.
6) Patients must meet the following criteria for major organ function within 30 days prior to enrollment.
(a) Bone marrow function: White blood cell: >=3,000/mm3, Neutrophil: >=1,500/mm3
(b) Renal function: Serum creatinine: <= 2 times the upper limit of institutional normal (ULN)
7) Patient must be 20 years of age or older at the time of obtaining consent.
8) Explanations using a prescribed document must be given to the subject, and written consent must be obtained from the subject.
Key exclusion criteria
1) Patients with preoperative diagnosis of peritoneal dissemination, hepatoduodenal mesenteric infiltration, or paraaortic lymph node metastasis.
2) Patients with uncontrolled extrahepatic lesions.
3) Patients with symptomatic brain metastases.
4) Patients with cardiac disease who are symptomatic at the time of enrollment or are undergoing any treatment. Or, patients with past medical history of myocardial infarction within 1 year prior to enrollment.
5) Patients with concurrent multiple cancers or heterogeneous multiple cancers with disease-free period of less than 5 years. However, patients with early-stage cancer that can be expected to be cured by treatment can be enrolled.
6) Patients with severe interstitial pneumonia or pulmonary fibrosis.
7) Patients with serious infectious diseases.
8) Patients with serious complications (renal failure, liver failure, hypertension uncontrolled by drugs).
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Itano |
Organization
School of Medicine, International University of Health and Welfare
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
286-0124
Address
Hatakeda 852, Narita, Chiba
TEL
0476-35-5600
itano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Minagawa |
Organization
School of Medicine, International University of Health and Welfare
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
286-0124
Address
Hatakeda 852, Narita, Chiba
TEL
0476-35-5600
Homepage URL
tminagawa@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
Institutional review board, International University of Health and Welfare
Address
Hatakeda 852, Narita, Chiba
Tel
0476-35-5600
rinri_md@iuhw.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
| 2021 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2021 | Year | 10 | Month | 30 | Day |
Last modified on
| 2021 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052390
