UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058983 |
|---|---|
| Receipt number | R000067453 |
| Scientific Title | A Study on the Impact of Stent disfunction in Pancreatic Cancer Patients Undergoing Neo Adjuvant Chemotherapy (A Multicenter Retrospective Study) |
| Date of disclosure of the study information | 2025/09/04 |
| Last modified on | 2025/09/03 19:07:30 |
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Basic information
Public title
A Study on the Impact of Stent disfunction in Pancreatic Cancer Patients Undergoing Neo Adjuvant Chemotherapy (A Multicenter Retrospective Study)
Acronym
A Study on the Impact of Stent disfunction in Pancreatic Cancer Patients Undergoing Neo Adjuvant Chemotherapy (A Multicenter Retrospective Study)
Scientific Title
A Study on the Impact of Stent disfunction in Pancreatic Cancer Patients Undergoing Neo Adjuvant Chemotherapy (A Multicenter Retrospective Study)
Scientific Title:Acronym
A Study on the Impact of Stent disfunction in Pancreatic Cancer Patients Undergoing Neo Adjuvant Chemotherapy (A Multicenter Retrospective Study)
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively examined the impact of stent dysfunction on subsequent course, postoperative complications, and prognosis in patients with pancreatic cancer who underwent neoadjuvant chemotherapy with the intent of resection and who had a stent placed transpapillarly into the bile duct prior to initiating neoadjuvant chemotherapy.
Basic objectives2
Others
Basic objectives -Others
impact
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Feasibility of performing surgery
Changes in nutritional status
Association with perioperative complications
Association with post-ERCP pancreatitis
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients diagnosed with resectable (R) or borderline resectable (BR) pancreatic cancer based on abdominal CT images at initial presentation at our hospital or participating research institutions between January 1, 2019, and December 31, 2024.
(2)Patients who underwent transpapillary stent placement (plastic or metal stents) for the purpose of reducing jaundice, followed by the initiation of neoadjuvant chemotherapy.
(3)Patients who have undergone histological examination or cytological examination prior to registration but have not been diagnosed with neuroendocrine tumors (histological examination or cytological examination prior to registration is not mandatory)
(4)Patients aged 20 or older on the date of registration.
(5)Patients with appropriate organ function.
Key exclusion criteria
(1)Patients with unresectable pancreatic cancer.
(2)The patient has not undergone neoadjuvant chemotherapy.
(3)Patients with neuroendocrine tumors.
(4)Patients under 20 years of age.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hinokuchi |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
890-8520
Address
8-35-1 sakuragaoka , Kagoshima city, Kagoshima, Japan
TEL
099-275-5236
m.hinokuchi8013@gmail.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Hinokuchi |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
890-8520
Address
8-35-1 sakuragaoka , Kagoshima city, Kagoshima, Japan
TEL
099-275-5236
Homepage URL
m.hinokuchi8013@gmail.com
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University
Address
8-35-1 sakuragaoka , Kagoshima city, Kagoshima, Japan
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.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 | 09 | 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
139
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067453
