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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014511
Receipt No. R000016817
Scientific Title The Usefulness of Laparoscopic Surgery for Gallbladder carcinoma
Date of disclosure of the study information 2014/07/09
Last modified on 2017/10/14

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Basic information
Public title The Usefulness of Laparoscopic Surgery for Gallbladder carcinoma
Acronym The Usefulness of Laparoscopic Surgery for Gallbladder carcinoma
Scientific Title The Usefulness of Laparoscopic Surgery for Gallbladder carcinoma
Scientific Title:Acronym 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
1st name
Middle name
Last name Osamu Itano
Organization Department of surgery, Keio University, school of medicine
Division name General surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email contact@keio-hbpts.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Yagi
Organization Department of surgery, Keio University, school of medicine
Division name General surgery
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
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

Other
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

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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