UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049944 |
|---|---|
| Receipt number | R000056506 |
| Scientific Title | Randomized Controlled Trial of preserving vs resecting residual stomach for Esophageal Cancer after Distal Gastrectomy |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/12/30 21:37:37 |
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Basic information
Public title
Randomized Controlled Trial of preserving vs resecting residual stomach for Esophageal Cancer after Distal Gastrectomy
Acronym
RCT of preserving vs resecting residual stomach for EC after DG
Scientific Title
Randomized Controlled Trial of preserving vs resecting residual stomach for Esophageal Cancer after Distal Gastrectomy
Scientific Title:Acronym
RCT of preserving vs resecting residual stomach for EC after DG
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of preserving vs resecting residual stomach in patients with esophageal cancer after Distal Gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight loss at 6 months after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
preserving residual stomach
Interventions/Control_2
resecting residual stomach
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
Esophageal cancer diagnosed as squamous cell carcinoma, adenosquamous carcinoma, carcinosarcoma, basaloid carcinoma, or adenocarcinoma on biopsy
Patients who have undergone distal gastrectomy (B-I reconstruction) for gastric cancer, gastric ulcer, duodenal ulcer, etc.
Patients who are judged to be eligible for sternal jejunum or sternal colon reconstruction in preoperative estimation.
Performance status 0-2 (ECOG classification)
Patients diagnosed as eligible for R0 resection
Patients with written consent to participate in this study
No previous surgery involving resection of jejunum
Patients with adequate bone marrow, liver, and renal function
Key exclusion criteria
Cases with preoperative examination showing non-curative factors such as dissemination, liver metastasis, distant metastasis, etc.
Cases of concurrent overlapping cancers
Heterochronic overlapping cancers that have recurred after treatment or have been untreated for more than 5 years, or are currently carcinoma-bearing other than gastric cancer.
Patients with poorly controlled diabetes mellitus (HbA1c: 8.0 or higher).
Patients deemed by the investigator to be inappropriate for the safe conduct of this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Osaka university
Division name
Department of Gastroenterological Surgery, Graduate School of Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City. Osaka
TEL
0668793251
gesurgmail@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka university
Division name
Department of Gastroenterological Surgery, Graduate School of Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City. Osaka
TEL
0668793251
Homepage URL
ktanaka@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka university
Address
2-2 Yamadaoka, Suita City. Osaka
Tel
0668793251
gesurgmail@gesurg.med.osaka-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
| 2023 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 30 | Day |
Last modified on
| 2022 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056506
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
