UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Usefulness of Laparoscopic Surgery for Gallbladder carcinoma
Title of the study (Brief title)	The Usefulness of Laparoscopic Surgery for Gallbladder carcinoma
Region	Japan

Condition
Condition	Gallbladder carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the advantages of laparoscopic surgery over open surgery for gallbladder carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoperative blood loss
Key secondary outcomes	Intraoperative time, incidence of conversion to open surgery, postoperative hospital stay, intraoperative accident, postoperative complications, other general morbidities

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	The clinical outcomes were analyzed and compared between the laparoscopic and the open approach to gallbladder carcinoma.
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 preoperatively diagnosed with gallbladder carcinoma that need gallbladder bed resection, lymphadenectomy of the hepatoduodenal ligament, and biliary reconstruction according to the depth of tumor invasion. 2) Patients with the ECOG Performance Status 0 or 1. 3) Patients who have good liver function according to the results of the Child-Pugh classification and the ICG-R15 test (within 30 days before the registration), and are confirmed to withstand surgical operation by the principal investigator or the sub-investigators. 4) Patients with T2 or part of T3 gallbladder carcinoma, which means that direct invasion of tumor to liver is within 5mm (Hinf 0-1b). 5) Patients with no evidence of peritoneal dissemination, para-aortic lymph node metastasis, or invasion to the hepatoduodenal ligament in preoperative assessment. 6) Patients with sufficient function of important organs within 30 days before the registration: WBC; more than 3,000 /mm3, Neutrophils; more than 1,500 /mm3, serum Creatinine; more than twice the upper limit of normal range. 7) Patients with age over 20 years old at the time of informed consent. 8) Patients who confirmed the written informed consent.
Key exclusion criteria	1) Patients with evident peritoneal dissemination, invasion to the hepatoduodenal ligament, or para-aortic lymph node metastasis in preoperative assessment. 2) Patients with uncontrollable extrahepatic lesions. 3) Patients with symptomatic metastasis to brain. 4) Patients with symptomatic heart disease or under treatment of heart disease, or with history of myocardial infarction within a year before the registration. 5) Patients with double cancer or history of other malignancy within 5 years after the curative treatment, except for early stage carcinoma that would be completely cured by treatment. 6) Patients with interstitial pneumonia or pulmonary fibrosis. 7) Patients with severe infectious disease. 8) Patients with severe co-existing disease such as renal failure, liver failure, or uncontrollable hypertension. 9) Patients with grade 1-5 peripheral motor neuropathy of peripheral sensory neuropathy according to the CTCAE v4.0 - JCOG. 10) Patients with no intention of contraception, or during pregnancy or the lactation period. 11) Patients with history of severe anaphylaxis. 12) Patients who were diagnosed inadequacy for this study by the principal investigator or the sub-investigators.
Target sample size	10

Research contact person
Name of lead principal investigator	Osamu Itano
Organization	Department of surgery, Keio University, school of medicine
Division name	General surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	contact@keio-hbpts.jp

Public contact
Name of contact person	Hiroshi Yagi
Organization	Department of surgery, Keio University, school of medicine
Division name	General surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	contact@keio-hbpts.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 08 Day
Last modified on	2017 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016817