UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052908 |
|---|---|
| Receipt number | R000060362 |
| Scientific Title | Laparoscopic Approach for suspected Gallbladder cancer in Yamaguchi pancreatic / biliary disease study group with risk score based on the 2ndly survey |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2023/11/26 21:51:38 |
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Basic information
Public title
Laparoscopic Approach for suspected Gallbladder cancer in Yamaguchi pancreatic / biliary disease study group with risk score based on the 2ndly survey
Acronym
LAGBY2
Scientific Title
Laparoscopic Approach for suspected Gallbladder cancer in Yamaguchi pancreatic / biliary disease study group with risk score based on the 2ndly survey
Scientific Title:Acronym
LAGBY2
Region
| Japan |
Condition
Condition
Suspected gallbladder cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the accuracy of preoperative imaging diagnosis for suspected gallbladder cancer prospectively, and develop a criteria for improving diagnostic accuracy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of gallbladder cancer diagnosis in preoperative imaging
Key secondary outcomes
The bile leakage caused by intraoperative perforation, Conversion to open surgery
Operation time, Blood loss, Complication,
Pathological findings,
Overall survival, Disease free survival(Gallbladder cancer)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with suspected gallbladder cancer who will undergo laparoscopic whole layer cholecystectomy or gallbladder bed dissection in accordance with the following criteria
1)no gender
2)age over 20 years old
3)Gallbladder lesion detected by preoperative imaging studies such as CT, MRI, US, EUS, and PET, as shown in the list below.
Elevated lesion over 10 mm in diameter
Increasing tumor size
Sessile lesion
Irregular wall thickness lesion mimicking cancer
Elevated lesion with dense enhancement
FDG PET-positive
4)Patients who are not allergic to iodinated contrast media
5)The patients who gained written consent by the patient's free will with sufficient understanding after receiving sufficient explanation for the participation of this study,
Key exclusion criteria
1) Preoperative prediction of difficult laparoscopic procedure, such as encasement in the cystic duct and/or the hepatoduodenal ligament
2) Patients judged unsuitable as research subjects
Target sample size
65
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
0836222264
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
7558505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2264
Homepage URL
yt790604@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi Pancreatic / Biliary Disease Study Group
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi Pancreatic / Biliary Disease Study Group
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
| 2023 | Year | 11 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will prospectively evaluate the accuracy of preoperative imaging diagnosis using CT, MRI, abdominal US, EUS, and PET-CT in patients scheduled for total biopsy surgery for suspected gallbladder cancer, referring to imaging and pathological findings obtained in the previous LAGBY study, and attempt to establish criteria to improve diagnostic accuracy.
Management information
Registered date
| 2023 | Year | 11 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060362
