Monopolar and Bipolar in Esophageal ESD

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Esophageal Neoplasm; Endoscopic Submucosal Dissection; Esophageal Polyp; Bipolar Electocautery
• Intervention / Treatment: Procedure: Endoscopic Submucosal Dissection; Device: Bipolar 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: H-52921

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes