Unique ID issued by UMIN | UMIN000021568 |
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Receipt number | R000024868 |
Scientific Title | Exploratory research on latent esophageal motility disorders in non-erosive gastroesophageal reflux disease (NERD) resistant to proton-pump-inhibitors (PPIs) |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2016/03/22 17:59:08 |
Exploratory research on latent esophageal motility disorders in non-erosive gastroesophageal reflux disease (NERD) resistant to proton-pump-inhibitors (PPIs)
esophageal motility disorders in NERD
Exploratory research on latent esophageal motility disorders in non-erosive gastroesophageal reflux disease (NERD) resistant to proton-pump-inhibitors (PPIs)
esophageal motility disorders in NERD
Japan |
non-erosive gastroesophageal reflux disease (NERD) resistant to proton-pump-inhibitors (PPIs)
Gastroenterology |
Others
NO
To evaluate latent esophageal motility disorders associated with PPI-resistant NERD.
Safety
The study was carried with patients who had been diagnosed as having PPI-resistant NERD, showed no erosive esophageal mucosal damage, and showed no alleviation of dysphagia symptoms after administration of standard doses of PPIs for at least 8 weeks. After enrolment, the presence or absence of esophageal motility disorder was evaluated on the basis of the Chicago classification, using HRM.
Efficacy of the PPI for NERD
Others,meta-analysis etc
20 | years-old | <= |
90 | years-old | > |
Male and Female
(i) Principal complaint: dysphagia.
(ii) Organic disease ruled out by upper gastrointestinal endoscopy.
(iii) Experienced no alleviation of symptoms despite use of the standard PPI dose for at least 8 weeks.
(i) Drug administration and/or endoscope insertion made difficult by constriction or deformation of the upper gastrointestinal tract.
(ii) Suffering from active malignant tumors, or other serious, systemic complications.
(iii) Suffering from active ulcers.
(iv) Suffering from serious complications, such as heart, kidney, liver, or respiratory failure.
(v) A history of treatment of the upper abdomen with radiotherapy.
(vi) A history of surgical treatment of the gastrointestinal tract.
100
1st name | |
Middle name | |
Last name | Toshihisa Takeuchi |
Osaka Medical Collage
Depertment of 2nd. internal medicine
2-7, Daigakumachi, Takatsuki-shi, Osaka, Japan
0726831221
in2097@poh.osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Toshihisa Takeuchi |
Osaka Medical Collage
Depertment of 2nd. internal medicine
2-7, Daigakumachi, Takatsuki-shi, Osaka, Japan
0726831221
in2097@poh.osaka-med.ac.jp
Depertment of 2nd. internal medicine, Osaka Medical Collage
none
Self funding
NO
2016 | Year | 04 | Month | 01 | Day |
Unpublished
The subjects of the study were 100 patients who suffered from dysphagia; were examined and treated at Hospital between July 2011 and December 2013; had organic disease ruled out by upper gastrointestinal endoscopy; showed no alleviation of symptoms despite administration of the standard dose of a PPI for at least 8 weeks; were at least 20 years old; and were diagnosed as having PPI-resistant NERD. The mean age was 59.31years, and 45 males and 55 females were included, with mean ages of 58.80 and 59.73 years, respectively.
Completed
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 07 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 03 | Month | 01 | Day |
The breakdown of the 100 subjects was by classification of disease types in accordance with the flowchart in the 2012 Chicago classification criteria.
Firstly, 29 subjects were found to have IRP values, used to evaluate the residual pressure at relaxation of the lower esophageal sphincter, of 15 mmHg or higher. Of these patients, 13 had achalasia, with no normal primary peristaltic waves (Fig. 2); and 16 had EGJ outflow obstruction, with normal primary peristaltic waves (Fig. 3). Next, the group of subjects with IRPs below 15 mmHg consisted of three subjects with diffuse esophageal spasms, with distal latency periods of less than 4.5 s; and seven subjects with hypertensive peristalsis, defined as a distal contractile integral, used to evaluate the strength of peristaltic wave contraction, of at least 5000 mmHg/s/cm (Fig. 4). In addition to the above subjects, 14 subjects had weak peristalsis, with breaks of 2 cm or more in the 20-mmHg isobar (Fig. 5); and five had frequent failed peristalsis, with at least three peristaltic failures in 10 swallowing events. Furthermore, 40 subjects with whom all the above conditions were ruled out were judged to be normal. Finally, there were two subjects with whom insertion was not possible, of whom one was diagnosed as having achalasia on the basis of barium swallowing (Fig. 6), whereas with the other barium swallowing resulted in the barium remaining in the pharynx, indicating the impatency of the pharynx, so the condition was re-diagnosed as oropharyngeal dysphagia.
2016 | Year | 03 | Month | 22 | Day |
2016 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024868
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