Unique ID issued by UMIN | UMIN000042137 |
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Receipt number | R000048095 |
Scientific Title | Randomized controlled study of Balloon assisted endoscope versus conventional therapeutic endoscope in colonic endoscopic submucosal dissection for poorly operated right sided colonic lesion. |
Date of disclosure of the study information | 2020/10/20 |
Last modified on | 2024/03/15 13:37:28 |
Randomized controlled study of Balloon assisted endoscope versus conventional therapeutic endoscope in colonic endoscopic submucosal dissection for poorly operated right sided colonic lesion.
Randomized controlled study of BAESD vs ESD for poorly operated right sided colonic lesion.
Randomized controlled study of Balloon assisted endoscope versus conventional therapeutic endoscope in colonic endoscopic submucosal dissection for poorly operated right sided colonic lesion.
Randomized controlled study of BAESD vs ESD for poorly operated right sided colonic lesion.
Japan |
Superficial colorectal neoplasms
Gastroenterology | Adult |
Malignancy
NO
To evaluate the efficacy of BAESD compared with conventional ESD for poorly operated right sided colonic lesion.
Efficacy
Rate of ESD completion, dissection speed, procedure time
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
2
Treatment
Maneuver |
ESD using balloon assisted endoscope
ESD using therapeutic endoscope
20 | years-old | <= |
100 | years-old | > |
Male and Female
Superficial colonic neoplastic lesions of 20 mm or more and 50 mm or less that are present in the right sided colon and are judged to be poorly operated by preoperative examination endoscopy.
1)Lesions that extend to the appendix or ileocecal valve, lesions that extend into the diverticulum
2)Local recurrence after endoscopic resection.
3)Patients with Ulcerative colitis, Crohn disease.
4)Patients with hematological abnormality.
5)Patients with severe organ failure
6)Patients with lesions that are unreachable with a conventional endoscope.
7)Patients who have been judged as inappropriate for this study
30
1st name | Yoshikazu |
Middle name | |
Last name | Hayashi |
Jichi Medical University
Department of Medicine, Division of Gastroenterology
329-0498
3311-1 Yakushiji, Shimotsuke, Tochigi Japan
0285-58-7348
hayashi@jichi.ac.jp
1st name | Takaaki |
Middle name | |
Last name | Morikawa |
Jichi Medical University
Department of Medicine, Division of Gastroenterology
329-0498
3311-1 Yakushiji, Shimotsuke, Tochigi Japan
0285-58-7348
m05097tm@jichi.ac.jp
Jichi Medical University
none
Self funding
Jichi Medical University Clinical Research Ethics Committee
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
0285-58-7637
rinri@jichi.ac.jp
NO
2020 | Year | 10 | Month | 20 | Day |
Unpublished
Open public recruiting
2020 | Year | 09 | Month | 16 | Day |
2020 | Year | 10 | Month | 14 | Day |
2020 | Year | 10 | Month | 27 | Day |
2025 | Year | 03 | Month | 31 | Day |
2020 | Year | 10 | Month | 16 | Day |
2024 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048095
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