JPRN-jRCTs011210015
Recruiting
Phase 1
An exploratory clinical study to evaluate the usefuleness of 5-aminolevulinic acid for pancreatobiliary malignant tumor
Tanaka Kimitaka0 sites15 target enrollmentJune 4, 2021
ConditionsBiliary cancer, pancreatic cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Biliary cancer, pancreatic cancer
- Sponsor
- Tanaka Kimitaka
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
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