UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062051 |
|---|---|
| Receipt number | R000070998 |
| Scientific Title | Prospective observational exploratory study on the association between chewing behavior and symptoms and nutritional status after upper gastrointestinal resection |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/24 21:16:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective observational study of postoperative symptoms and nutritional status after upper gastrointestinal resection using a wearable chewing monitoring device
Acronym
Bitescan-UGI Study
Scientific Title
Prospective observational exploratory study on the association between chewing behavior and symptoms and nutritional status after upper gastrointestinal resection
Scientific Title:Acronym
Bitescan-UGI Study
Region
| Japan |
Condition
Condition
Gastric cancer, esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to exploratorily evaluate the association between chewing behavior measured using a wearable chewing monitoring device (bitescan) and postoperative symptoms, quality of life, body weight change, and nutritional status after upper gastrointestinal resection for gastric or esophageal cancer.
Basic objectives2
Others
Basic objectives -Others
To exploratorily evaluate the association between chewing behavior and postoperative symptoms, quality of life, body weight change, and nutritional status.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The total symptom score of the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45) at 3 months after surgery in the gastrectomy group.
Key secondary outcomes
Key secondary outcomes include dumping-related subscale scores, postoperative body weight loss rate, nutritional status, postoperative quality of life measures, dietary intake, the association between chewing behavior indices and skeletal muscle mass or body composition, and the association between chewing behavior indices and postoperative outcomes. In the esophagectomy group, quality of life measures including PGSAS-45, body weight loss rate, and nutritional status will be exploratorily evaluated. The association between oral function measures, including tongue pressure and maximum occlusal force, and chewing behavior indices will also be exploratorily assessed.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled to undergo elective gastrectomy for gastric cancer or related diseases, or elective esophagectomy for esophageal cancer.
2.Patients aged 18 years or older.
3.Patients who are able to take food orally, understand the study, and provide written informed consent.
Key exclusion criteria
1.Patients with severe dysphagia or those judged to be at high risk of aspiration and unable to safely consume the standardized test meal.
2.Patients with oral or temporomandibular joint disorders that may substantially affect chewing assessment.
3.Patients judged by the investigator to be inappropriate for participation in this study.
4.InBody body composition analysis will not be performed in patients with a pacemaker or implantable cardioverter-defibrillator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Kimura |
Organization
Kindai University Nara Hospital
Division name
Department of Gastroenterological Surgery
Zip code
630-0293
Address
1248-1 Ototacho, Ikoma, Nara 630-0293, Japan
TEL
0743-77-0880
agakuhara@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Gakuhara |
Organization
Kindai University Nara Hospital
Division name
Department of Gastroenterological Surgery
Zip code
630-0293
Address
1248-1 Ototacho, Ikoma, Nara 630-0293, Japan
TEL
0743-77-0880
Homepage URL
agakuhara@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Nara Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funded
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
Institutional Review Board of Kindai University Nara Hospital
Address
1248-1 Ototacho, Ikoma, Nara 630-0293, Japan
Tel
0743-77-0880
agakuhara@med.kindai.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
| 2026 | Year | 07 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study with no therapeutic intervention. Chewing behavior during consumption of a standardized test meal will be measured using a wearable chewing monitoring device (bitescan) before surgery and at 3 months after surgery. The association between chewing behavior and postoperative symptoms, quality of life, body weight change, and nutritional status will be exploratorily evaluated using questionnaires, body weight measurement, handgrip strength measurement, InBody body composition analysis, routinely obtained laboratory and CT data, and oral function tests.
Management information
Registered date
| 2026 | Year | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070998
