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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bipolar Knife | Experimental | ESD procedure performed with a novel bipolar knife. |
|
| Monopolar Knife | Active Comparator | ESD procedure performed with monopolar knives. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | The speed of endoscopic submucosal dissection as calculated by cm2/hour | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | En-bloc, R0 and curative resection rates for each knife | Day 1, 4 weeks |
| Procedural adverse event | Adverse events during the procedure: hemorrhage, perforation, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States | ||
| Baylor St. Lukes Medical Center (BSLMC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19773749 | Background | 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. | |
| 25502119 |
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This is a randomized prospective single-center study.
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
| 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. |
|
|
| Day 1 |
| Immediate post-procedural adverse event | Abdominal pain after the procedure using Visual Analogue Scale from 1 to 10 | Up to 24 hours |
| Delayed post-procedural adverse event | Post polypectomy syndrome in both groups up to one month after the procedure | 4 weeks |
| Houston |
| Texas |
| 77030 |
| United States |
| 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. |
| 23990482 | 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. |
| 30978741 | 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. |
| 33015328 | 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. |
| 19693750 | 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. |
| 32005163 | 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. |
| 428352 | 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. |
| D005767 |
| Gastrointestinal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |