Unique ID issued by UMIN | UMIN000004249 |
---|---|
Receipt number | R000005103 |
Scientific Title | The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms |
Date of disclosure of the study information | 2010/09/22 |
Last modified on | 2013/03/24 09:37:50 |
The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms
Metalic stent for esophageal benign stricture
The feasibility of a metalic stent for Esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms
Metalic stent for esophageal benign stricture
Japan |
superficial esophageal squamous cell neoplasms
Gastroenterology |
Malignancy
NO
To evaluate the feasibility of the metalic stent placement, followed by stent removal after a period, for esophageal benign stricture after endoscopic submucosal dissection for superficial esophageal squamous cell neoplasms.
Safety,Efficacy
Confirmatory
Phase II
Incidence of the complication related with metalic stent placement.
1) Incidence of the re-stricture after stent removal
2) Duration of stricture-free or symptom-free period
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Place a metalic stent for esophageal benign stricture.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1. age; 20-80 years-old
2. with esophageal benign stricture after endoscopic submucosal dissection for esophageal squamous cell neoplasms.
3. with re-stricture after endoscopic balloon dilation for esophageal benign stricture.
4. Performance status: 0, 1.
5. with or without multiple stricture.
6. without organ failure.
7. without serious complication.
8. obtained written informed consent.
1. post operative status of esophagectomy.
2. with overt infection or inflammation of esophagus.
3. inappropriate for this study.
5
1st name | |
Middle name | |
Last name | Hirohisa Machida |
Osaka City University Graduate School of Medicine
Department of Gastroenterology
1-4-3, Asahi-machi, Abeno, Osaka, Japan
06-6645-3811
1st name | |
Middle name | |
Last name | Hirohisa Machida |
Osaka City University Graduate School of Medicine
Department of Gastroenterology
1-4-3, Asahi-machi, Abeno, Osaka, Japan
06-6645-3811
Osaka City University Graduate School of Medicine
Osaka City University Graduate School of Medicine
Self funding
NO
2010 | Year | 09 | Month | 22 | Day |
Unpublished
Terminated
2010 | Year | 07 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 22 | Day |
2013 | Year | 03 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005103
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |