Colonic Adenoma, Colonic Lesion, Colonic Neoplasms
Conditions
Brief summary
This randomized, multi-center trial aims to evaluate the advantages of underwater cold endoscopic mucosal resection technique (CS-EMR) in comparison to the conventional endoscopic mucosal resection technique (EMR) for laterally spreading colorectal lesions exceeding 20 mm in size. More precisely, our hypothesis posits that underwater cold EMR is non-inferior to conventional EMR in terms of recurrence rates, resection completeness and safety.
Detailed description
Endoscopic mucosal resection stands as one of the most commonly employed techniques for the removal of gastrointestinal lesions, particularly within the colon. Piece-meal endoscopic mucosal resection is the preferred approach for large colonic polyps without signs of deep infiltration. This method consists of the removal of lesions in multiple fragments. The conventional procedure starts with the initial submucosal infiltration of the submucosal layer using a physiological solution and methylene blue, forming a cushion that facilitates tissue transection with the assistance of a diathermic snare. The goal is to remove the lesions in larger fragments whenever possible. In contrast, the cold procedure, employs a specialized snare that enables tissue transection without the need for electrical current. This approach yields the same outcome as the conventional procedure but offers the advantage of reducing the risks associated with the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination.
Interventions
PROCEDURETraditional EMR
Conventional EMR with thermal ablation of resection margins: initial submucosal injection of saline and methylene blue and subsequent piecemeal resection with 10- or 15-mm diathermic snare with subsequent thermal ablation of resection margins with snare tip soft coagulation.Nevertheless, this technique is associated with the emergence of serious adverse events (SAEs), including delayed bleeding (PPB), electrocautery-induced post-polipectomy syndrome (PPS), and perforation(4).
PROCEDUREthe cold snare (CO), underwater technique (W), and the use of submucosal lift (L) in both study arms
The cold-EMR technique, as opposed to the conventional approach, employs a specialized snare that enables tissue transection without the need for electrical current, particularly in appropriately selected lesions. This approach yields the same efficacy outcome as the conventional procedure but offers the advantage of reducing the risks associated with polypectomy, which are often secondary to the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination. Furthermore, the use of underwater setting, as demonstrated for hot EMR, could improve the effectiveness of cold-EMR.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* all patients ≥ 18 years of age undergoing colonoscopy for any indication (screening, anaemia, surveillance) * patients who were able to give informed written consent.
Exclusion criteria
* lesions suspicious for submucosal invasion (e.g. Kudo V or Paris 0-IIa-IIc with nongranular surface). * lesions with large (\>10 mm) Paris 0-Is component that could compromise the nodular en-bloc resection and increase risk of submucosal invasion. * suspected sessile serrated adenomas (SSAs) according to traditional features such as adherent surface mucus, cloud-like surface, interruption of mucosal vessels, Kudo II-o pit pattern. * pedunculated polyps * active/quiescent colitis * patients with other lesions resected by hot snare during the same procedure. * rectal lesions * residual or recurrent adenoma after endoscopic mucosal resection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of resection defined as absence of residual/recurrence in SC1 and/or SC2 | at 6 and/or 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of intraprocedural adverse events such as bleeding or perforation | 2 years | Defined as any procedure-related complication that compromises the completeness of the procedure and/or results in unplanned hospitalization of the patient |
| Rate of delayed bleeding of the patient | 2 years | — |
| technical success | 2 years | defined by the complete resection of polyp |
| Rate of delayed perforation | 2 years | — |
| Avarage time of procedure and polyp resection time | 2 years | — |
| Rate of post-polipectomy syndrome | 2 years | — |
Contacts
Primary ContactAntonio Capogreco
Outcome results
None listed