UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026262 |
|---|---|
| Receipt number | R000030056 |
| Scientific Title | Location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm(IPMN) |
| Date of disclosure of the study information | 2017/02/22 |
| Last modified on | 2020/06/08 17:03:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm(IPMN)
Acronym
Cyst location and pancreatic cancer with IPMN
Scientific Title
Location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm(IPMN)
Scientific Title:Acronym
Cyst location and pancreatic cancer with IPMN
Region
| Japan |
Condition
Condition
intraductal papillary mucnous neoplasm
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Cancer-specific survival of PDAC with IPMN was significantly poorer compared with invasive IPMN. However, there was no description of the risk factors of PDAC concomitant with IPMN in The recent guideline for IPMNs. Therefore, we investigated the association of the location of cysts with the incidence of PDAC concomitant with IPMN.
Basic objectives2
Others
Basic objectives -Others
The relationship between location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with IPMN
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between location of cystic lesion and the Incidence of Pancreatic Cancer Concomitant with IPMN
Key secondary outcomes
The relationship between family history of pancreatic cancer, diabetes mellitus, alcohol consumption, BMI and smoking history, and the incidence of IPMN with an associated invasive carcinoma or pancreatic cancer concomitant with IPMN
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
more than 20 years old
Key exclusion criteria
None
Target sample size
164
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Masuda |
Organization
Kobe University Hospital
Division name
Dep. of Gastroenterology
Zip code
6500017
Address
7-5-1 Kusunoki-cho Chuo-ku Kobe
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Masuda |
Organization
Kobe University Hospital
Division name
Dep. of Gastroenterology
Zip code
6500017
Address
7-5-1 Kusunoki-cho Chuo-ku Kobe
TEL
078-382-6305
Homepage URL
atmasuda@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
CTRC
Address
7-5-1, Kusunoki-cho, Kobe
Tel
078-382-6669
rinri@med.kobe-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
| 2017 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.med.kobe-u.ac.jp/gi/pdf/study/ipmn-mrcp.pdf
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29685673/?from_term=ikagawa+takuya&from_exact_term=ikegawa+takuya&fr
Number of participants that the trial has enrolled
141
Results
Multiple cyst-existing regions (two or more regions) correlated with the incidence of PDAC concomitant with IPMN (PDAC concomitant with IPMN in one region vs. two or more regions: 3/66 vs. 13/75, multivariable odds ratio [OR] = 4.11, 95% confidence interval [CI] = 1.22 to 18.8, P = 0.02). In contrast, multiple cyst-existing regions did not correlate with the incidence of IPMN (invasive IPMN in one region vs. two or more regions: 13/66 vs. 18/75, OR = 1.19, 95% CI = 0.52 to 2.76, P = 0.67).
Results date posted
| 2020 | Year | 06 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects comprised 141 patients undergoing resection for IPMN (Non-invasive IPMN (IPMN with low-to high-grade dysplasia): N = 94, invasive IPMN: N = 31, and PDAC concomitant with IPMN: N = 16) between November 2000 and February 2017.
Participant flow
Subjects comprised 141 patients undergoing resection for IPMN (Non-invasive IPMN (IPMN with low-to high-grade dysplasia): N = 94, invasive IPMN: N = 31, and PDAC concomitant with IPMN: N = 16) between November 2000 and February 2017.
Adverse events
none
Outcome measures
A logistic regression analysis was performed to assess the relationship between the number of cyst-existing regions (one region/two or more regions) and incidence of PDAC concomitant with IPMN, adjusted by clinical characteristics. Cyst-existing regions were defined by the number of anatomical parts of the pancreas: the head/body/tail of the pancreas.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
retrospective study
164 consecutive patients of IPMN (N=142) or PDAC concomitant with IPMN (N=22) who underwent surgical resection at Kobe University Hospital between April 2008 and February 2017 were collected.
Survey items
age, body mass index (BMI), sex, diabetes mellitus (present or absent), family history of pancreatic cancer (present or absent), alcohol consumption (> 50 g/day or < 50 g/day), history of smoking, macroscopic type of IPMN (main duct type, mixed type, or branch duct type), mucin phenotype(gastric, intestinal, pancreatobiliary, or oncocytic), diameter of main pancreatic duct, nodule in cyst, diameter of cyst and location of cystic lesion.
Management information
Registered date
| 2017 | Year | 02 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030056
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
