An exploratory clinical study to evaluate the usefuleness of 5-aminolevulinic acid for pancreatobiliary malignant tumor

Tanaka Kimitaka0 个研究点目标入组 15 人开始时间: 2021年6月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(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

发起方

Tanaka Kimitaka