Unique ID issued by UMIN | UMIN000041599 |
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Receipt number | R000046201 |
Scientific Title | Clinical trial of the efficacy of traction method with a band in endoscopic submucosal dissection for colorectal tumor |
Date of disclosure of the study information | 2020/09/01 |
Last modified on | 2023/09/26 08:10:29 |
Clinical trial of the efficacy of traction method with a band in endoscopic submucosal dissection for colorectal tumor
Traction band trial
Clinical trial of the efficacy of traction method with a band in endoscopic submucosal dissection for colorectal tumor
Traction band trial
Japan |
Colorectal tumor
Gastroenterology |
Malignancy
NO
To confirm the usefulness of traction using a band in endoscopic submucosal dissection (ESD) for colorectal tumor.
Efficacy
Rate of submucosal resection during colorectal ESD
Procedure time of colorectal ESD,
Adverse event during ESD,
Adverse event after ESD,
Colorectal ESD procedure time and adverse events for each operator,
Procedure time according to macroscopic type,
Pathological assessment (size, adenoma or cancer, depth of cancer, en bloc resection rate, complete en bloc resection rate)
Time required to attach band
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Maneuver |
Conventional ESD group
Band-assisted ESD group
20 | years-old | <= |
Not applicable |
Male and Female
1)Early colorectal cancer, size: > 20mm and <= 30mm, depth of cancer invasion: M or SM1.
2)Adequate organ functions defined as;
Hemoglobin of 8.0 g/dl or more
Platelet count 100,000 or more
3)Aged 20 years old or more
4)PS(ECOG), 0 or 1.
5)Written informed consent
1)Patients with lesions in the Rb.
2)Patients with multiple lesions to be treated.
3)Patients with a bleeding tendency.
4)Patients deviating from the "Gastrointestinal endoscopy practice guidelines for antithrombotic drug recipients (including supplements)" and patients who cannot comply.
5)During dialysis.
6)Inflammatory bowel disease or familial adenomatous polyposis.
7)Lesion on the endoscopic resection scar (EMR or ESD)
8)Past history of colectomy or radiotherapy.
9)Patient considered unsuitable for a clinical trial as determined by the clinician.
60
1st name | Hiroshi |
Middle name | |
Last name | Yasuda |
St. Marianna University School of Medicine Hospital
Gastroenterology and Hepatology
216-8511
2-16-1 Sugao, Gastroenterology and HepatologyMiyamae-ku, Kawasaki-shi, Kanagawa
0449778111
hyasuda@marianna-u.ac.jp
1st name | Yasumasa |
Middle name | |
Last name | Matsuo |
St. Marianna University School of Medicine Toyoko Hospital
Gastroenterology and Hepatology
211-0063
3-435, Kosugimachi, Nakahara-ku, Kawasaki, Kanagawa
044-722-2121
yasumasa_matsuo@marianna-u.ac.jp
St. Marianna University School of Medicine Hospital
St. Marianna University School of Medicine
Other
St. Marianna University School of Medicine
2-16-1 Sugao, Gastroenterology and HepatologyMiyamae-ku, Kawasaki-shi, Kanagawa
0449778111
k-sienbu.mail@marianna-u.ac.jp
NO
2020 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2020 | Year | 08 | Month | 29 | Day |
2020 | Year | 08 | Month | 14 | Day |
2020 | Year | 09 | Month | 14 | Day |
2023 | Year | 03 | Month | 31 | Day |
2020 | Year | 08 | Month | 29 | Day |
2023 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046201
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