UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011316 |
|---|---|
| Receipt number | R000013262 |
| Scientific Title | Laparoscopic (laparoscopy-assisted) pancreaticoduodenectomy |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2014/01/30 17:00:23 |
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Basic information
Public title
Laparoscopic (laparoscopy-assisted) pancreaticoduodenectomy
Acronym
Laparoscopic pancreaticoduodenectomy
Scientific Title
Laparoscopic (laparoscopy-assisted) pancreaticoduodenectomy
Scientific Title:Acronym
Laparoscopic pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
Periampullary tumor, chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safty and efficacy of laparoscopic (laparoscopy-assisted) pancreaticoduodenectomy for periampullary tumors and chronic pancreatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safty and efficacy
Key secondary outcomes
Surgical curability for tumors
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Periampullary tumors without lymph node metastasis and invasion of vessels such as portal vein, and limited chronic pancreatitis in the pancreatic head
Key exclusion criteria
1. Tumors with lymph node metastasis and invasion of portal vein and/or nerves around superior mesenteric artery
2. Bad general condition
3. Pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Ohta |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu, Oita 8795593, Japan
TEL
097-586-5843
ohta@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Ohta |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu, Oita 8795593, Japan
TEL
097-586-5843
Homepage URL
ohta@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oita University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
大分大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 30 | Day |
Last modified on
| 2014 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013262
