UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055884 |
|---|---|
| Receipt number | R000063784 |
| Scientific Title | A multi-center retrospective study on the occurrence risk of remnant gastric cancer based on the evaluation of the gastric mucosa and residual gastritis morphology after gastrectomy |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2025/04/21 09:55:14 |
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Basic information
Public title
A multi-center retrospective study on the occurrence risk of remnant gastric cancer based on the evaluation of the gastric mucosa and residual gastritis morphology after gastrectomy
Acronym
Remnant gastritis classification for predicting remnant gastric cancer
Scientific Title
A multi-center retrospective study on the occurrence risk of remnant gastric cancer based on the evaluation of the gastric mucosa and residual gastritis morphology after gastrectomy
Scientific Title:Acronym
Remnant gastritis classification for predicting remnant gastric cancer
Region
| Japan |
Condition
Condition
Gastric Cancer, Remnant Gastric CancerGastric Cancer, Remnant Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal remnant gastric cancer risk factor in respect to background remnant gastritis.
Basic objectives2
Others
Basic objectives -Others
To create a risk score for the occurrence of residual gastric cancer from the background gastric mucosa and the morphology of residual gastritis after gastrectomy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To reveal the relationship between the occurrence of remnant gastric cancer and the endoscopic findings of background remnant gastritis
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent gastrectomy or endoscopic submucosal dissection (ESD) for residual gastric cancer at our hospital or facilities participating in this study between January 1, 2000 and December 31, 2020.
Key exclusion criteria
1. Women who are pregnant or may become pregnant.
2. Patients participating in clinical research with other invasions (including minor invasions) that are considered to be related to this study.
3. Patients judged to be inappropriate by the attending physician or research collaborator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kubota |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Department of Digestive Surgery
Zip code
602-8566
Address
465,Kajii-cho, Kawaramachi-hirokoji,Kamigyo-ku, Kyoto
TEL
075-251-5527
tkubot@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kubota |
Organization
University Hospital, Kyoto Prefectural University of Medicin
Division name
Department of Digestive Surgery
Zip code
602-8566
Address
65,Kajii-cho, Kawaramachi-hirokoji,Kamigyo-ku, Kyoto
TEL
075-251-5527
Homepage URL
tkubot@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
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
Institutional Review Board of Kyoto Prefectural University of Medicine
Address
465,Kajii-cho, Kawaramachi-hirokoji,Kamigyo-ku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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
近江八幡市立総合医療センター（滋賀県）、京都きづ川病院（京都府）、京都鞍馬口医療センター（京都府）、京都第一赤十字病院（京都府）、済生会京都府病院（京都府）、福知山市民病院（京都府）、舞鶴医療センター（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 30 | 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
108
Results
Among the anastomotic findings, anastomotic redness and red streaks were more frequent in the RGC group, whereas no significant differences were observed in enlarged folds and bile reflux. Among background gastric mucosal findings, disappearance of RAC and atrophy were significantly associated with RGC. Roux-en-Y reconstruction demonstrated lower rates of bile reflux and anastomotic findings compared with Billroth I/II. Bile reflux was strongly correlated with anastomotic findings.
Results date posted
| 2025 | Year | 04 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with RGC was 40 at the Kyoto Prefectural University of Medicine, 19 at the Japanese Red Cross Society Kyoto Daiichi Hospital, 10 at the JCHO Kyoto Kuramaguchi Medical Center, 9 at the Maizuru Medical Center, 8 at the Kyoto Saiseikai Hospital, 7 at the Fukuchiyama City Hospital, 6 at the North Medical Center Kyoto Prefectural University of Medicine, 5 at the Omihachiman Community Medical Center, and 4 at the Kyoto Kizugawa Hospital.
Patients without RGC (control) who underwent upper gastrointestinal endoscopy at the Kyoto Prefectural University of Medicine was 614.
Participant flow
100 patients were enrolled as the RGC (+) group after excluding eight patients with insufficient endoscopic observations.
Of the 614 patients without RGC, 23 were within one year of the initial DG, 25 had unknown initial DG data, and 16 had insufficient endoscopic observations. Finally, a total of 550 patients were enrolled in the RGC (-) group.
After matching, 96 patients were included in each group
Adverse events
None.
Outcome measures
Degree of anastomotic findings (anastomotic redness, red streaks, enlarged folds) and background mucosa findings (regular arrangement of collection venules [RAC], atrophy, and intestinal metaplasia)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 11 | Day |
Other
Other related information
Study period: From Jan 1, 2013 to Dec 31, 2020
Management information
Registered date
| 2024 | Year | 10 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063784
