UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056625 |
|---|---|
| Receipt number | R000064718 |
| Scientific Title | Three-sided mattress pancreaticojejunostomy in pancreatoduodenectomy: A Single-arm Pilot Study |
| Date of disclosure of the study information | 2025/01/04 |
| Last modified on | 2025/07/06 09:05:12 |
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Basic information
Public title
Three-sided mattress pancreaticojejunostomy in pancreatoduodenectomy: A Single-arm Pilot Study
Acronym
Three-sided mattress pancreaticojejunostomy in pancreatoduodenectomy: A Single-arm Pilot Study
Scientific Title
Three-sided mattress pancreaticojejunostomy in pancreatoduodenectomy: A Single-arm Pilot Study
Scientific Title:Acronym
Three-sided mattress pancreaticojejunostomy in pancreatoduodenectomy: A Single-arm Pilot Study
Region
| Japan |
Condition
Condition
Diseases in the pancreatic head region
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and usefulness of a "three-sided mattress suture method" in which mattress sutures are added to the superior and inferior sides of the pancreaticojejunostomy site after the modified Blumgart method in pancreaticojejunostomy following pancreaticoduodenectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of postoperative pancreatic fistula (ISGPF; GradeB or C)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients judged to have soft pancreas among those scheduled for pancreaticoduodenectomy.
2) The diameter of the main pancreatic duct at the planned pancreatic resection site is 5 mm or less on preoperative CT images.
3) ECOG-PS is 0-1.
4) Age 18 years or older.
5) The functions of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) are maintained.
6) Sufficient judgment to understand the content of the research and providing written informed consent.
Key exclusion criteria
1) Serious ischemic heart disease.
2) Complication of liver cirrhosis or active hepatitis.
3) Dyspnea requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis.
4) Undergoing dialysis for chronic renal failure.
5) Requiring combined resection of surrounding organs.
6) Considered to require arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc.
7) Active double cancers that may affect adverse events or overall survival.
8) Long-term oral steroid use that may cause adverse events.
9) Psychosis or psychiatric symptoms judged to potentially cause difficulty in participation in the study.
10) Any other person who the principal investigator or researcher deems inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Okada |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
TEL
0463931121
kokada@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Ei |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
2591193
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
TEL
0463931121
Homepage URL
ei.shigenori.h@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Research Ethics Committee, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
Tel
0463931121
tokai-rec@tokai.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
| 2025 | Year | 01 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not particular
Management information
Registered date
| 2025 | Year | 01 | Month | 04 | Day |
Last modified on
| 2025 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064718
