Monopolar Current Cutting Knife vs Bipolar RFA Knife

Study Overview
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Brief Summary
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This is a prospective, randomized trial that aims to study the efficacy and clinical outcomes of a novel Bipolar Knife vs. Monopolar Knives on patients who undergo endoscopic submucosal dissection (ESD) procedure at Baylor St. Luke's Medical Center.

Detailed Description
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Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to 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 abdominal pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. Recently, a novel bipolar Radiofrequency Ablation (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. Our tertiary referral center Baylor St Luke's Medical Center is center of excellence for ESD procedure and we have previously reported our ESD experience using specialized stability and traction device and monopolar current knife in 111 patients. The goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar RFA knife in colonic endoscopic submucosal dissection.

Official Title
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Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in Colonic Endoscopic Submucosal Dissection

Conditions
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Gastrointestinal Neoplasms

Intervention / Treatment
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* Procedure: Endoscopic Submucosal Dissection
* Procedure: Endoscopic Mucosal Resection


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 gastrointestinal neoplastic lesions 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 or a modified ESD technique (i.e., EMR or TEM) as defined in the Japan Gastroenterological Endoscopy Society (JGES) guidelines for endoscopic resection of lesions.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bipolar Knife<br>ESD procedure performed with a novel bipolar knife. | Procedure: Endoscopic Submucosal Dissection<br>* Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to 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.<br>* Other names: ESD;Procedure: Endoscopic Mucosal Resection<br>* Endoscopic mucosal resection (EMR) is a conventional endoscopic technique commonly used for the resection of superficial neoplastic lesions in the GI tract. EMR carries lower morbidity and mortality compared to surgery.<br>* Other names: EMR, Endoscopic resection;|
| Active Comparator: Monopolar Knife<br>ESD procedure performed with monopolar knives. | Procedure: Endoscopic Submucosal Dissection<br>* Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to 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.<br>* Other names: ESD;Procedure: Endoscopic Mucosal Resection<br>* Endoscopic mucosal resection (EMR) is a conventional endoscopic technique commonly used for the resection of superficial neoplastic lesions in the GI tract. EMR carries lower morbidity and mortality compared to surgery.<br>* Other names: EMR, Endoscopic resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | The speed of endoscopic submucosal dissection as calculated by cm2/hour | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | En-bloc, R0 and curative resection rates for each knife | Day 1, 4 weeks | 
| Procedural adverse event | Adverse events during the procedure: hemorrhage, perforation, etc. | Day 1 | 
| Immediate post-procedural adverse event | Abdominal pain after the procedure using Visual Analogue Scale from 1 to 10 | Up to 24 hours | 
| Delayed post-procedural adverse event | Post polypectomy syndrome in both groups up to one month after the procedure | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Submucosal Dissection