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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042389
Receipt No. R000048388
Scientific Title Phase 1 study evaluating the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy
Date of disclosure of the study information 2020/11/13
Last modified on 2020/11/09

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Basic information
Public title Phase 1 study evaluating the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy
Acronym Phase 1 study evaluating the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy
Scientific Title Phase 1 study evaluating the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy
Scientific Title:Acronym Phase 1 study evaluating the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy
Region
Japan

Condition
Condition Diseases requiring pancreaticoduodenectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examining the safety of a new pancreaticojejunostomy for pancreaticoduodenectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clavien-Dindo classification Grade 3b or higher (including the occurrence of pancreatic fistula of ISGPF Grade B or C)
Key secondary outcomes

Base
Study type Interventional

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 This is a simple technique of making two 8mm holes in the intestinal tract of the jejunal suture site, and covering the site with the pancreatic stump and placing a decompression tube in Roux Y jejunal limb.
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
85 years-old >
Gender Male and Female
Key inclusion criteria ASA-PS (American Society of Anesthesiologists physical status): 2 or less
Key exclusion criteria Patients with serious ischemic heart disease
Patients with cirrhosis of the liver (Child B or higher) or active hepatitis
Patients with dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis
Patients with chronic kidney failure on dialysis
Patients requiring complications of resection of other organs
BMI over 30.
Other cases deemed inappropriate by the doctor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Oda
Organization University of Tsukuba
Division name GI and HBP Surgery
Zip code 305-8575
Address 1-1-1, tennoudai,Tsukuba,Ibaraki
TEL 0298533221
Email tatoda@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Shinji
Middle name
Last name Hashimoto
Organization University of Tsukuba
Division name GI and HBP Surgery
Zip code 305-8575
Address 1-1-1, tennoudai,Tsukuba,Ibaraki
TEL 0298533221
Homepage URL
Email shinji-H@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Committee of University of Tsukuba Hospital
Address 2-1-1, amakubo,Tsukuba,Ibaraki
Tel 0298533914
Email t-credo.adm@un.tsukuba.ac.jp

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
2020 Year 11 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 05 Day
Date of IRB
2020 Year 11 Month 02 Day
Anticipated trial start date
2020 Year 11 Month 13 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 09 Day
Last modified on
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048388

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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