Status:
COMPLETED
Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions
Lead Sponsor:
Oscar Nogales
Collaborating Sponsors:
Spanish Society of Digestive Endoscopy
Conditions:
Adenoma Colon
Serrated Polyp
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study compares the effectiveness in complete resection (absence of recurrence at 6 months) the two different techniques for performing endoscopic mucosal resection (EMR) of nonpedunculated homoge...
Detailed Description
Colonoscopy is the reference diagnostic test for the study of colon diseases. This procedure also allows the realization of endoscopic therapeutics techniques; thus, endoscopic mucosal resection (EMR)...
Eligibility Criteria
Inclusion
- Patients of age \> 18 years undergoing a colonoscopy for any reason of request and who do not meet exclusion criteria.
- Nonpedunculated homogeneous colorectal lesions type LST ( Paris 0-IIa morphology) and serrated lesions larger than 20 mm without endoscopic data of malignancy: NICE 1 pattern +/- NICE 2 component ( serrated lesions) or NICE2 pattern/JNET 2A (adenomas) and therefore subsidiaries of RME. Randomization will be performed per patient, not for colorectal lesions
- Signature of informed consent of endoscopic exploration
Exclusion
- .No signature of informed consent prior to the study procedure.
- Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations (BSG and ESGE guidelines)
- Patients with severe thrombopenia/ coagulopathy (Platelets \< 50,000/INR \> 1.5) not corrected prior to procedure (plasma or platelet transfusion)
- Patients not candidates for endoscopic resection of colorectal lesions by comorbidities.
- Pregnant.
- Patients with inflammatory bowel disease (IBD)
- Urgent colonoscopy.
- Poor preparation (BBPS \<2 in the colon segment where the lesion is located)
- Laterally spreading tumors (LST) lesions with non-homogeneous morphology including: sessile polyps (0-Is), pedunculated (0-Ip) and LST lesions with depressed or excavated components (Paris 0-IIc or Paris 0-III), LST granular nodular mixed, LST-G with whole nodular type. In case of doubt depressed component (Paris 0-IIc) or histological borderline lesion (JNET2B), will be excluded from the study.
- Histological prediction of deep invasive or non-subsidiary to endoscopic mucosal resection lesion as a treatment of choice: NICE 3 pattern by inspection with NBI or Kudo V pattern in traditional/electronic chromoendoscopy or Sano IIIA/IIIB pattern
- Endoscopic resection of post-EMR scar level relapses
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT04418843
Start Date
June 8 2020
End Date
March 31 2023
Last Update
September 28 2023
Active Locations (1)
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1
Óscar Nogales Rincón
Madrid, Spain, 28007