Endoscopic submucosal dissection of gastrointestinal polyps with a novel plasma radio frequency generator and a disposable mucosal incision knife: A prospective, multicenter, non-inferiority, randomized, controlled clinical trial
10.3760/cma.j.cn441530-20241025-00353
- VernacularTitle:新型等离子射频治疗仪和一次性黏膜切开刀对消化道病变行内镜黏膜下剥离术的前瞻性、随机对照、非劣效性多中心临床研究
- Author:
Baohui SONG
1
;
Guijun SHI
;
Xiaoyue XU
;
Jiaxin XU
;
Li FENG
;
Jianguang XU
;
Pinghong ZHOU
;
Mingyan CAI
Author Information
1. 复旦大学附属中山医院内镜中心，上海 200032
- Publication Type:Journal Article
- Keywords:
Plasma radiofrequency;
Gastrointestinal lesions;
Endoscopic submucosal dissection;
Noninferiority research
- From:
Chinese Journal of Gastrointestinal Surgery
2025;28(4):384-391
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of a new plasma radiofrequency generator and a disposable mucosal incision knife for endoscopic submucosal dissection (ESD) of gastrointestinal lesions.Methods:This study is a prospective, randomized, non-inferiority multicenter study (Chinese Clinical Trial Registry No.: ChiCTR2000041394). The inclusion criteria for cases are as follows: (1) being able to understand and voluntarily participate in this clinical trial, and voluntarily signing the informed consent form; (2) being 18-70 years old, regardless of gender; (3) having a gastrointestinal lesion and meeting the endoscopic treatment conditions for the indications of endoscopic submucosal dissection (ESD). The exclusion criteria are: (1) meeting the contraindications for ESD; (2) having a surgical contraindication due to coagulation dysfunction or still taking anticoagulants 1 week before surgery; (3) having coagulation dysfunction, that is, the prothrombin time is prolonged by more than 3 seconds (more than 5 seconds in patients with liver disease), or the activated partial thromboplastin time is prolonged by more than 10 seconds, and the platelet count is < 70×10?/L; (4) having severe cardiopulmonary insufficiency and being unable to tolerate the surgery; (5) being a reproductive-aged woman with a positive blood or urine pregnancy test or a lactating woman; (6) the investigator deems that there are other factors that are not suitable for inclusion or affect the subject's participation. Patients who underwent ESD treatment for gastrointestinal lesions from March 2019 to April 2023 at the Endoscopy Center of Zhongshan Hospital Affiliated to Fudan University, the Department of Gastroenterology of Minhang District Central Hospital in Shanghai, and the Department of Gastroenterology of Quzhou People's Hospital were prospectively included. The experimental group used a new plasma radiofrequency therapy instrument and a disposable mucosal incision knife, while the control group used a high-frequency electrosurgical system and a disposable mucosal incision knife. The primary efficacy indicator was the en bloc resection success rate, the secondary efficacy indicators included the coagulation success rate, and the operation stability of the plasma radiofrequency therapy instrument and the disposable mucosal incision knife; the safety indicators included the incidence of intraoperative bleeding, intraoperative perforation, and postoperative complications. Results:The study cohort comprised 194 patients, 95 in the experimental group and 99 in the control group. Analysis of the full set showed rates of en bloc resection of 97.89% (93/95) and 96.97% (96/99) in the experimental and control groups, respectively; the difference being 0.53% (-5.58%, 6.64%). Analysis of the compliance set showed rates of en bloc resection of 97.83% (90/92) and 96.88% (93/96) in the experimental and control groups, respectively; the difference being 0.58% (-5.79%, 6.94%). These data indicate that the rate of en bloc resection in the experimental group using plasma radiofrequency therapy and disposable mucosal incision was not inferior to that of the control group. The rates of achieving intraoperative coagulation in the experimental and control groups were 7.14% (5/70) and 5.97% (4/67), respectively; this difference is not statistically significant ( P=1.000). The control group had a significantly better rate of using the same instruments throughout the procedure than did the experimental group ( P<0.001). In the safety analysis set, the incidences of intraoperative and postoperative adverse events did not differ significantly between the two groups (both P>0.05). Conclusion:Plasma radiofrequency therapy equipment and a disposable mucosal incision knife are safe and effective instruments for performing ESD of gastrointestinal lesions.
