Unresectable bile duct carcinoma
Conditions
Interventions
Laserphyrin
Sponsors
University of Miyazaki Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Cases diagnosed as remarkable bile duct carcinoma by 1) and 2) 1)Typical diagnosis by imaging analysis by ultrasonography, CT, MRI, ERCP etc. 2)Typical diagnosis by tumor biopsy, cytology or postoperative tissue specimens (2)Cases who are expected the improvement of prognosis by local control using other systemic chemotherapy (3)Presence of distant metastasis or node metastasis is not required. (4)Presence of stent treatment at the site of bile duct stenosis by the tumor is not required. (5)At the time of informed consent, patients over 18 years old who are spontaneously acceptable for agreement (6)Patients with performance Status (ECOG) ranged as 0-2, or Karnofsky Performance Index equal to or more than 50 (7)Patients who are relieved the obstructive jaundice(T-Bil less than 5mg/dl) (8)Patients with stable cardiac, pulmonary, hepatic, renal and bone marrow functions as below; a. Renal function;BUN and serum creatine level equal to or less than 1.5 times of the upper limit of institutional normal range b.Hepatic function;AST(GOT) and ALT(GPT) equal less than 100IU/L c. Blood; neutrophil equal to or more than 1,500/mm3, platelet count equal to or more than 100,000/mm3,Hb equal to or more than 8.5g/dl d. Cardiac function; no serious abnormality by ECG e. Lung function;Arterial oxygen concentration(SpO2) equal to or more than 94% (under administration of oxygen) (9)After the enough informed connsent for attempting in the present study, patients who well understand and provide agreement of documents by the patient's spontaneous will
Exclusion criteria
Exclusion criteria: (1)Patients requiring radiation therapy as a local treatment (2)Patients who cannot receive laser irradiation to the tumor by any reasons (3)Patients with serious co-morbidity(malignant hypertension, severe congestive cardiac failure, severe hepatic failure, cardiac infarction withtin 3 months, terminal stage of cirrhosis, uncontrolled diabetes,severe pulmonary fibrosis, active interstitial peumonitis etc) (4)Patients with uncontrolled infectious diseases including actibe tuberclosis (5)atients who are difficult to limitatehospital stay under dark room (6)Porphyria patients (7)Patients diagnosed as severe mental disorders or dementia (8)Patients who attend other clinical study (9)Patients who are hypersensitive for laserphyrin (10)Female patients with pregnancy, pregnant-suspicious and breast-feeding (11)Unresctable bile duct patients in whom the better prognosis are not expected by the researcher's judgement. (12)Other patients who are not stable for clinical study by the judgement of attendant doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| presence or absence of photosensitivity after treatment of PDT | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival period, tumor progression-free survival, period until bilairy stent obstruction, tumor response rate, other adverse event, changes of blood concentration of porphyrin, disease-control rate during follow-up after day 56 of PDT treatment | — |
Countries
Japan
Contacts
Public ContactAtsushi Nanashima
University of Miyazaki Faculty of Medicine Division of Hepato-biliary-pancreatic Surgery
Outcome results
None listed