Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
- Conditions
- Esophageal PolypEsophageal NeoplasmEndoscopic Submucosal DissectionBipolar Electrocautery
- Interventions
- Device: Speedboat™ Ultraslim
- Registration Number
- NCT06476678
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.
- Detailed Description
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 were the preferred tools for endoscopic submucosal dissection. These knifes allow 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 resulting from the tissue healing response to electrocautery. 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 was FDA approved for endoscopic submucosal dissection. The low voltage bipolar system allows for precise cutting of submucosa and muscle using substantially less energy, thereby limiting inadvertent remote thermal effects. Additionally, it allows aggressive coagulation of vessels without dissipation of large amounts of energy, thereby allowing more targeted therapy. Moreover, with the addition of an integrated injection needle, the knife now allows injection, safe cutting and coagulation in one device, potentially supporting more efficient dissection. Ultimately, due to less thermal effect on surrounding tissue, the bipolar knife may allow for removal of large esophageal lesions without causing major esophageal stricturing.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
-
Patient is >18 years of age
-
Patient can provide informed consent
-
Patient is referred for resection of precancerous lesions meeting the following criteria:
- Mucosal based polyp
- Located gastroesophageal junction (GEJ) or proximal to GEJ
- No previous endoscopic resection attempted (EMR or ESD)
- Patients with International Normalized Ratio (INR) >1.5 or Platelets <50,000
- Lesions extending past GEJ
- Subepithelial lesions
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment arm Speedboat™ Ultraslim Patients who were deemed eligible and signed the consent will undergo the removal of their esophageal precancerous lesion utilizing the novel bipolar knife during their endoscopic submucosal dissection (ESD).
- Primary Outcome Measures
Name Time Method Technical success Day 1 (procedure day) Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife
- Secondary Outcome Measures
Name Time Method Rate of muscle injury score During Procedure As calculated by the Sydney Classification of Deep Mural Injury ranging from Type 0 - Type V with Type V as the most severe score.
Change in post-procedural pain score 24 hours, 2 weeks, and 4 weeks As calculated by the visual analog pain scale to measure patient pain ranging from 0-10 with 10 being the most pain.
Rate of esophageal stricturing Assessed at any follow-up post-procedure endoscopies up to 6 months Calculated by number of documented occurrences post-procedure for subjects
Degree of scar formation Assessed at any follow-up post-procedure endoscopies up to 6 months Scar formation that occurs in response to electrocautery
Cost of dissection During Procedure As calculated upon review of devices used during dissection procedure
Speed of Endoscopic Submucosal Dissection During Procedure The speed of endoscopic submucosal dissection as calculated by cm\^2/hour
Number of instruments used During Procedure Logging the variable equipment utilized during the procedure
Rate of post-electrocautery syndrome 24 hours, 2 weeks, and 4 weeks Define as post-procedure abdominal pain, fevers, leukocytosis
Trial Locations
- Locations (1)
Baylor College of Medicine
🇺🇸Houston, Texas, United States