Endoscopic Mucosal Resection With Circumferential Incision
Conditions
Keywords
C-EMR, Endoscopic treatment, colorectal neoplasm, circumferential incision
Brief summary
This is a prospective randomized trial to improve the results of treatment of patients with colorectal neoplasms.
Detailed description
Generally, endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are the methods of choice for the removal of benign and early malignant neoplasms of the colon. However, there are certain difficulties in terms of the EMR technique - this is an increase in the frequency of fragmentation with a lesion size of more than 20 mm, which in turn increases the risk of recurrence; with regard to ESD technique, this is a long procedure time; high incidence of complications; significant time required for teaching the technique; technical difficulties. In this regard, it is worth paying attention to the method of endoscopic mucosal resection with circumferential mucosal incision (C-EMR). This method deserves interest due to the fact that it allows more often to perform en-block resections in comparison with the classical method of endoscopic mucosal resection (EMR - endoscopic mucosal resection); technically easier to do; takes a short procedure time.
Interventions
PROCEDUREEndoscopic mucosal resection with circumferential incision
The endoscope will be passed into the intestine to the site of the tumor. Using an endoscopic needle, the solution will be injected into the submucosa to create a pillow. Then, using an endoscopic knife (insulated tip knife, Olympus or Water Jet, Erbe), a circular incision will be made around the lesion with an offset of 2-5 mm. Then there will be a one-stage electro excision of the neoplasm using an endoscopic loop.
PROCEDUREEndoscopic submucosal dissection
The endoscope will be passed into the intestine to the site of the tumor. Using an endoscopic needle, the solution will be injected into the submucosa to create a pillow. Then, using an endoscopic knife (insulated tip knife, Olympus or Water Jet, Erbe), a circular incision is made around the lesion. Then dissection will be performed in the submucosal layer.
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, single-center, randomized, non inferiority
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients with benign colon neoplasms without signs of deep invasion (I, II, IIIL and IV type according to Kudo, I and II type according to Sano) * the size of the neoplasm is from 20 mm to 30 mm * patient for treatment
Exclusion criteria
* unsatisfactory tumor lifting * refusal of the patient from research at any stage of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | 14 day |
Secondary
| Measure | Time frame |
|---|---|
| En-block resesction rate | 14 day |
| conversion rate | 1 day |
| intervention time | 1 day |
| intra- and postoperative complications rate | 30 day |
Countries
Russia
Outcome results
None listed