This study will investigate which resection technique (Endoscopic Mucosal Resection (EMR), cold EMR, or underwater EMR) leads to lower recurrence rates and less adverse events in patients with colorectal polyps (10-20mm).
Endoscopic resection of colorectal polyps has previously been demonstrated to lower the incidence of colorectal cancer, a major cause of cancer-related mortality globally. By disrupting the progression of adenomas into carcinomas, polypectomy is essential in effectively lowering colorectal cancer mortality. There is currently a surplus of high-quality research on the best ways to remove large polyps (\>20mm). For colorectal polyps of 10 to 20 mm, however, the best endoscopic resection method is unknown. Due to the lack of a standard polypectomy technique for the complete removal of medium-sized colorectal polyps, clinicians use a variety of methods according to their preferences and local resources. The historic gold standard of treatment for resecting polyps greater than 10 mm is hot endoscopic mucosal resection (EMR). The term "hot" refers to the use of electrocautery to cut through dense mucosal tissue, ablate remaining marginal dysplastic tissue, and prevent rapid bleeding through thermal vascular coagulation. However, adverse events such as perforation, prolonged bleeding, and post-polypectomy syndrome are all linked to electrocautery-induced damage. In contrast, cold snare polypectomy (CSP) and cold electrocautery minimal resection with injection (C-EMR-I) are alternative well-established techniques for the removal of polyps smaller than 10 mm, demonstrated to be associated with less delayed adverse effects than EMR. Underwater EMR (U-EMR), a novel technique developed in the last decade wherein water is instilled into the colon, allowing for submucosal fat to rise, elevating the lesion, and allowing mucosal resection in the absence of submucosal injectate. U-EMR may achieving higher en bloc resection rates, R0 resection rates, and lower recurrence rates. There are no specific recommendations for EMR of medium-sized polyps from gastroenterological and endoscopic societies globally. The aim of this randomized control study is to compare the polyp recurrence rates and adverse events between cold snare EMR (C-EMR), hot EMR (H-EMR) and underwater EMR (U-EMR) for colorectal polyps in the size of 10-20mm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.
C-EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.
U-EMR will be used to resect an eligible medium-sized polyp found in patients from this arm.
Polyp Recurrence Rate
The primary outcome of this study is the polyp recurrence rate at follow-up between the three techniques. Recurrence is evaluated 6 to 12 months after initial colonoscopy with endoscopic evaluation and biopsy of the scar. If adenoma is suspected under high-definition white light and/or electronic/conventional chromoendoscopy, the operator will remove it by snare or bioptic forceps. Final histology will be used to define recurrence rate.
Time frame: Polyp recurrence rate will be determined during the follow-up procedure performed 6-12 months after the initial colonoscopy.
Adverse Events
The secondary outcomes include the number of adverse events and time spent performing the resection technique. Adverse events are defined according to the ASGE lexicon for endoscopic AEs. Major adverse events, such as bleeding and perforation will be evaluated. Procedure-related bleeding is defined as hematochezia and/or melena requiring follow-up endoscopy for hemostasis or transfusion. Perforation is endoscopically diagnosed as a visible hole in the colon wall during the procedure or the presence of free air on abdominal imaging after the resection. The ASGE lexicon will be used for detailed definition and timing of AEs.
Time frame: AEs will be evaluated in both the initial and follow-up procedures. The follow-up procedure will be performed 6-12 months after the initial colonoscopy. Relevant AEs that occur during the procedure and within one day post-procedure will be recorded.
Procedural time
Amount of time it takes to complete the colonoscopy (cecal intubation time and withdrawal time), and the amount of time taken to perform the resection technique. U-EMR start when the perimeter of the lesion is identified, and the device is fully inserted. C-EMR and EMR start at the time of injection. All techniques are considered finished when all lesion pieces are retrieved.
Time frame: Completion times will be recorded at the time of procedure for both initial and follow-up colonoscopies (performed 6-12 months after the initial procedure). The time to complete the resection technique will be recorded during the first colonoscopy.
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