UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042389 |
|---|---|
| Receipt number | 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 | 2021/11/15 15:40:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shinji-H@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
10
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
| 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 | 05 | Month | 11 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.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 |
