UMIN-CTR Clinical Trial

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
Email	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
Email	tminagawa@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052390