None listed
Conditions
Interventions
Medical Device : In patients diagnosed with LAPC/BRPC and planned chemotherapy using FOLFIRINOX, HIFU/FOLFIRINOX combined treatment is performed on patients who agree to this study. The combined treat
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults over 19–85 2. Persons with a Karnofsky Performance Scale (KPS) of 70 percent or more; 3. A person diagnosed as a tubular adenocarcinoma through biopsy. 4. A person diagnosed with LAPC/BRPC by computed tomography (CT) or magnetic resonance imaging (MRI) - Diagnosis results based on CT or MRI taken at the hospital where pancreatic cancer was first diagnosed or being treated are recognized as valid. However, only the results obtained within 4 weeks from the screening date are accepted. - LAPC/BRPC is determined by investigators based on the American Point Committee on Cancer (AJCC) guidelines (see table below). T staging T1 Tumor diameter 4cm T4 Invasion of the celiac trunk, the superior mesenteric artery, and proper hepatic artery, regardless of tumor size. N staging N0 No LN metastasis N1 Regional LN metastasis 1~3 N2 Regional LN metastasis 4 or more M staging M0 No distant metastasis M1 Distant metastasis - Cases with distant metastasis are excluded; LAPC indicates T4NxM0; and BRPC indicates when T4 is not clear with NxM0. 5. A person willing to voluntarily agree to a clinical trial and comply with the test plan
Exclusion criteria
Exclusion criteria: 1. The presence of a cystic lesion within pancreatic cancer to be treated with HIFU or at the pancreas adjacent to the pancreatic cancer. 2. The presence of a wide range of scar or surgical clips observed in the passage through the ultrasonic beam. 3. In case proper ultrasound images for HIFU procedures are not shown 4. A person who cannot lie down in a comfortable position. 5. A person who has difficulty communicating 6. A person who has experience in toxic or hypersensitive reactions to FOLFIRINOX anticancer drugs. 7. A person pregnant or breastfeeding 8. Pancreatic cancer patients who have previously been anti-cancer treatment 9. If severe side effects such as aortic rupture, duodenum perforation, gastrointestinal damage or intestinal necrosis are expected due to HIFU procedures. 10. Other cases where participation in this clinical trial is judged inappropriate by the investigator (specific reasons should be recorded in the case report form)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response ;Percentage of subjects who underwent surgical resection | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-Progression;Overall survival rate | — |
Countries
Korea, Republic of
Contacts
Public ContactSoo Yeon Kang
Seoul National University Hospital
Outcome results
None listed