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| Name | Class |
|---|---|
| Creo Medical Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speedboatâ„¢ Ultraslim | Device | Use of Speedboatâ„¢ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife | Day 1 (procedure day) |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of Endoscopic Submucosal Dissection | The speed of endoscopic submucosal dissection as calculated by cm^2/hour | During Procedure |
| Number of instruments used | Logging the variable equipment utilized during the procedure |
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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:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salmaan A Jawaid, MD | Contact | 7137980950 | Salmaan.Jawaid@bcm.edu | |
| Haydee Rochits Cueto | Contact | 7137983606 | Haydee.RochitsCueto@bcm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| During Procedure |
| Rate of muscle injury score | As calculated by the Sydney Classification of Deep Mural Injury ranging from Type 0 - Type V with Type V as the most severe score. | During Procedure |
| Rate of post-electrocautery syndrome | Define as post-procedure abdominal pain, fevers, leukocytosis | 24 hours, 2 weeks, and 4 weeks |
| Change in post-procedural pain score | As calculated by the visual analog pain scale to measure patient pain ranging from 0-10 with 10 being the most pain. | 24 hours, 2 weeks, and 4 weeks |
| Rate of esophageal stricturing | Calculated by number of documented occurrences post-procedure for subjects | Assessed at any follow-up post-procedure endoscopies up to 6 months |
| Degree of scar formation | Scar formation that occurs in response to electrocautery | Assessed at any follow-up post-procedure endoscopies up to 6 months |
| Cost of dissection | As calculated upon review of devices used during dissection procedure | During Procedure |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |