Monopolar and Bipolar in Esophageal ESD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Esophageal Neoplasm, Esophageal Polyp, Endoscopic Submucosal Dissection, Bipolar Electocautery

Intervention / Treatment
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* Procedure: Endoscopic Submucosal Dissection
* Device: Bipolar electrocautery knife


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 years old Patient is capable of providing informed consent Patient is referred for ESD procedure of an esophageal neoplastic lesion Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups with patients randomized into receiving either the standard of care monopolar electrocautery tool or bipolar electrocautery tool.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monopolar Electrocautery tool<br>Patients randomized into this group will receive the standard of care monopolar tool for their endoscopic submucosal dissection procedure. | Procedure: Endoscopic Submucosal Dissection<br>* Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.<br>* Other names: Mucosal Resection;|
| Experimental: Bipolar Electrocautery tool<br>Patients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure. | Procedure: Endoscopic Submucosal Dissection<br>* Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.<br>* Other names: Mucosal Resection;Device: Bipolar electrocautery knife<br>* Participants randomized in this arm will have the removal of their esophageal lesion utilizing the bipolar electrocautery knife.<br>* Other names: Mucosal Resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of Endoscopic Submucosal Dissection | The speed of endoscopic submucosal dissection as calculated by cm2/hour | Day 1 (procedure day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En-bloc resection achieved | Endoscopist removal of entire tissue specimen as a whole | Day 1 (procedure day) | 
| R0 Resection achieved | Margins of tissue specimen deemed by pathologist as completely excised (R0) | 1-3 days post-procedure | 
| Curative Resection achieved | Complete removal of diseased tissue by endoscopic submucosal dissection procedure | 1-3 days post-procedure | 
| Adverse events | Collection of unanticipated medical occurrences within a 12 month time frame | 1 month, 3 months, 6 months, 12 months | 
| Rate of esophageal stricturing post-procedure | Calculated as a percentage of patients reported with stricturing with 1-3 days following procedure. | 1-3 days post-procedure |