digestive tract disease
Conditions
Interventions
experimental group:plasma radiofrequency generator and electrosurgical knife
control group:electrosurgical system and electrosurgical knife
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and willing to participate in this clinical trial, and voluntarily sign the informed consent; 2. Ages >= 18 years and <= 70 years, male or female; 3. Patients has lesions within the Gastrointestinal (GI) tract, and suitable for the indication of ESD (Endoscopic Submucosal Dissection) procedure; If the answer to any one question above is No, the patient shall be excluded from this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patient with contraindication of ESD procedure. 2. Patient with coagulations disorders which is the contraindication to surgical procedures, or is still taking anticoagulant one week before surgery. 3. Patient with severe cardiopulmonary insufficiency who cannot tolerate the operation; 4. Women of childbearing age with blood pregnancy or urine pregnancy test yielding a positive result, or in lactation period; 5. Patient with cardiac pacemakers or other electronic implants; 6. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation of the study. If the answer to any one question above is Yes, the patient shall be excluded from this clinical trial. Note: Coagulation disorder is indicated by prolonged Prothrombin Time (PT) for more than 3 seconds (5 seconds if patient has liver disease), or prolonged activated partial thromboplastin time (APTT) for more than 10 seconds, or Platelet count (PLT) is less than 70 x 10^9/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| En bloc resection success rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of coagulation;Device performance evaluation;Incidence of bleeding during operation;Incidence of perforation during operation;Incidence of bleeding post-toperative;Incidence of perforation post-operation; | — |
Countries
China
Contacts
Public ContactPinghong Zhou
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed