Unique ID issued by UMIN | UMIN000018167 |
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Receipt number | R000019817 |
Scientific Title | The usefulness of endoscopic submucosal dissection (ESD) with continuous aspiration catheter attached outside the endoscope for superficial esophageal carcinoma |
Date of disclosure of the study information | 2015/07/02 |
Last modified on | 2020/01/04 09:43:02 |
The usefulness of endoscopic submucosal dissection (ESD) with continuous aspiration catheter attached outside the endoscope for superficial esophageal carcinoma
Esophageal aspiration catheter study
The usefulness of endoscopic submucosal dissection (ESD) with continuous aspiration catheter attached outside the endoscope for superficial esophageal carcinoma
Esophageal aspiration catheter study
Japan |
Superficial esophageal cancer
Gastroenterology |
Malignancy
NO
To evaluate the efficacy of continuous aspiration catheter attached outside the endoscope in performing endoscopic submucosal dissection for superficial esophageal cancers
Efficacy
Excretion from the mouth in performing esophageal ESD
the rate of (aspiration) pneumonia after performing esophaeal ESD
the time in performing esophageal ESD
the relationship between inserting water for washing from the endoscope and excretion from the mouth in performing esophageal ESD
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment |
esophageal ESD with continuous aspiration catheter
esophageal ESD without continuous aspiration catheter
20 | years-old | <= |
Not applicable |
Male and Female
1) The patients with previous surgery in esophagus, stomach, or head and neck.
2) The patients with the diagnosis of esophageal stenosis or achalasia
1) The patients with previous surgery in esophagus, stomach, or head and neck.
2) The patients with the diagnosis of esophageal stenosis or achalasia
3) The patients with chemoradiotherapy for any cancer
4) The patients with underlying diseases which does not permit the use of butylscopolamine
50
1st name | Waku |
Middle name | |
Last name | Hatta |
Tohoku University Graduate School of Medicine
Division of Gastroenterology
980-8574
1-1 Seiryo-machi, Aoba-ku, Sendai
022-717-7171
waku-style@festa.ocn.ne.jp
1st name | Waku |
Middle name | |
Last name | Hatta |
Tohoku University Graduate School of Medicine
Division of Gastroenterology
980-8574
1-1 Seiryo-machi, Aoba-ku, Sendai
022-717-7171
waku-style@festa.ocn.ne.jp
Division of Gastroenterology, Tohoku University Graduate School of Medicine
Division of Gastroenterology, Tohoku University Graduate School of Medicine
Other
The Ethics Committee, Tohoku University Hospital
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
022-717-7122
med-kenkyo@bureau.tohoku.ac.jp
NO
2015 | Year | 07 | Month | 02 | Day |
None
Published
https://www.ncbi.nlm.nih.gov/pubmed/30861606
50
Volume of liquid reflux to the mouth was significantly lower in the continuous liquid-suction catheter attachment for the endoscope-endoscopic submucosal dissection group (CLCA-ESD group) than in the conventional endoscopic submucosal dissection group (C-ESD group) (mean: 10 vs 73 mL, P = 0.010).
2020 | Year | 01 | Month | 04 | Day |
There was no significant difference of baseline characteristics of the enrolled patients between the two groups.
Fifty patients who met the eligibility criteria but did not meet the exclusion criteria were randomly assigned to the CLCA-ESD or C-ESD groups, and completed this study.
None
Volume of liquid reflux to the mouth:
CLCA-ESD group, mean 10 mL
C-ESD group, mean 73 mL
Completed
2015 | Year | 05 | Month | 20 | Day |
2015 | Year | 06 | Month | 26 | Day |
2015 | Year | 12 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2015 | Year | 07 | Month | 02 | Day |
2020 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019817
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