Monopolar Current Cutting Knife vs Bipolar RFA Knife

Not Applicable

Active, not recruiting

• Conditions: Gastrointestinal Neoplasms
• Interventions: Procedure: Endoscopic Submucosal Dissection; Procedure: Endoscopic Mucosal Resection

• Registration Number: NCT04919824
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-09
• Study Start: 2022-01-25
• Primary Completion: 2023-05-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patient is ≥ 18 years old
2. Patient is capable of providing informed consent
3. Patient is referred for ESD procedure of gastrointestinal neoplastic lesions

Exclusion Criteria

1. Patient is < 18 years old
2. Patient refused and/or unable to provide consent
3. Patient is a pregnant woman
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar Knife	Endoscopic Submucosal Dissection	ESD procedure performed with a novel bipolar knife.
Monopolar Knife	Endoscopic Mucosal Resection	ESD procedure performed with monopolar knives.
Monopolar Knife	Endoscopic Submucosal Dissection	ESD procedure performed with monopolar knives.
Bipolar Knife	Endoscopic Mucosal Resection	ESD procedure performed with a novel bipolar knife.

Primary Outcome Measures

Name	Time	Method
Procedure time	Day 1	The speed of endoscopic submucosal dissection as calculated by cm2/hour

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Baylor St. Lukes Medical Center (BSLMC); 🇺🇸 Houston, Texas, United States