Endoscopy (ultrasound endoscopy, retrograde pancreatic endoscopy, percutaneous transhepatic endoscopy) photodynamic therapy using next-generation photosensitizers and laser probes in patients with locally advanced pancreatic and hepatic ductal carcinoma without response to conventional therapy
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001763
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 65
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of necrotic tissue (diameter of treated necrotic tissue/diameter of original tumor x100)
- Secondary Outcome Measures
Name Time Method technical success