UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026262
Receipt No. 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 (Ver. 4)

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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
Email 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
Email atmasuda@med.kobe-u.ac.jp

Sponsor
Institute Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030056