UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021345
Receipt No. R000024614
Scientific Title EUS imaging of background pancreas in patients with IPMN
Date of disclosure of the study information 2016/03/04
Last modified on 2018/03/08

* 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 EUS imaging of background pancreas in patients with IPMN
Acronym EUS image of background pancreas in IPMN
Scientific Title EUS imaging of background pancreas in patients with IPMN
Scientific Title:Acronym EUS image of background pancreas in IPMN
Region
Japan

Condition
Condition intraductal papillary mucnous neoplasm
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The recent guideline for intraductal papillary mucinous neoplasms (IPMNs) focuses on morphological features of the lesion as signs of malignant transformation, but ignores the background pancreatic parenchyma, including features of chronic pancreatitis, a risk factor for pancreatic malignancies. Endoscopic ultrasonography frequently reveals evidence of chronic pancreatitis (EUS-CP findings) in the background pancreatic parenchyma of patients with IPMNs. Therefore, we investigated whether background EUS-CP findings were associated with malignant IPMN.
Basic objectives2 Others
Basic objectives -Others Association of EUS-CP findings(chronic pancreatitis like change detected by EUS) with invasive IPMC
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Association of EUS-CP findings(chronic pancreatitis like change detected by EUS) with invasive IPMC
Key secondary outcomes 2. Association of EUS-CP findings with pathological changes of the pancreatic parenchyma
3. Association of pathological changes in the pancreatic parenchyma with malignant 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
90 years-old >
Gender Male and Female
Key inclusion criteria 69 consecutive patients with IPMNs in whom EUS was performed before surgical resection at Kobe University Hospital from April 2010 to October 2014
Key exclusion criteria Patients with concomitant pancreatic carcinoma (defined by the presence of two discrete tumors)
Target sample size 69

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Masuda
Organization Kobe University Graduate School of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-6305
Email atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamoru Takaenaka
Organization Kobe University Graduate School of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-6305
Homepage URL http://www.med.kobe-u.ac.jp/gi/ushiroall.html
Email mamox@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 JSPS KAKENHI, Research Committee of Intractable Pancreatic Diseases from the Ministry of Health, Labour, and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 03 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 Main results already published
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 04 Month 01 Day
Date analysis concluded
2016 Year 04 Month 02 Day

Other
Other related information Clinical data were collected for 69 consecutive patients with IPMNs in whom EUS was performed before surgical resection at Kobe University Hospital from April 2010 to October 2014. Patients with concomitant pancreatic carcinoma (defined by the presence of two discrete tumors) were excluded. We investigated various clinical and tumor characteristics, including the age, sex, abdominal symptoms (presence vs. absence), serum CEA (< 5 ng/ml vs. more than 5 ng/ml), serum CA19-9 (< 37 U/ml vs. more than 37 U/ml), diabetes mellitus (presence vs. absence), habitual drinking (none/sometimes/daily), alcohol consumption (< 50 g/day vs. more than 50 g/day), macroscopic type of IPMN (main duct, mixed, or branch duct type), cyst location (head vs. body/tail), main pancreatic duct diameter (<5 mm, 5-10 mm, >10 mm), mural nodule in the cyst (presence vs. absence), cyst diameter (<30 mm, 30-40 mm, > 40 mm), and tumor mucin phenotype (intestinal, gastric, pancreatobiliary, or oncocytic).

Management information
Registered date
2016 Year 03 Month 04 Day
Last modified on
2018 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.