UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of residual gastric emptying capacity after gastrectomy by 13C breath test
Acronym	Evaluation of residual gastric emptying capacity after gastrectomy
Scientific Title	Evaluation of residual gastric emptying capacity after gastrectomy by 13C breath test
Scientific Title:Acronym	Evaluation of residual gastric emptying capacity after gastrectomy
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the digestive and absorptive capacity of post-gastrectomy patients using a non-invasive test of 13C intake and expiratory collection and analysis.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of digestive and absorptive capacity by 13C breath test from preoperative to 1, 3, 6, and 12 months postoperatively
Key secondary outcomes	Assessment of postoperative nutritional status (blood test results, body weight, body fat and muscle mass measurements), recurrence-free survival, and overall survival

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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Disease group Disease name : gastric tumor (including esophagogastric junction tumor) Stage : Stage does not matter Gender : no limitation Age : 20 years or older (at the time of registration) 2. Healthy control group Gender : 10 males and 10 females each Age : 40-70 years (at the time of enrollment) Those who have obtained consent for participation in this study by signing a consent.
Key exclusion criteria	1. Disease group Patients with severe diabetes or metabolic disease. Those with gastric stenosis or intestinal obstruction. Those who have refused to participate in the study. Pregnant or lactating women. 2.Healthy control group Those with diabetes or serious underlying diseases Those with a history of stomach or intestinal surgery (excluding appendicitis and cholelithiasis). Those who have refused to participate in the study. Those who are pregnant or lactating.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Sachiko Middle name Last name Kaida
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Tsukinowa-cho, Otsu, Shiga, Japan
TEL	077-548-2238
Email	kaida@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Sachiko Middle name Last name Kaida
Organization	Shiga University of Medical Science
Division name	Department of Surgery
Zip code	520-2192
Address	Tsukinowa-cho, Otsu, Shiga, Japan
TEL	077-548-2238
Homepage URL
Email	kaida@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Surgery, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Department of Surgery, Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Surgery, Shiga University of Medical Science
Address	Tsukinowa-cho, Otsu, Shiga, Japan
Tel	077-548-2238
Email	hqsurge1@belle.shiga-med.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	滋賀医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 14 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	2020 Year 12 Month 10 Day
Date of IRB	2020 Year 12 Month 10 Day
Anticipated trial start date	2020 Year 12 Month 14 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry	2025 Year 12 Month 31 Day
Date trial data considered complete	2025 Year 12 Month 31 Day
Date analysis concluded	2025 Year 12 Month 31 Day

Other
Other related information	To evaluate the digestive and absorptive capacity of post-gastrectomy patients by non-invasive tests of 13C intake and expiratory collection and analysis.

Management information
Registered date	2020 Year 12 Month 14 Day
Last modified on	2022 Year 05 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048763