Unique ID issued by UMIN | UMIN000015605 |
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Receipt number | R000018131 |
Scientific Title | Efficacy of esophageal stenting for refractory benign esophageal stricture after esophageal cancer and gastric cancer surgery |
Date of disclosure of the study information | 2014/11/05 |
Last modified on | 2019/05/20 23:02:06 |
Efficacy of esophageal stenting for refractory benign esophageal stricture after esophageal cancer and gastric cancer surgery
Efficacy of esophageal stenting for refractory benign esophageal stricture
Efficacy of esophageal stenting for refractory benign esophageal stricture after esophageal cancer and gastric cancer surgery
Efficacy of esophageal stenting for refractory benign esophageal stricture
Japan |
refractory benign esophageal stricture
Gastroenterology | Gastrointestinal surgery |
Others
NO
To evaluate the safety and efficacy of removable esophageal stent for refractory benign esophageal strictures after esophageal cancer and gastric cancer surgery
Safety,Efficacy
Exploratory
Onset rate of restenosis after esophageal stent removal
Proportion of dysphagia score improvement at 1-month after stent removal
Proportion of stricture improvement at 5-month after stent removal
Occurrence rate and the types of adverse events
Periods to the onset of restenosis
Occurrence rate of stent slippage
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
Esophageal stent placement
Flexella-J esophageal stent
20 | years-old | <= |
Not applicable |
Male and Female
Patients with refractory benign esophageal stricture who underwent a history of dilatation procedure for benign esophageal stricture after esophageal cancer and gastric cancer surgery which meets one or both of the following criteria.
1) Dysphagia score of >= 2
2) Endoscope (diameter of 9-11 mm) could not pass the stricture.
3) Non-malignant finding with endoscopic examination.
4) ECOG performance status of 0-3.
5) >= 20 years old.
6) Patients with informed concent.
1) Patients with neoplastic lesions in the stenosis
2) Stenosis is in the high esophagus and the upper edge of the stent is assumed to contact with the esophageal entrance
3) Patients with a fistula in the stenosis
4) Stenosis length is more than 10cm
5) Patients with bleeding tendency
6) Patients who underwent radiation therapy
7) Women that there is a possibility of pregnancy or during pregnancy
8) Patient is judged to be inappropriate for enrollment of the study for any reason by the investigator
15
1st name | Koichi |
Middle name | |
Last name | Okamoto |
Kanazawa University, Graduate School of Medical Science
Division of Cancer Medicine
920-8641
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
0762652362
okamoto.k@staff.kanazawa-u.ac.jp
1st name | Koichi |
Middle name | |
Last name | Okamoto |
Kanazawa University, Graduate School of Medical Science
Division of Cancer Medicine
920-8641
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
0762652362
okamoto.k@staff.kanazawa-u.ac.jp
Kanazawa University, Graduate School of Medical Science
Kanazawa University, Graduate School of Medical Science
Self funding
Kanazawa University, Graduate School of Medical Science
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
076-265-2362
076-265-2362
NO
2014 | Year | 11 | Month | 05 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000018131
Unpublished
4
Terminated
2014 | Year | 11 | Month | 05 | Day |
2014 | Year | 08 | Month | 25 | Day |
2014 | Year | 11 | Month | 05 | Day |
2018 | Year | 11 | Month | 29 | Day |
2018 | Year | 11 | Month | 29 | Day |
2018 | Year | 11 | Month | 29 | Day |
2018 | Year | 11 | Month | 29 | Day |
2014 | Year | 11 | Month | 04 | Day |
2019 | Year | 05 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018131
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