臨床研究等提出・公開システム

Single-arm intervention clinical trial with low-dose aspirin in patients with familial adenomatous polyposis (J-FAPP Study V)

J-FAPP Study V (J-FAPP Study V)

Mutoh Michihiro

University Hospital Kyoto Prefectural University of Medicine

Kawaramachi-hiroko-ji, Kamigyo-ku, Kyoto 602-8566

mimutoh@koto.kpu-m.ac.jp

Mutoh Michihiro

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Kawaramachi-hiroko-ji, Kamigyo-ku, Kyoto 602-8566

+81-75-251-5339

mimutoh@koto.kpu-m.ac.jp

Not Recruiting

Dec. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

1) Patients with familial adenomatous polyposis.
2) No colectomy (Except for an appendectomy).
3) Those who have had all colorectal polyps of 5.0 mm or more removed endoscopically and no remaining polyps of 5.0 mm or more.
4)16 to 70 years old (regardless of sex)
5) The patient has given written consent prior to enrollment in this study.

Those who fall under any of the following are not included in this study.
1) Those who are currently taking antithrombotic agents and anticoagulants (trade names: biaspyrin, bufferin, panaldine, warfarin, persantin, etc.).
2) A history of stroke (transient ischemic attack: including TIA).
3) Patients with a history of treatment for gastric ulcer and duodenal ulcer . (Those who have confirmed S2 healing of ulcers after successful eradication of Helicobacter pylori, can participate)
4) Easy occurrence of inflammatory bowel disease (ulcerative colitis, Crohn's disease), hemorrhagic diverticulitis, severe hemorrhagic gastritis, etc.
5) Those with bleeding tendency, platelet count 100,000 / ul or less, white blood cell 3,000 / ul or less.
6) A person with a malignant tumor that is progressive or requires treatment at the time of entry. (except undergone curative resection).
7) Those who are undergoing anti-cancer drug treatment or radiation therapy.
8) Those who have a history of allergies to aspirin or the preparation of salicylic acid.
9) Those who are pregnant and plan to become pregnant during the study period.
10) Those who take NSAIDs at least 3 times a week for pain relief.
11) Those who took sulindac for the purpose of reducing polyps, but not have passed 6 months after stopping it.
12) Smokers (including heated cigarettes)

Both

Familial adenomatous polyposis

Low-dose aspirin enteric coated tablets (100 mg / day) for 2 years

Hereditary, polyposis, APC gene

D126 (CJHJ)

Cumulative rate of polyps of 5.0 mm or more over 2 years (8th, 16th, 24th month).

1. Cumulative incidence of high-grade dysplasia, cancer, and polyps for 2 years
2. Number of polyps with a cumulative size of 5.0 mm or more for 2 years and number of polyps removed
3. Difference in the incidence of colorectal polyps of >= 5.0 mm between Months 8 and 24
4. Increase or decrease in tumors throughout the large intestine
5. Multiple photographs of the cecum, splenic flexure, and lower rectum are taken, and the radiographic evaluation committee determines the increase or decrease in adenomas < 5.0 mm before and after administration under a blind condition.
6. Increase or decrease in upper gastrointestinal tract tumors
7. Presence or absence of adverse events
8. Proportion of patients with severe disease such as cancer or conversion to the dense form
9. The presence or absence of colorectal surgery during the intervention period
10. The number of cases of cancer in other organs during the observation period.
11. Intervention-Related pathological tissue changes

+81-3-3542-2511

Nov. 11, 2021

No

none