A clinical study to evaluate 5-ALA for pancreatobiliary cancer

JRCT ID: jRCTs011210015

Registered date:04/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary cancer, pancreatic cancer
• Date of first enrollment: 15/06/2021
• Target sample size: 15
• Study type: Interventional

Intervention(s)

5-ALA is dissolved in water and orally administered at 20 mg/kg at 3 hours before induction of anesthesia.
Prior to radical resection of the lesion, the presence or absence of liver metastasis, peritoneal dissemination, and lymph node metastasis is assessed using camera. The specimens of intraoperative frozen section diagnosis is evaluated by using camera.

Outcome(s)

• Primary Outcome: Sensitivity of 5-ALA to the main tumor with fluorescence diagnosis

Secondary Outcome

(1) Sensitivity, specificity, and ROC curves for the diagnosis of metastasis by fluorescence diagnosis and spectroscopy for main tumors, lymph nodes, and other lesions suspected to be metastasis
(2) Comparison of mapping of the extent of tumor spread detected by luorescence diagnosis and spectroscopy and mapping by pathological diagnosis
(3) The sensitivity, specificity, ROC curve for the diagnosis of residual tumor by fluorescence diagnosis and spectroscopy at the cut end margin. Investigate the pathological distance from the tumor at cut end margin.
(4) The Differences in the sensitivity, specificity, and ROC curves for the diagnosis of metastasis by fluorescence diagnosis and spectroscopy in histological type, non-invasive cancer, and tumor volume of cancer.
(5) Investigate the cutoff values of fluorescence spectra and intensity in cancer diagnosis
(6) Estimation of the intensity of the fluorescence spectrum in normal tissues (liver, bile duct, pancreas, spleen, duodenum, and lymph nodes)
(7) Investigate the cutoff values of fluorescence spectra and intensity in each primary site of cancer
(8) Comparison of the diagnostic capability between two devices.
(9) The relationship between fluorescence diagnosis at the cut end margin and prognosis including the pattern of recurence

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tanaka Kimitaka