UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033977 |
|---|---|
| Receipt number | 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 19:17:42 |
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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
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
stakano@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038684
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
