UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042500 |
|---|---|
| Receipt number | R000048513 |
| Scientific Title | An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy: a prospective observational study |
| Date of disclosure of the study information | 2020/11/19 |
| Last modified on | 2020/11/19 15:00:34 |
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Basic information
Public title
An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy: a prospective observational study
Acronym
An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy
Scientific Title
An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy: a prospective observational study
Scientific Title:Acronym
An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
periampullary tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe our pancreaticogastrostomy technique following subtotal stomach-preserving pancreaticoduodenectomy and evaluate the perioperative outcomes with a focus on the incidence of postoperative pancreatic fistula and delayed gastric emptying.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Clinical relevant pancreatic fistula, delayed gastric emptying, and postoperative complications
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 43 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy
Key exclusion criteria
Laparoscopic pancreaticoduodenectomy, pancreaticoduodenectomy, pancreaticojejunostomy
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Teruo |
| Middle name | |
| Last name | Komokata |
Organization
National Hospital Organization Kagoshima Medical Center
Division name
Surgery
Zip code
892-0853
Address
8-1 Shiroyama-cho, Kagoshima-city
TEL
099-223-1151
komokata.teruo.je@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Teruo |
| Middle name | |
| Last name | Komokata |
Organization
National Hospital Organization Kagoshima Medical Center
Division name
Surgery
Zip code
892-0853
Address
8-1 Shiroyama-cho, Kagoshima-city
TEL
099-223-1151
Homepage URL
komokata.teruo.je@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kagoshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kagoshima Medical Center
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
National Hospital Organization Kagoshima Medical Center
Address
8-1 Shiroyama-cho, Kagoshima-city
Tel
099-223-1151
komokata.teruo.je@mail.hosp.go.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 | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
72
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 | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 11 | Month | 19 | Day |
Last modified on
| 2020 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048513
