Monopolar Current Cutting Knife vs Bipolar RFA Knife

NCT04919824 | Active Not Recruiting

• 1 other identifier: H-49483
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastrointestinal Neoplasms

Keywords

Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• Procedure time

  The speed of endoscopic submucosal dissection as calculated by cm2/hour

  Day 1

Secondary Outcomes (4)

• Technical success rate

  Day 1, 4 weeks

• Procedural adverse event

  Day 1

• Immediate post-procedural adverse event

  Up to 24 hours

• Delayed post-procedural adverse event

  4 weeks

Study Arms (2)

Bipolar Knife

EXPERIMENTAL

ESD procedure performed with a novel bipolar knife.

Procedure: Endoscopic Submucosal Dissection; Procedure: Endoscopic Mucosal Resection

Monopolar Knife

ACTIVE COMPARATOR

ESD procedure performed with monopolar knives.

Procedure: Endoscopic Submucosal Dissection; Procedure: Endoscopic Mucosal Resection

Interventions

Endoscopic Submucosal Dissection PROCEDURE

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.

Also known as: ESD

Bipolar Knife; Monopolar Knife

Endoscopic Mucosal Resection PROCEDURE

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.

Also known as: EMR, Endoscopic resection

Bipolar Knife; Monopolar Knife

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years old
• Patient is capable of providing informed consent
• Patient is referred for ESD procedure of gastrointestinal neoplastic lesions

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Baylor St. Lukes Medical Center (BSLMC)

Houston, Texas, 77030, United States

Location

Related Publications (8)

• Takeuchi Y, Uedo N, Ishihara R, Iishi H, Kizu T, Inoue T, Chatani R, Hanaoka N, Taniguchi T, Kawada N, Higashino K, Shimokawa T, Tatsuta M. Efficacy of an endo-knife with a water-jet function (Flushknife) for endoscopic submucosal dissection of superficial colorectal neoplasms. Am J Gastroenterol. 2010 Feb;105(2):314-22. doi: 10.1038/ajg.2009.547. Epub 2009 Sep 22.

  PMID: 19773749 BACKGROUND

• Hong MJ, Kim JH, Lee SY, Sung IK, Park HS, Shim CS. Prevalence and clinical features of coagulation syndrome after endoscopic submucosal dissection for colorectal neoplasms. Dig Dis Sci. 2015 Jan;60(1):211-6. doi: 10.1007/s10620-014-3484-9. Epub 2014 Dec 13.

  PMID: 25502119 BACKGROUND

• Jung D, Youn YH, Jahng J, Kim JH, Park H. Risk of electrocoagulation syndrome after endoscopic submucosal dissection in the colon and rectum. Endoscopy. 2013 Sep;45(9):714-7. doi: 10.1055/s-0033-1344555. Epub 2013 Aug 29.

  PMID: 23990482 BACKGROUND

• Tsiamoulos ZP, Sebastian J, Bagla N, Hancock C, Saunders BP. A new approach to endoscopic submucosal tunneling dissection: the "Speedboat-RS2" device. Endoscopy. 2019 Jul;51(7):E185-E186. doi: 10.1055/a-0875-3352. Epub 2019 Apr 12. No abstract available.

  PMID: 30978741 BACKGROUND

• Ismail MS, Bahdi F, Mercado MO, Habazi R, Alexander A, Prabhu S, John S, Kovvali C, Othman MO. ESD with double-balloon endoluminal intervention platform versus standard ESD for management of colon polyps. Endosc Int Open. 2020 Oct;8(10):E1273-E1279. doi: 10.1055/a-1226-6372. Epub 2020 Sep 22.

  PMID: 33015328 BACKGROUND

• Cao Y, Liao C, Tan A, Gao Y, Mo Z, Gao F. Meta-analysis of endoscopic submucosal dissection versus endoscopic mucosal resection for tumors of the gastrointestinal tract. Endoscopy. 2009 Sep;41(9):751-7. doi: 10.1055/s-0029-1215053. Epub 2009 Aug 19.

  PMID: 19693750 BACKGROUND

• 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.

  PMID: 32005163 BACKGROUND

• Williams CB, de Peyer RC. Bipolar snare polypectomy--a safer technique for electrocoagulation of large polyp stalks. Endoscopy. 1979 Feb;11(1):47-50. doi: 10.1055/s-0028-1098324.

  PMID: 428352 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 9, 2021
• Study Start: January 25, 2022
• Primary Completion: May 30, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)