Unique ID issued by UMIN | UMIN000018742 |
---|---|
Receipt number | R000021685 |
Scientific Title | Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis -2 |
Date of disclosure of the study information | 2015/08/21 |
Last modified on | 2021/08/24 11:53:29 |
Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis -2
Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with FAP -2 (J-FAPP Study 3-2)
Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with familial adenomatous polyposis -2
Intervention trial for colorectal cancer prevention by endoscopic polypectomy in patients with FAP -2 (J-FAPP Study 3-2)
Japan |
Patients with familial adenomatous polyposis
Gastroenterology |
Others
NO
To evaluate the usefulness and safety of thorough endoscopic polypectomy in patients with FAP.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Whether or not a patient needs surgery on the large intestine during the intervention period. It includes not only the development of a polyp that cannot be removed endoscopically or that of large intestinal cancer, but also cases where a patient wishes to undergo resection of the large intestine because of discomfort of endoscopic examination, and cases where emergency surgery is performed because of perforation occurred during endoscopic treatment.
Presence or absence of the development of adverse events (perforation, hemorrhage, death from large intestinal cancer, and death from other causes), colorectal cancer, intramucosal carcinoma, or a tumor that is difficult to treat endoscopically.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Prevention
Maneuver |
Colonic polyps will be thoroughly removed by periodic colonoscopy.
16 | years-old | <= |
Not applicable |
Male and Female
Patients who have (or had) 100 or more adenomas in the large intestine and who refused to undergo surgery despite of being advised to do so, and who are 16 years or older (parental consent is required in patients younger than 20 years). Patients who have (or had) 100 or more adenomas in the large intestine and who had part of the large intestine resected by surgery but still have 10 cm or more of the large intestine, and who are 16 years or older (parental consent is required in patients younger than 20 years).
Patients who are considered by their attending physicians to be ineligible to participate in the study because they have a serious disease in other organs, or because they cannot discontinue antiplatelet drugs, or for other reasons.
Patients who are receiving anticancer drugs.
Patients with dense FAP in at least one-third of the large intestine.
Patients in whom strict follow-up is difficult.
200
1st name | Hideki |
Middle name | |
Last name | Ishikawa |
Kyoto Prefectural University of Medicine
Department of Molecular-Targeting Prevention
541-0042
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
06-6202-5444
cancer@gol.com
1st name | Hideki |
Middle name | |
Last name | Ishikawa |
Kyoto Prefectural University of Medicine
Department of Molecular-Targeting Prevention
541-0042
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
06-6202-5444
cancer@gol.com
Kyoto Prefectural University of Medicine
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
Kyoto Prefectural University of Medicine
602-8566 Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN
private
private
NO
石川消化器内科(大阪府)
札幌医科大学附属病院(北海道)
愛知県がんセンター中央病院(愛知県)
国立がん研究センター中央病院(東京都)
兵庫医科大学病院(兵庫県)
徳島大学病院(徳島県)
広島大学病院(広島県)
石川県立中央病院(石川県)
大阪国際がんセンター(大阪府)
佐野病院(兵庫県)
栃木県立がんセンター(栃木県)
岩国医療センター(山口県)
四国がんセンター(愛媛県)
群馬中央病院(群馬県)
がん研有明病院(東京都)
国立がん研究センター東病院(千葉県)
近畿大学医学部附属病院(大阪府)
東邦大学医療センター大橋病院(東京都)
京都大学医学部附属病院(京都府)
埼玉医科大学総合医療センター(埼玉県)
守口敬仁会病院(大阪府)
産業医科大学病院(福岡県)
帯広厚生病院(北海道)
九州大学病院(福岡県)
2015 | Year | 08 | Month | 21 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 08 | Month | 20 | Day |
2015 | Year | 09 | Month | 03 | Day |
2015 | Year | 09 | Month | 14 | Day |
2026 | Year | 09 | Month | 30 | Day |
2015 | Year | 08 | Month | 20 | Day |
2021 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021685
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