Colonic Disease
Conditions
Brief summary
This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.
Interventions
PROCEDUREProcedure: Cold EMR + APC
* Initial submucosal injection of saline solution and methylene blue, followed by 'piece-meal' resection using a dedicated cold snare * Biopsy of the resection bed * Ablation of the defect using argon plasma coagulation (APC).
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection) * Lesions of 20 mm and larger. * All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern) * Patients who were able to provide written informed consent
Exclusion criteria
* Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface) * Lesions with a wide Paris 0-Is component (\>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare * Pedunculated polyps * Active/quiescent colitis * Rectal lesions * Residual or recurrent adenoma after endoscopic mucosal resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual | 1 day | Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample. |
| Recurrence | 1 year | The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of post-polipectomy syndrome | 1 day | The post-polipectomy syndrome is defined by the presence of fever or abdominal pain |
| Efficacy of procedure | 1 day | Complete resection of polyp |
| Time | 1 day | Average time of procedure and polyp resection time |
| perforation | 1 day | Rate of perforation and delayed perforation |
| Rate of delayed bleeding of the patient | 1 day | Delayed-bleeding, defined was defined as clinical evidence of bleeding (hematemesis, hematochezia or melena or a decrease of hemoglobin concentration \> 2g/dL, which required transfusion or endoscopic reintervention with hemostasis within 30 days of hospital discharge) |
Countries
Italy
Outcome results
None listed