Unique ID issued by UMIN | UMIN000041142 |
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Receipt number | R000046428 |
Scientific Title | Prevalence of Behavioral Disorders in Patients with Vonoprazan-refractory Reflux Symptoms. |
Date of disclosure of the study information | 2020/07/17 |
Last modified on | 2022/07/19 11:41:17 |
Behavioral disorders in patients with reflux symptoms which are resistant to vonoprazan
Behavioral disorders in patients with reflux symptoms
Prevalence of Behavioral Disorders in Patients with Vonoprazan-refractory Reflux Symptoms.
Behavioral Disorders in GERD
Japan |
Gastroesophageal reflux disease
Gastroenterology |
Others
NO
To investigate the proportion of patients with supragastric belching and rumiantion syndrome in vonoprazan-refractory patients in Japan
Others
Prevalence
the proportion of patients with supragastric belching and rumiantion syndrome in vonoprazan-refractory patients
To investigate predictive factors of behavioral disorders.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
patients with VPZ-refractory reflux symptoms who were referred to our tertiary referral center in Tokyo, Japan between January 2015 and March 2020. The eligibility criteria were (i) 18 years or older; (ii) persistent reflux symptoms (heartburn or regurgitation) despite a 2-week treatment with 20 mg VPZ; (iii) never been diagnosed with reflux esophagitis; and (iv) adequate records of HRM, MIIpH on 20 mg VPZ, and EGD, which were performed within 6 months.
(i) patients diagnosed with endoscopic esophagitis
(ii) patients who had impedance-pH metry off vonoprazan 20mg
50
1st name | Yoshimasa |
Middle name | |
Last name | Hoshikawa |
Nippon Medical School
Department of Gastroenterology
113-8603
1-1-5 Sendagi Bunkyo-ku Tokyo, Japan
03-3822-2131
y-hoshikawa@nms.ac.jp
1st name | Yoshimasa |
Middle name | |
Last name | Hoshikawa |
Nippon Medical School
Department of Gastroenterology
113-8603
1-1-5 Sendagi Bunkyo-ku Tokyo, Japan
03-3822-2131
y-hoshikawa@nms.ac.jp
Nippon Medical School
Nippon Medical School
Other
Nippon Medical School Ethics Comittee
1-1-5 Sendagi Bunkyo-ku Tokyo, Japan
03-3822-2131
clinicaltrial@nms.ac.jp
NO
2020 | Year | 07 | Month | 17 | Day |
https://pubmed.ncbi.nlm.nih.gov/33247348/
Published
https://pubmed.ncbi.nlm.nih.gov/33247348/
49
Among 49 patients, 6 (12.2%) had SGB, 4 (8.2%) possible RS, 29 (59.2%) FH, 9 (18.4%) RH, and 1 (2%) NERD. Possible RS patients had more postprandial non-acid reflux events than FH patients (p < 0.05). The multivariate logistic regression analysis did not identify any predictive factors with statistical significance.
2022 | Year | 07 | Month | 19 | Day |
We retrospectively analyzed high-resolution manometry (HRM), 24-h multiluminal impedance pH-metry (MIIpH), and esophagogastroduodenograms (EGD) in patients with VPZ-refractory reflux symptoms who were referred to our tertiary referral center in Tokyo, Japan between January 2015 and April 2020. Eligibility criteria were (i) 18 years or older; (ii) persistent reflux symptoms (heartburn or regurgitation) despite a 2-week treatment with 20 mg VPZ; (iii) never been diagnosed with reflux esophagitis; and (iv) adequate records of HRM, MIIpH on 20 mg VPZ, and EGD, which were performed within 6 months. This protocol was approved by the Ethics Committee for Human Research of Nippon Medical School [B-2020-152]. The present study was registered in the UMIN clinical trial register system [UMIN000041142].
We retrospectively analyzed high-resolution manometry (HRM), 24-h multiluminal impedance pH-metry (MIIpH), and esophagogastroduodenograms (EGD) in patients with VPZ-refractory reflux symptoms who were referred to our tertiary referral center in Tokyo, Japan between January 2015 and April 2020. Eligibility criteria were (i) 18 years or older; (ii) persistent reflux symptoms (heartburn or regurgitation) despite a 2-week treatment with 20 mg VPZ; (iii) never been diagnosed with reflux esophagitis; and (iv) adequate records of HRM, MIIpH on 20 mg VPZ, and EGD, which were performed within 6 months. This protocol was approved by the Ethics Committee for Human Research of Nippon Medical School [B-2020-152]. The present study was registered in the UMIN clinical trial register system [UMIN000041142].
none
The primary outcome was the proportion of patients with behavioral disorders (SGB and possible RS). The secondary outcome was predictive factors for behavioral disorders.
Completed
2020 | Year | 05 | Month | 01 | Day |
2020 | Year | 07 | Month | 17 | Day |
2020 | Year | 07 | Month | 17 | Day |
2020 | Year | 07 | Month | 31 | Day |
We retrospectively analyzed High Resolution Manometry (HRM), 24hour Multichannel Impedance pH-metry (MIIpH), and Esophagogastroduodenogram (EGD) in patients with VPZ-refractory reflux symptoms. We divided patients into 4 groups: Functional Heartburn, Reflux Hypersensitivity, Dupragastric Belching, Rumination Syndrome. We calculated the proportion of each group and investigated predictive factors if rumination syndrome and supragastric belching
2020 | Year | 07 | Month | 17 | Day |
2022 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046428
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