A study to assess the feasibility, safety and efficacy of cold snare polypectomy for multiple duodenal adenomas in patients with familial adenomatous polyposis (a single center, prospective phase I/II study)
- Conditions
- Familial adenomatous polyposis (FAP), Multiple duodenal polyposis
- Registration Number
- JPRN-UMIN000022525
- Lead Sponsor
- Osaka International Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Not provided
(1) Endoscopic diagnosis of duodenal invasive cancer. (2) History of duodenectomy. (3) History of radiation therapy to the upper abdominal region. (4) Systemic administration (intravenously or orally) of corticosteroid. (5) Systemic administration (intravenously or orally) of either one or more drugs of anticoagulant agent or antiplatelet agent which cannot be suspended according to the Japanese guideline about antithrombotic agent. (6) Systemic administration of non-steroid anti-inflammatory drug which cannot be suspended through 7 days before to 28 days after the intervention. (7) Pregnant or lactation woman. (8) Diagnosis of psychiatric diseases. (9) With active bacterial or fungus infection. (10) History of myocardial infarction or unstable angina pectoris within 3 months. (11) With uncontrollable hypertension. (12) With severe respiratory disease requiring continuous oxygen therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method