UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061062 |
|---|---|
| Receipt number | R000069786 |
| Scientific Title | Contribution of RGA preserving PPPD for reducing complication rate of duodenojejunostomy compared to RGA transecting PPPD: A randomized controlled trial |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/26 06:40:39 |
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Basic information
Public title
Contribution of RGA preserving PPPD for reducing complication rate of duodenojejunostomy compared to RGA transecting PPPD: A randomized controlled trial
Acronym
Contribution of RGA preserving PPPD for reducing complication rate of duodenojejunostomy compared to RGA transecting PPPD: A randomized controlled trial
Scientific Title
Contribution of RGA preserving PPPD for reducing complication rate of duodenojejunostomy compared to RGA transecting PPPD: A randomized controlled trial
Scientific Title:Acronym
Contribution of RGA preserving PPPD for reducing complication rate of duodenojejunostomy compared to RGA transecting PPPD: A randomized controlled trial
Region
| Japan |
Condition
Condition
Patients with HPB/duodenal diseases requiring PPPD
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the significance of RGA preserving PPPD for reducing complication rate of duodenojejunostomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the significance of RGA preserving PPPD for reducing complication rate of duodenojejunostomy
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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Preservation of RGA
Interventions/Control_2
Transection of RGA
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Patients requiring PPPD due to HPB/duodenal diseases
2 Age over 18 years old
3 Obtaining written informed consent
Key exclusion criteria
1 Prior chemotherapy and/or radiotherapy, conversion case
2 Bulky LN metastasis at baseline
3 Requiring vessel reconstruction
4 Any patinets judged as insuitable for enrollment
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | Medical |
| Last name | Umemura |
Organization
School of Medicine, Iwate Medical University
Division name
Department of Surgery
Zip code
028-3695
Address
2-1-1, Idaidori, Yahaba, Shiwa-gun, Iwate
TEL
0196137111
auau001@hotmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | Medical |
| Last name | Umemura |
Organization
School of Medicine, Iwate Medical University
Division name
Department of Surgery
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba, Shiwa-gun, Iwate
TEL
0196137111
Homepage URL
aumemura@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Umemura Akira
Funding Source
Organization
Iwate Medical University
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
Iwate Medical Univerisity
Address
2-1-1 Idaidori, Yahaba, Shiwa-gun, Iwate
Tel
0196137111
aumemura@iwate-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 26 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069786
