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Clinical trial using voltage steep pulse therapeutic apparatus for patients with pancreatic cancer

Clinical trial using voltage steep pulse therapeutic apparatus for patients with pancreatic cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078095
Enrollment
Unknown
Registered
2023-11-28
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Sponsors

Chinese PLA General Hostital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-80 years, male or female 2) Pancreatic malignancy patients with T4NOMO in stages II and III of the American Joint Committee on Cancer (AJCC) staging (8th edition) with clear pathological diagnosis (no more than 3 local lymph node metastases), both primary and recurrent patients can be treated; 3) tumor size (Measurement of maximum diameter in transverse axial position of preoperative enhanced MRI) must be=5cm; 4) Eastern Cooperative Oncology Group (ECOG) score of 0-2 , 5) Life expectancy of at least 3 months ,KPS score > 50 6) Subjects voluntarily signed informed consent forms

Exclusion criteria

Exclusion criteria: 1) Patients with severe arrhythmia, history of epilepsy or pacemaker implantation, as well as those who have recently experienced large-scale myocardial infarction; 2) Severe heart, lung, and kidney dysfunction or inability to tolerate general anesthesia with tracheal intubation; 3) Individuals who are allergic to contrast agents or unable to undergo MRI enhanced scanning for other reasons; 4) Blood routine examination within one week before surgery: hemoglobin<70 g/L or platelet count<80 × 10 ^ 9/L; 5) Individuals with metal stents or other metal implants within 2.5 cm of the ablation area; 6) Patients with invasion of the anterior portal vein system and concurrent occlusion of the main portal vein with portal hypertension and a large amount of ascites;; 7) Biliary obstruction and elevated bilirubin = 40 µ Mol/L; 8) Acute infection or acute phase of chronic infection; 9) Individuals with mental abnormalities or a history of mental illness who are unable to cooperate independently; 10) Individuals who have taken anticoagulant drugs or have abnormal coagulation function within one week; 11) Pregnant and lactating women, as well as those planning to conceive within one year; 12) Individuals who have participated in any clinical trials of drugs and/or medical devices within the three months prior to enrollment; 13) The researchers believe that there are any other factors that are not suitable for inclusion or that affect the participation of participants in the study.

Design outcomes

Primary

MeasureTime frame
Success rate of pancreatic tumor ablation;Effective rate of pancreatic tumor ablation;

Secondary

MeasureTime frame
ORR;CBR;DDC;

Countries

China

Contacts

Public ContactXiao Yueyong

Chinese PLA General Hostital

xiaoyueyong@126.com+86 13911710987

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026