UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000044310
Receipt number	R000050588
Scientific Title	The prognosis after curative resection for stage IA gastric cancer in elderly patients: a comparison of endoscopic submucosal dissection and surgery
Date of disclosure of the study information	2021/05/24
Last modified on	2022/05/24 23:32:53

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Basic information

Public title

The prognosis of early gastric cancer in elderly patients after endoscopic resection and surgery

Acronym

The prognosis of early gastric cancer in elderly patients

Scientific Title

The prognosis after curative resection for stage IA gastric cancer in elderly patients: a comparison of endoscopic submucosal dissection and surgery

Scientific Title:Acronym

Elderly patients with stage IA gastric cancer

Region

Japan

Condition

Stage IA gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To determine whether gastrectomy is related to poor survival in elderly patients and to evaluate the effect of patient characteristics on the prognosis of early gastric cancer after curative resection with endoscopic submucosal dissection and surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Cause of death
Cancer recurrence
Procedure complication

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

75 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(i) Age: 75years or older
(ii) Primary EGC
(iii) Histologically diagnosed adenocarcinoma
(iv) Lesions resected with ESD that met the guidelines' criteria for curative resection or expanded-indication curative resection or lesions resected with surgery and had no pathological metastasis in the regional lymph node (categorized as stage IA)

Key exclusion criteria

(i) Additional gastrectomy after ESD
(ii) Follow-up period: less than 3 years
(iii) Missing data.

Target sample size

538

Research contact person

Name of lead principal investigator

1st name Koji

Middle name

Last name Miyahara

Organization

Hiroshima City Hiroshima Citizens Hospital

Division name

Internal Medicine

Zip code

730-8518

Address

7-33 Moto-machi, Naka-ku, Hiroshima

TEL

+81-82-221-2291

Email

mkojisup@yahoo.co.jp

Public contact

Name of contact person

1st name Koji

Middle name

Last name Miyahara

Organization

Hiroshima City Hiroshima Citizens Hospital

Division name

Internal Medicine

Zip code

730-8518

Address

7-33 Moto-machi, Naka-ku, Hiroshima

TEL

+81-82-221-2291

Homepage URL

Email

mkojisup@yahoo.co.jp

Sponsor or person

Institute

Hiroshima City Hiroshima Citizens Hospital

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

Hiroshima City Hiroshima Citizens Hospital Ethics Committee

Address

7-33 Moto-machi, Naka-ku, Hiroshima

Tel

+81-82-221-2291

Email

mkojisup@yahoo.co.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 24 Day

Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35089444/

Publication of results

Published

Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35089444/

Number of participants that the trial has enrolled

589

Results

We analyzed data on 365 patients who underwent ESD and 170 patients who underwent surgery. Overall survival(OS) was not significantly different for the ESD group vs. the surgery group (P = 0.506). Multivariate analysis revealed that treatments; namely, ESD or surgery, were not associated with OS. Similar results were observed even in the subgroups with worse conditions.

Results date posted

2022 Year 05 Month 24 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Retrospective study

Participant flow

Retrospective study

Adverse events

none

Outcome measures

Occurrence of any procedure-related complications.
Long-term outcomes, including cancer recurrence, overall survival, and causes of death.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 01 Month 23 Day

Date of IRB

2019 Year 02 Month 08 Day

Anticipated trial start date

2019 Year 02 Month 08 Day

Last follow-up date

2021 Year 01 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Retrospective observational study

Management information

Registered date

2021 Year 05 Month 24 Day

Last modified on

2022 Year 05 Month 24 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050588

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name