UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020070
Receipt number R000022904
Scientific Title Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy
Date of disclosure of the study information 2016/04/01
Last modified on 2022/06/09 09:18:11

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Basic information

Public title

Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy

Acronym

Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy

Scientific Title

Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy

Scientific Title:Acronym

Postoperative quality of life after gastrectomy for Stage I gastric cancer; a comparison analysis between total gastrectomy and proximal gastrectomy

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare postoperative quality of life between total gastrectomy and proximal gastrectomy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare postoperative body weight loss between total gastrectomy and proximal gastrectomy.

Key secondary outcomes

Scores of questionnaires;QLQ-C30, STO22 and PGSAS37, body composition, blood test, disease-free survival, overall survival and prevalence of remnant gastric cancer.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

Other

Interventions/Control_1

Total gastrectomy
Questionnaire
Perioperative

Interventions/Control_2

Proximal gastrectomy
Questionnaire
Perioperative

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) pathologically-confirmed gastric cancer (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, signet ring cell carcinoma and mucinous adenocarcinoma)
2) cStage IA or IB, but not T2 tumor at the greater curvature of the stomach
3) No indication of endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) in a cN0 or cN1case
4) Patients who underwent EMR or ESD and need additional surgery
5) No invasion of the esophagus
6) Aged 20 to 80 year
7) PS (ECOG) 0 or 1
8) No history of gastrointestinal surgery
9) No history of chemotherapy or radiotherapy
10) Capability of filling out a survey independently
11) Provided written informed consent

Key exclusion criteria

1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Simultaneous surgery other than cholecystectomy
3) Body mass index 30 or more
4) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name Kodera

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2111

Email

ykodera@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Mitsuro
Middle name
Last name Kanda

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2111

Homepage URL


Email

m-kanda@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

Nagoya University Ethics Review Committee

Address

65 Tsurumai-cho,Showa-ku,Nagoya

Tel

052-744-2479

Email

ethics@med.nagoya-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

2016 Year 04 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

110

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

No longer recruiting

Date of protocol fixation

2015 Year 12 Month 01 Day

Date of IRB

2015 Year 12 Month 01 Day

Anticipated trial start date

2016 Year 01 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study of postoperative quality of life after gastrectomy for Stage I gastric cancer, a comparison analysis between total gastrectomy and proximal gastrectomy using a questionnaire


Management information

Registered date

2015 Year 12 Month 04 Day

Last modified on

2022 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name