UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023751 |
|---|---|
| Receipt number | R000027370 |
| Scientific Title | A Randomized control trial: Pylorus-preserving Pancreatoduodenectomy VS Subtotal Stomach-preserving Pancreatoduodenectomy |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2025/03/01 10:31:27 |
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Basic information
Public title
A Randomized control trial: Pylorus-preserving Pancreatoduodenectomy VS Subtotal Stomach-preserving Pancreatoduodenectomy
Acronym
A Randomized control trial: PPPD VS SSPPD
Scientific Title
A Randomized control trial: Pylorus-preserving Pancreatoduodenectomy VS Subtotal Stomach-preserving Pancreatoduodenectomy
Scientific Title:Acronym
A Randomized control trial: PPPD VS SSPPD
Region
| Japan |
Condition
Condition
Patients to require pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of postoperative dylayed gastric emptying following Pylorus-Preserving Pancreatoduodenectomy and Subtotal Stomach-preserving Pancreatoduodenectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delayed gastric emptying
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PPPD group
Interventions/Control_2
SSPPD group
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients to require pancreaticoduodenectomy
Key exclusion criteria
1 patient to require gastrectomy
2 postgastrectomy
3 investigator not available
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | koji |
| Middle name | |
| Last name | Imai |
Organization
Asahikawa Medical University Hospital
Division name
Division of Gastrienterological and Transplant Surgery
Zip code
0788510
Address
2-1, Midorigaoka-Higashi, Asahikawa
TEL
0166-68-2503
kimai@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | koji |
| Middle name | |
| Last name | Imai |
Organization
Asahikawa Medical University Hospital
Division name
Division of Gastrienterological and Transplant Surgery
Zip code
0788510
Address
2-1, Midorigaoka-Higashi, Asahikawa
TEL
0166-68-2503
Homepage URL
kimai@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University
Address
2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido
Tel
0166682503
kimai@asahikawa-med.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
旭川医科大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
130
Results
The incidence of DGE was 5.4% in the PPPD group and 4.9% in the SSPPD group. There were no significant differences in preoperative and intraoperative factors such as operative time and blood loss, and no significant differences in postoperative weight change (after 1 month and 1 year), changes in nutritional status (serum albumin, prealbumin, musculoskeletal index), postoperative hospital stay, or postoperative survival in patients with malignant tumors.
Results date posted
| 2024 | Year | 10 | Month | 30 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
work in progress
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2016 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027370
