Familial adenomatous polyposis (FAP), Multiple duodenal polyposis
Conditions
Interventions
Cold snare polypectomy is performed for multiple duodenal adenomas, then the patients will be followed -up endoscopically and histological tissue examination of duodenal adenomas will be performed.
Sponsors
Osaka International Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Spigelman stage of I-IV disease. (2) Performance status (ECOG) of 0-2. (3) Meeting all of the following criteria without blood transfusion in the past 14 days. i) Hb: >=9.0 g/dl ii) Plt: >=100000 /mm3 iii) AST, ALT: <=150 U/l iv) Cre: <=2.0 mg/dl v) PT%: >= 70 % (4) Available to be observed more than a year after the intervention. (5) Written informed consent.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Adverse event rate (during the 28 days after the intervention, >= CTCAE v4.0 Grade 3) Phase II: Downstaged patient rate using Spigelman staging system (at follow-up endoscopy a year after the intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I (1) Arterial bleeding rate (during the procedure) (2) Adverse event rate (during the 28 days after the intervention) (3) Procedure time Phase II: (1) Spigelman score (stage) differences between pre-procedure and post-procedure (at follow-up endoscopy 2-3 months after the intervention and a year after the intervention) (2) Arterial bleeding rate (during the procedure) (3) Adverse event rate (during the 28 days after the intervention, >= CTCAE v4.0 Grade 3) (4) Adverse event rate (during the 28 days after the intervention) (5) Procedure time | — |
Countries
Japan
Contacts
Public ContactYoji Takeuchi
Osaka International Cancer Institute Department of Gastrointestinal Oncology
Outcome results
None listed