UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014844 |
|---|---|
| Receipt number | R000017144 |
| Scientific Title | The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor |
| Date of disclosure of the study information | 2014/08/13 |
| Last modified on | 2017/10/14 19:39:05 |
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Basic information
Public title
The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor
Acronym
The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor
Scientific Title
The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor
Scientific Title:Acronym
The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor
Region
| Japan |
Condition
Condition
biliary tract tumor or pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The usefulness of staging laparoscopy for biliary tract tumor or pancreatic tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative blood loss
proper diagnosis rate
Key secondary outcomes
Efficacy: incidence of conversion to open surgery, postoperative hospital stay
Safety: intraoperative accident, postoperative complications, other general morbidities
Curability(case of malignancy): recurrence rate, patterns of recurrence, vital prognosis
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
Accurate diagnosis is made by staging laparoscopy for biliary tract or pancreatic tumor.
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)benign or low malignant potential tumor located in bililary tract or pancreas
2)pancreatic cancer, duodenum papilla cancer, extrahepatic bile duct cancer
3)ECOG Performance Status 0 or 1 or 2
4)sufficient function of important organs
WBC: >=2,000/mm3 and <=10,000/mm3
Platelet: >=50,000/mm3
Cr:=<twice upper limit of normal
5)written informed consent
Key exclusion criteria
1)patients who is judged that laparoscopy is dangerous
Target sample size
30
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
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
contact@keio-hpbts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kitago |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
contact@keio-hpbts.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
慶応義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | 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 | 08 | Month | 12 | 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=R000017144
