All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract. Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure. Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born "complication". A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milano, Italy
Macroscopically complete resection rate
Time frame: 6 Months
6-month recurrence rate;
Time frame: 6 Months
Rate of adverse events (according to the lexiconA ASGE).
Time frame: 6 Months
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