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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04919824
Other study ID # H-49483
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 25, 2022
Est. completion date December 30, 2024

Study information

Verified date September 2023
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 30, 2024
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopic 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.
Endoscopic 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.

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas
United States Baylor St. Lukes Medical Center (BSLMC) Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Procedure time The speed of endoscopic submucosal dissection as calculated by cm2/hour Day 1
Secondary Technical success rate En-bloc, R0 and curative resection rates for each knife Day 1, 4 weeks
Secondary Procedural adverse event Adverse events during the procedure: hemorrhage, perforation, etc. Day 1
Secondary Immediate post-procedural adverse event Abdominal pain after the procedure using Visual Analogue Scale from 1 to 10 Up to 24 hours
Secondary Delayed post-procedural adverse event Post polypectomy syndrome in both groups up to one month after the procedure 4 weeks
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