UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045961 |
|---|---|
| Receipt number | R000052462 |
| Scientific Title | Impact of gastrectomy for incurable advanced gastric cancer in the elderly |
| Date of disclosure of the study information | 2021/11/02 |
| Last modified on | 2021/11/09 15:40:20 |
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Basic information
Public title
Impact of gastrectomy for incurable advanced gastric cancer in the elderly
Acronym
Palliative gastrectomy in the elderly
Scientific Title
Impact of gastrectomy for incurable advanced gastric cancer in the elderly
Scientific Title:Acronym
Palliative gastrectomy in the elderly
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the significance of gastrectomy as a palliative surgery in elderly patients with incurable advanced gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival after surgery
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
| 80 | years-old | <= |
Age-upper limit
| 92 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We included 56 patients aged >80 years with incurable advanced gastric cancer who required surgical intervention at our department between February 1992 and July 2021. All patients were diagnosed with stage IV disease with at least one non-curative resection factor (non-resectable distant metastases, para-aortic lymph node metastasis above the celiac axis or below the inferior mesenteric artery or both, or non-resectable peritoneal carcinosis).
Key exclusion criteria
Twenty-six patients with gastric cancer of the upper part of the stomach, and three who underwent procedure other than gastrectomy or bypass (partial gastrectomy [n = 1] and gastrostomy [n = 2]) were excluded.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kusanagi |
Organization
Kameda Medical Center
Division name
Gastroenterological surgery
Zip code
296-0041
Address
929, Higashicho, Kamogawa, Chiba, Japan
TEL
04-7092-2211
kusanagi.hiroshi@kameda.jp
Public contact
Name of contact person
| 1st name | Goshi |
| Middle name | |
| Last name | Fujimoto |
Organization
Koga Community Hospital
Division name
Gastroenterological surgery
Zip code
425-0088
Address
2-30-1, Daikakuji, Yaizu, Shizuoka 425-0088, Japan
TEL
054-628-5500
Homepage URL
g_chimera_7@yahoo.co.jp
Sponsor or person
Institute
Kameda Medical Center
Gastroenterological surgery
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
Kameda Medical Center
Address
929, Higashicho, Kamogawa, Chiba, Japan
Tel
04-7092-2211
kusanagi.hiroshi@kameda.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
| 2021 | Year | 11 | Month | 02 | 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
56
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
Overall survival after surgery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We included 56 patients aged >80 years with incurable advanced gastric cancer who required surgical intervention at our department between February 1992 and July 2021. All patients were diagnosed with stage IV disease with at least one non-curative resection factor (non-resectable distant metastases, para-aortic lymph node metastasis above the celiac axis or below the inferior mesenteric artery or both, or non-resectable peritoneal carcinosis). Twenty-six patients with gastric cancer of the upper part of the stomach, and three who underwent procedure other than gastrectomy or bypass (partial gastrectomy [n = 1] and gastrostomy [n = 2]) were excluded. The patients' characteristics, surgical and pathological findings, and postoperative clinical courses were retrieved from medical records and databases at our institution.
Management information
Registered date
| 2021 | Year | 11 | Month | 02 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052462
