Gastrointestinal Neoplasms
Conditions
Keywords
Endoscopic Submucosal Dissection
Brief summary
This is a prospective, randomized trial that aims to study the efficacy and clinical outcomes of a novel Bipolar Knife vs. Monopolar Knives on patients who undergo endoscopic submucosal dissection (ESD) procedure at Baylor St. Luke's Medical Center.
Detailed description
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to 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 abdominal pain, fever and leukocytosis and requires supportive treatment with IV fluid and antibiotics. Recently, a novel bipolar Radiofrequency Ablation (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. Our tertiary referral center Baylor St Luke's Medical Center is center of excellence for ESD procedure and we have previously reported our ESD experience using specialized stability and traction device and monopolar current knife in 111 patients. The goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar RFA knife in colonic endoscopic submucosal dissection.
Interventions
PROCEDUREEndoscopic Submucosal Dissection
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to 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.
PROCEDUREEndoscopic Mucosal Resection
Endoscopic mucosal resection (EMR) is a conventional endoscopic technique commonly used for the resection of superficial neoplastic lesions in the GI tract. EMR carries lower morbidity and mortality compared to surgery.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is ≥ 18 years old 2. Patient is capable of providing informed consent 3. Patient is referred for ESD procedure of gastrointestinal neoplastic lesions
Exclusion criteria
1. Patient is \< 18 years old 2. Patient refused and/or unable to provide consent 3. Patient is a pregnant woman 4. Patients with lesions removed with other techniques besides ESD or a modified ESD technique (i.e., EMR or TEM) as defined in the Japan Gastroenterological Endoscopy Society (JGES) guidelines for endoscopic resection of lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | Day 1 | The speed of endoscopic submucosal dissection as calculated by cm2/hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | Day 1, 4 weeks | En-bloc, R0 and curative resection rates for each knife |
| Procedural adverse event | Day 1 | Adverse events during the procedure: hemorrhage, perforation, etc. |
| Immediate post-procedural adverse event | Up to 24 hours | Abdominal pain after the procedure using Visual Analogue Scale from 1 to 10 |
| Delayed post-procedural adverse event | 4 weeks | Post polypectomy syndrome in both groups up to one month after the procedure |
Countries
United States
Outcome results
None listed