NCT04418843

Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions

Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions.Randomized and Multicentric Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Oscar Nogales · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study compares the effectiveness in complete resection (absence of recurrence at 6 months) the two different techniques for performing endoscopic mucosal resection (EMR) of nonpedunculated homogeneous colorectal lesions \>20mm

Detailed description

Colonoscopy is the reference diagnostic test for the study of colon diseases. This procedure also allows the realization of endoscopic therapeutics techniques; thus, endoscopic mucosal resection (EMR) is an effective and safe therapy for the treatment of premalignant and early malignant colorectal lesions of the colon and its use is universal. Usually, colon lesions larger than 10 mm (or pedunculated of any size) require for resection the use of electrocoagulation current (or hot snare polypectomy) and thus is reflected in the most recent clinical practice guidelines (ESGE guidelines, for example). However, the risk of side adverse effects from the use of electrocoagulation is not insignificant and includes post-polypectomy bleeding, post-polypectomy syndrome, post-polypectomy fever and/or immediate or delayed perforation. This risk of complications is higher depending on the characteristics and size of colorectal lesions resected. On the other hand, currently in small lesions not pedunculated (\< 10 mm), it is recommended to use cold snare polypectomy according to ESGE clinical guidelines, as it has been seen in previous studies that this reduces complication rates without varying the effectiveness in resection. However, in lesions \> 10 mm the previous experience with cold snare resection is less, probably motivated by the possible drawbacks in terms of the possible difficulty of resection of thick tissue with cold snare and a possible increased intra-procedure hemorrhagic risk that can make it difficult to see the scar, with the possibility of leaving residual tissue. However, in recent years the accumulated evidence gathered in various studies and grouped in a recent systematic review suggests that endoscopic mucosal resection with cold snare (Cold-EMR) may be safer than electrocoagulation resection for both 10-19mm lesions and for lesions \>20 mm, associated with a lower rate of adverse effects with similar efficacy rates in terms of complete resection and adenomatous recurrence rate. Still, evidence for the treatment of nonpedunculated lesions \>20 mm is relatively limited and is not based on randomized comparative studies with the standard EMR technique.

Conditions

• Adenoma Colon
• Serrated Polyp
• Serrated Adenoma
• Colorectal Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Standard Endoscopic Mucosal Resection	Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery
PROCEDURE	Cold Snare Endoscopic Mucosal Resection	Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery

Timeline

• Start date: 2020-06-08
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2020-06-05
• Last updated: 2023-09-28

Locations

1 site across 1 country: Spain