Clinical trial NCT06476678: Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Official title: Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Neoplasm
Esophageal Polyp
Endoscopic Submucosal Dissection
Bipolar Electrocautery
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Creo Medical Limited
First posted: 2024-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing intended ESD of precancerous lesions will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approach individually for further discussion about the study and obtaining informed consent.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000
* Lesions extending past GEJ
* Subepithelial lesions

Primary outcomes:
measure: Technical success
timeFrame: Day 1 (procedure day)
Secondary outcomes:
measure: Speed of Endoscopic Submucosal Dissection
timeFrame: During Procedure
measure: Number of instruments used
timeFrame: During Procedure
measure: Rate of muscle injury score
timeFrame: During Procedure
measure: Rate of post-electrocautery syndrome
timeFrame: 24 hours, 2 weeks, and 4 weeks
measure: Change in post-procedural pain score
timeFrame: 24 hours, 2 weeks, and 4 weeks
measure: Rate of esophageal stricturing
timeFrame: Assessed at any follow-up post-procedure endoscopies up to 6 months
measure: Degree of scar formation
timeFrame: Assessed at any follow-up post-procedure endoscopies up to 6 months
measure: Cost of dissection
timeFrame: During Procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: