A clinical study to evaluate 5-ALA for pancreatobiliary cancer
- Conditions
- Biliary cancer, pancreatic cancer
- Registration Number
- JPRN-jRCTs011210015
- Lead Sponsor
- Tanaka Kimitaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
(1) over 20 years old
(2) Patients who undergo surgery for malignant tumors in the biliary and pancreatic regions (limited to patients with malignant tumors confirmed by preoperative histological examination)
(3) patients who has obtained written consent
(1) Patients with contraindications to 5-ALA: a. Patients with a history of hypersensitivity to porphyrin, b. Patients with porphyria, c. Patients recieving drugs or foods known to cause photosensitivity (tetracycline antibiotics, sulfonamides, new quinolones, hypericin or Hypericum perforatum (St. John's Wort)), d. a pregnant woman or a woman who may be pregnant
(2) Patients with preoprative liver impairment of 1.5 times or more than the normal value in the laboratory test.
(3) Patients with preoperative renal impairment with an eGFR of less than 50 or patients on dialysis
(4) Patients with a history of ischemic heart disease
(5) Pregnant women, lactating women and female patients who wish to become pregnant
(6) Patients with heart pacemaker or implantable cardiac defibrillator
(7) Patients whom the principal resercher determined to be unsuitable for study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of 5-ALA to the main tumor with fluorescence diagnosis
- Secondary Outcome Measures
Name Time Method