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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033977
Receipt No. R000038684
Scientific Title Ischemic gastropathy after distal pancreatectomy with en bloc celiac axis resection vs. distal pancreatectomy for pancreatic body/tail cancer: A prospective study
Date of disclosure of the study information 2018/08/31
Last modified on 2018/08/31

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Basic information
Public title Ischemic gastropathy after distal pancreatectomy with en bloc celiac axis resection vs. distal pancreatectomy for pancreatic body/tail cancer: A prospective study
Acronym The comparative analysis of ischemic gastropathy after DP-CAR vs. DP
Scientific Title Ischemic gastropathy after distal pancreatectomy with en bloc celiac axis resection vs. distal pancreatectomy for pancreatic body/tail cancer: A prospective study
Scientific Title:Acronym The comparative analysis of ischemic gastropathy after DP-CAR vs. DP
Region
Japan

Condition
Condition pancreatic body/tail cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim is to evaluate the stomach condition using endoscopy, a questionnaire, and the measurement for the blood flow of the stomach intraoperatively during pancreatiecomy for pancreatic body/tail cancer, and to elucidate the mechanism of ischemic gastropathy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the gastric blood flow before and after resection of the major arteries, the HyperEye Medical System is applied to visualize indocyanine green-enhanced structures with vivid color.
Key secondary outcomes Gastrointestinal endoscopy is performed before and a week after the operation to assess the patients' stomach condition.
Gastrointestinal Quality of Life Index is used as a scoring system to assess health-related quality of life in clinical studies of patients.

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

Not applicable
Gender Male and Female
Key inclusion criteria pancreatic body/tail cancer
Key exclusion criteria After gastrectomy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigetsugu Takano
Organization Graduate School of Medicine, Chiba University
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-226-2103
Email stakano@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigetsugu Takano
Organization Graduate School of Medicine, Chiba University
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-226-2103
Homepage URL
Email stakano@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization None
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
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 千葉大学医学部附属病院/Chiba University Hospital

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 31 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
The ICG-HEMS imaging system demonstrated more delayed arterial flow velocity in the ischemic gastropathy (IG) (+) group, but showed no significant differences in arterial flow volume compared to the IG (-) group.
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 Completed
Date of protocol fixation
2014 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 18 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information Despite no significant differences in the GIQLI score and intraoperative measurement of gastric arterial flow volume between the IG (+) and IG (-) groups, a high incidence rate of IG was observed using endoscopic examination. We should be aware that there are silent IG patients without any typical symptoms.

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2018 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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