Clinical trial NCT04919824: Monopolar Current Cutting Knife vs Bipolar RFA Knife
Official title: Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in Colonic Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastrointestinal Neoplasms
Keywords: Endoscopic Submucosal Dissection
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedure time
timeFrame: Day 1
Secondary outcomes:
measure: Technical success rate
timeFrame: Day 1, 4 weeks
measure: Procedural adverse event
timeFrame: Day 1
measure: Immediate post-procedural adverse event
timeFrame: Up to 24 hours
measure: Delayed post-procedural adverse event
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Baylor St. Lukes Medical Center (BSLMC)
state: Texas
Study officials:
References:
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citation: Shinmura K, Ikematsu H, Kojima M, Nakamura H, Osera S, Yoda Y, Hori K, Oono Y, Ochiai A, Yano T. Safety of endoscopic procedures with monopolar versus bipolar instruments in an ex vivo porcine model. BMC Gastroenterol. 2020 Jan 31;20(1):27. doi: 10.1186/s12876-020-1176-9.
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