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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035352
Receipt No. R000040278
Scientific Title Laparoscopic Approaches for suspected Gallbladder cancer in Yamaguchi (LAGBY)
Date of disclosure of the study information 2018/12/25
Last modified on 2018/12/23

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Basic information
Public title Laparoscopic Approaches for suspected Gallbladder cancer in Yamaguchi (LAGBY)
Acronym Laparoscopic Approaches for suspected Gallbladder cancer in Yamaguchi (LAGBY)
Scientific Title Laparoscopic Approaches for suspected Gallbladder cancer in Yamaguchi (LAGBY)
Scientific Title:Acronym Laparoscopic Approaches for suspected Gallbladder cancer in Yamaguchi (LAGBY)
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 evaluate the safety of laparoscopic surgery as a total biopsy for suspected gallbladder cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The bile leakage caused by intraoperative perforation, Conversion to open surgery
Key secondary outcomes 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)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 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nagano
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL 0836-22-2264
Email hnagano@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Tokumitsu
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL 0836-22-2264
Homepage URL
Email yt790604@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi Pancreatic / Biliary Disease Study Group
Institute
Department

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
Address
Tel
Email

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
2018 Year 12 Month 25 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
2018 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Collecting information in daily practice of patients who undergo laparoscopic surgery for suspected Gallbladder cancer, and safety of this procedure will be evaluated.

Management information
Registered date
2018 Year 12 Month 23 Day
Last modified on
2018 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040278

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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