UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053011 |
|---|---|
| Receipt number | R000060473 |
| Scientific Title | Study on the Safety of Gastric Subtotal Resection with Preservation of Ghrelin Secretory Area for Upper Gastric Cancer |
| Date of disclosure of the study information | 2023/12/06 |
| Last modified on | 2023/12/06 10:27:38 |
* 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
Study on the Safety of Gastric Subtotal Resection with Preservation of Ghrelin Secretory Area for Upper Gastric Cancer
Acronym
Study on the Safety of Gastric Subtotal Resection with Preservation of Ghrelin Secretory Area for Upper Gastric Cancer
Scientific Title
Study on the Safety of Gastric Subtotal Resection with Preservation of Ghrelin Secretory Area for Upper Gastric Cancer
Scientific Title:Acronym
Study on the Safety of Gastric Subtotal Resection with Preservation of Ghrelin Secretory Area for Upper Gastric Cancer
Region
| Japan |
Condition
Condition
Gastric cancer, esophagogastric junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to confirm the safety of subtotal gastrectomy for upper gastric cancer with preservation of the ghrelin-secreting region and the absence of ghrelin reduction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Novel technique emphasizing preservation of ghrelin secretion zone
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men and women from 20 to 85 years old
2) Lesions involving the upper part of the body of the stomach and the esophagogastric junction
3) Any histologic type, clinical stage up to cStgae II.
4) Preoperative chemotherapy or not.
5) Cases without comorbidities affecting gastrectomy.
6) Cases without organ failure or psychiatric disorders.
7) Have an understanding of and be willing to participate in this study.
Key exclusion criteria
1) Lesions over the upper body of the stomach and the greater curvature of the esophagogastric junction are excluded.
2) Cases with multiple, highly advanced malignancies.
3) Cases with co-surgery with other carcinomas.
4) Case of residual gastric cancer.
5) Cases in patients who do not give consent for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hiki |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0375
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
nhiki@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Higuchi |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0375
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
higuchi.tadashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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 in Kitasato University Hospital
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8111
rinrib@med.kitasato-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 | 12 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2034 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060473
