Clinical trial NCT05736705: Monopolar and Bipolar in Esophageal ESD
Official title: Randomized Controlled Trial Comparing Outcomes of Monopolar Current Cutting Knife and Bipolar RFA Knife in Esophageal Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophageal Neoplasm
Esophageal Polyp
Endoscopic Submucosal Dissection
Bipolar Electocautery
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with patients randomized into receiving either the standard of care monopolar electrocautery tool or bipolar electrocautery tool.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Speed of Endoscopic Submucosal Dissection
timeFrame: Day 1 (procedure day)
Secondary outcomes:
measure: En-bloc resection achieved
timeFrame: Day 1 (procedure day)
measure: R0 Resection achieved
timeFrame: 1-3 days post-procedure
measure: Curative Resection achieved
timeFrame: 1-3 days post-procedure
measure: Adverse events
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Rate of esophageal stricturing post-procedure
timeFrame: 1-3 days post-procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: