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Recruitment status Completed
Unique ID issued by UMIN UMIN000010864
Receipt No. R000012719
Scientific Title Evaluation of safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Date of disclosure of the study information 2013/07/01
Last modified on 2016/12/19

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Basic information
Public title Evaluation of safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Acronym Laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Scientific Title Evaluation of safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Scientific Title:Acronym Laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Region
Japan

Condition
Condition Neuroendocrine tumor
mucinous cystic neoplasm
serous cystic neoplasm
intraductal papillary mucinous neoplasm
Solid Pseudopapillary neoplasm
, etc.
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of laparoscopy-assisted pancreaticoduodenectomy for benign and low-grade malignant tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complication rate
Key secondary outcomes Conversion rate
Rate of postoperative pancreatic fistula
R0 resection rate
Postoperative hospital stay

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Laparoscopy-assisted pancreaticoduodenectomy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Benign and low-grade malignant tumor of the pancreatic head
2)ECOG Performance Status:0-1
3)BMI equal to or lower than 25
4)Major organ function is preserved and general anesthesia is possible
5)Signed informed consent
Key exclusion criteria 1)Patients diagnosed as pancreatic ductal carcinoma or suspected
2)Synchronous malignancyes
3)Emergency surgery
4)Acute or chronic pancreatitis
5)Acute cholangitis
6)Women during pregnancy
7)Patients possible to perform enucleation or partial resection
8)Patients judged as inadequate by investigators
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Morikawa
Organization Tohoku University Hospital
Division name Division of Hepato-Biliary Pancreatic surgery
Zip code
Address 1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Email t_morikawa@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Morikawa
Organization Tohoku University Hospital
Division name Division of Hepato-Biliary Pancreatic surgery
Zip code
Address 1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Homepage URL
Email t_morikawa@surg1.med.tohoku.ac.jp

Sponsor
Institute Division of Hepato-Biliary Pancreatic surgery, Tohoku University (Graduate School of Medicine)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Division of Hepato-Biliary Pancreatic surgery, Tohoku University (Graduate School of Medicine)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of gastrointestinal and pediatric surgery, Tokyo medical university
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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 01 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 03 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 07 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
2013 Year 06 Month 04 Day
Last modified on
2016 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012719


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