UMIN-CTR Clinical Trial

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
Email	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
Email	g_chimera_7@yahoo.co.jp

Sponsor
Institute	Kameda Medical Center Gastroenterological surgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052462