Monopolar and Bipolar in Esophageal ESD

NCT ID: NCT05736705

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2024-06-25

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.

Conditions

Esophageal Neoplasm; Esophageal Polyp; Endoscopic Submucosal Dissection; Bipolar Electocautery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Monopolar Electrocautery tool

Patients randomized into this group will receive the standard of care monopolar tool for their endoscopic submucosal dissection procedure.

Group Type: ACTIVE_COMPARATOR

Endoscopic Submucosal Dissection

Intervention Type: PROCEDURE

Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.

Bipolar Electrocautery tool

Patients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure.

Group Type: EXPERIMENTAL

Endoscopic Submucosal Dissection

Intervention Type: PROCEDURE

Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.

Bipolar electrocautery knife

Intervention Type: DEVICE

Participants randomized in this arm will have the removal of their esophageal lesion utilizing the bipolar electrocautery knife.

Interventions

Endoscopic Submucosal Dissection

Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.

Intervention Type: PROCEDURE

Bipolar electrocautery knife

Participants randomized in this arm will have the removal of their esophageal lesion utilizing the bipolar electrocautery knife.

Intervention Type: DEVICE

Other Intervention Names

ESD; Mucosal Resection; ESD; Mucosal Resection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Salmaan Azam Jawaid, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

H-52921

Identifier Type: -

Identifier Source: org_study_id