Bipolar Electocautery, Endoscopic Submucosal Dissection, Esophageal Neoplasm, Esophageal Polyp
Conditions
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.
Interventions
PROCEDUREEndoscopic Submucosal Dissection
Participants randomized in this arm will have the removal of their esophageal lesion utilizing the monopolar electrocautery knife.
DEVICEBipolar electrocautery knife
Participants randomized in this arm will have the removal of their esophageal lesion utilizing the bipolar electrocautery knife.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
The patient will not know which electrocautery tool will be used in their procedure.
Intervention model description
Two groups with patients randomized into receiving either the standard of care monopolar electrocautery tool or bipolar electrocautery tool.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speed of Endoscopic Submucosal Dissection | Day 1 (procedure day) | The speed of endoscopic submucosal dissection as calculated by cm2/hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Adverse events | 1 month, 3 months, 6 months, 12 months | Collection of unanticipated medical occurrences within a 12 month time frame |
| 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. |
Countries
United States
Outcome results
None listed