None listed
Conditions
Interventions
Drug, Procedure/Surgery : (1) Procedure for pancreatic tumor test subjects (EUS-PDT)
? Photolon ® (Belmedpreparaty, Belarus) 2.5-3.0 mg / kg, the next generation optics
3 hours before dosing.
? Ultras
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Criteria for selecting pancreatic tumor test subjects ? Stages that can not be operated (stage 3 ~ 4a) or systemic conditions or accompanying diseases character ? Pancreatic cancer that progresses locally without systemic metastasis despite conventional chemotherapy patient ? Under the judgment of the researcher, patients who are deemed to need a new treatment method corresponding to 1) and 2) ? Those diagnosed as adenocarcinoma histologically from pancreatic cancer ? Women who were not menopausal or sterilized were tested for serum ß-HCG negative can be used, and medically acceptable contraceptive methods should be used do. ? The Eastern Cooperative Oncology Group (ECOG) Subject ? Patients aged 19 or older who understood and agreed to this study 2) Criteria for selection of candidates for liver cancer ? Cholangiocarcinoma patients who need broad-band cure ? Those who are unable to perform surgery due to systemic conditions or accompanying diseases. ? Cholangiocarcinoma progressing locally without systemic metastasis despite conventional chemotherapy patient ? Under the judgment of the researcher, patients who are deemed to need a new treatment corresponding to 1) and 2) ? Patients aged 19 or older who understood and agreed to this study
Exclusion criteria
Exclusion criteria: 1) criteria for excluding pancreatic tumor test subjects ? Under 18 years old ? If you can not perform endoscopic ultrasound under sedation ? The subject who had previously received PDT for the pancreas ? hemorrhagic tendency, or those with related diseases or the following laboratory If you have a number - PT INR> 1.5 - platelet <50,000 - WBC <2.0x10? / l - hemoglobin <90 g / l - Hematocrit ratio <27% ? Those who have acute pancreatitis accompanied by a screening criterion within 4 weeks ? If there is no willingness to follow up or if the patient does not agree with the procedure ? pregnant or lactating ? Those participating in other drug clinical trials before 30 days on screening basis. However, Participating subjects can be registered ? Candidates who have known hypersensitivity to known porphyria ? If there are other neoplasms other than cervical intraepithelial carcinoma or skin basal cell carcinoma, Subjects with a history of other neoplasms treated within 5 years ? Intermediate-level dysfunction with a parameter of grade 3 or higher according to the adverse reaction term standard. ? Cockcroft-Gault equation with calculated creatinine clearance <45 ml ? If the Eastern Cooperative Oncology Group (ECOG) Score is more than 3 levels ? Others Those who are deemed difficult to perform the clinical trial when the test taker judges 2) Criteria for excluding patients to be tested for cholangiocarcinoma ? Under 18 years old ? If you can not perform endoscopic ultrasound under sedation ? Uncorrected coagulation disorder (PT INR> 1.5, platelet <50,000) ? Those with acute pancreatitis ? If there is no willingness to follow up or if the patient does not agree with the procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of necrotic tissue (diameter of treated necrotic tissue/diameter of original tumor x100) | — |
Secondary
| Measure | Time frame |
|---|---|
| technical success | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Seon Lee
Asan Medical Center
Outcome results
None listed