Monopolar and Bipolar in Esophageal ESD

Not Applicable

Withdrawn

• Conditions: Esophageal Polyp; Endoscopic Submucosal Dissection; Esophageal Neoplasm; Bipolar Electocautery
• Interventions: Procedure: Endoscopic Submucosal Dissection; Device: Bipolar electrocautery knife

• Registration Number: NCT05736705
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-01-23
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-21
• Status Verified: 2024-06
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar Electrocautery tool	Endoscopic Submucosal Dissection	Patients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure.
Monopolar Electrocautery tool	Endoscopic Submucosal Dissection	Patients randomized into this group will receive the standard of care monopolar tool for their endoscopic submucosal dissection procedure.
Bipolar Electrocautery tool	Bipolar electrocautery knife	Patients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure.

Primary Outcome Measures

Name	Time	Method
Speed of Endoscopic Submucosal Dissection	Day 1 (procedure day)	The speed of endoscopic submucosal dissection as calculated by cm2/hour

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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