UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014511 |
|---|---|
| Receipt number | 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 19:29:16 |
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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
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
contact@keio-hbpts.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016817
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