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临床试验/NCT05736705
NCT05736705撤回不适用

Randomized Controlled Trial Comparing Outcomes of Monopolar Current Cutting Knife and Bipolar RFA Knife in Esophageal Endoscopic Submucosal Dissection

Baylor College of Medicine2 个研究点 分布在 1 个国家开始时间: 2023年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Speed of Endoscopic Submucosal Dissection

研究概览

简要总结

The objective of this study is to prospectively document the efficacy and clinical outcomes of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD device or the standard monopolar electrocautery knife.

详细描述

Endoscopic submucosal dissection (ESD) is a novel technique for the removal of esophageal lesions or polyps with high-risk features. ESD is minimally invasive and allows the removal of esophageal polyps without resorting to morbid surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.

Traditionally, knifes utilizing monopolar current such as dual knife or hybrid knife were the preferred tools for endoscopic submucosal dissection. These knifes allows accurate dissection and excellent hemostasis. However, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. Post coagulation syndrome present with pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. In addition, for large esophageal lesions, stricturing can occur after resection due to significant scar formation induced by large amounts of energy. Almost all patients with 60% of the esophageal circumference removed via monopolar knives, will develop an esophageal stricture at some point. These patients require serial esophageal dilations, and although easily managed, its development can be quite troublesome to the patient. Nevertheless, ESD is still the preferred modality for removal of these lesions, since it avoids the need for morbid surgery. Recently, a novel bipolar RFA knife were approved by FDA for the performance of ESD. The knife utilizes bipolar RFA current for submucosal dissection which can potentially expedite submucosal dissection and decrease the rates of post polypectomy syndrome and scar formation, by using significantly less energy. This bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.

Our tertiary referral center Baylor St Luke's Medical Center is a center of excellence for ESD procedure and the investigators have previously reported our Esophageal ESD experience using the monopolar current knife. The goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar RFA knife in esophageal endoscopic submucosal dissection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

The patient will not know which electrocautery tool will be used in their procedure.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is ≥ 18 years old
  • Patient is capable of providing informed consent
  • Patient is referred for ESD procedure of an esophageal neoplastic lesion

排除标准

  • Patient is < 18 years old
  • Patient refused and/or unable to provide consent
  • Patient is a pregnant woman
  • Patients with lesions removed with other techniques besides ESD (i.e. cap EMR) or a modified ESD technique

结局指标

主要结局

Speed of Endoscopic Submucosal Dissection

时间窗: Day 1 (procedure day)

The speed of endoscopic submucosal dissection as calculated by cm2/hour

次要结局

  • En-bloc resection achieved(Day 1 (procedure day))
  • R0 Resection achieved(1-3 days post-procedure)
  • Curative Resection achieved(1-3 days post-procedure)
  • Rate of esophageal stricturing post-procedure(1-3 days post-procedure)
  • Adverse events(1 month, 3 months, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salmaan Azam Jawaid, MD

Principal Investigator

Baylor College of Medicine

研究点 (2)

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