Clinical Trial: Injection-Assisted Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Small Colorectal Polyps
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Comparison of Injection-Assisted Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Small (6-10mm) Colorectal Polyps
Brief Summary: Complete resection of neoplastic polyps is pivotal, as 8.8% to 50% of interval cancers may arise as a consequence of incomplete polypectomy. However, the ideal method to remove small colorectal polyps remains uncertain. The investigators designed a randomized controlled trial to assess whether injection-assisted cold snare polypectomy may be noninferior to EMR for the resection of small (6-10mm) colorectal polyps.
Detailed Summary:
Polypectomy is the basis of colorectal cancer prevention by interrupting the adenoma-to-carcinoma sequence. Most of the polypectomies are performed for diminutive (≤5mm) or small (6-10mm) colorectal lesions which represent >90% of the overall burden of resected polyps. Although the potential for neoplasia is usually size-dependent, recent evidence suggested that even diminutive and small polyps harbor a substantial risk of advanced neoplasia (in some series as high as 9-10%). Complete resection of neoplastic polyps is pivotal, as 8.8% to 50% of interval cancers may arise as a consequence of incomplete polypectomy. However, the ideal method to remove small colorectal polyps remains uncertain. Cold snare polypectomy has become standard technique allowing for comprehensive and safe resection of diminutive polyps, though significant incomplete resection rates have challenged the implementation of CSP for larger (in particular 8-10mm) polyps. Submucosal injection of a solution containing a staining dye could improve the outcome of cold snare polypectomy: a) lift of the lesion with submucosal chromoendoscopy could sharply delineate margins and facilitate capture and removal by using a cold snare, and b) formation of a submucosal cushion could minimize mechanical damage to the submucosal vessels, preventing the occurrence of immediate bleeding.
Use of electrocautery is believed to reduce the risk of incomplete resection, although it is less attractive from a safety standpoint due to the risk of complications including delayed bleeding, post-polypectomy syndrome and perforation. Injection of a submucosal solution in order to lift the lesion (injection-assisted endoscopic mucosal resection, EMR) facilitates "hot" resection of sessile or flat neoplasms and allows for a deeper resection margin as compared to conventional polypectomy, while it minimizes electrocaut
Sponsor: Benizelion General Hospital
Current Primary Outcome: Complete Resection Rate [ Time Frame: Two weeks after each polypectomy ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of complications (intraprocedural bleeding, postprocedural bleeding, post-polypectomy syndrome, perforation). [ Time Frame: Two weeks after each polypectomy ]
- Necessity of hemostasis (due to intraprocedural or postprocedural bleeding) [ Time Frame: Two weeks after each polypectomy ]
- Polyp retrieval rate [ Time Frame: Two weeks after each polypectomy ]
Original Secondary Outcome: Same as current
Information By: Benizelion General Hospital
Dates:
Date Received: February 3, 2016
Date Started: January 2016
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017
