Precancerous Lesion of Colon
Conditions
Keywords
precancerous colorectal lesions
Brief summary
The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.
Detailed description
Large superficial colonic polyps are increasingly detected thanks to colorectal cancer screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps. Nevertheless, several adverse events affect ESD, especially in the colon. They could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs. Thus, preventing these adverse events is an important clinical and medico-economic objective. Endoscopic closure of post-ESD defects could reduce this risk. However, closing these large defects with conventional clips can be difficult, unsuccessful and prolong the duration of the whole procedure. A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time. Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure
Interventions
DEVICETTS suturing system
The use of TTS suturing system could allow a quick, complete endoscopic closure of colonic post-ESD defects, providing relevant clinical and medico-economic benefits.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips. Considering an α risk set at 5%, a power set at 80%, given an expected complete resection rate of 70% in the control group and of 95% in the experimental group, 33 patients in each group are required. Thus, the investigators will enroll 66 subjects
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient suffering from 30-60 mm colonic polyps with indication of ESD * Male or female patients aged \> 18 years' old * Patients able to fill in questionnaires written in Italian
Exclusion criteria
* Failure of endoscopic resection * Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn) * Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification) * Polyp inside the ileo-cecal valvula. * Rectal lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the proportion of complete closure between the two groups | Intra-procedural | To assess the proportion of complete closure, defined when opposite margins are drawn together without a persistent post-resection defect of more than 1 cm (pictures and/or videos) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of the closure procedure | up to 2 hours | To assess the closure procedure time, which is defined by duration between the beginning of assemblage of the suturing system and the end of the closure in the intervention group and between the opening of the bag of the first clip until the end of the closure in the control group.(pictures-videos) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of post-polypectomy syndrome | 1 week | To assess, it will compare the proportion between the 2 groups of post-polypectomy syndrome at Day 7 |
| Proportion of clinically significant delayed bleeding | 1 month | Compare and assess the proportion of clinically significant delayed bleeding at 1 month |
| Cost-effectiveness ratio | 1 month | To assess the cost-effectiveness ratio, estimated by dividing the difference in costs observed between the two strategies by the difference of effectiveness at 1 month. The effectiveness criterion being the closure time at 1 month |
| Length of hospitalization | up to 1 week | To compare the length of hospitalization defined as the number of procedural nights in the hospitals |
Contacts
Primary ContactAlessandro Repici, Prof.
Backup ContactAlessandro D'Aprano, Dr.
Outcome results
None listed