Clinical trial · Interventional
Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions
Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions.Randomized and Multicentric Clinical Trial
NCT04418843CI-TRIAL-00070010completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 homogeneous colorectal lesions \>20mm
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma Colon | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Serrated Adenoma | Traditional Serrated Adenoma | ALIAS | 0.90 |
| Serrated Polyp | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold Snare Endoscopic Mucosal Resection | Procedure | — | UNRESOLVED |
| Standard Endoscopic Mucosal Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard Endoscopic Mucosal Resection
- description
- Standard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (\>20 mm)
- interventionNames
- Procedure: Standard Endoscopic Mucosal Resection
- type
- EXPERIMENTAL
- label
- Cold Snare Endoscopic Mucosal Resection
- description
- Cold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (\>20 mm)
- interventionNames
- Procedure: Cold Snare Endoscopic Mucosal Resection
Primary outcomes (1)
- measure
- Complete resection of the lesion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * .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
References
Publications (16)
- BACKGROUNDThoguluva Chandrasekar V, Spadaccini M, Aziz M, Maselli R, Hassan S, Fuccio L, Duvvuri A, Frazzoni L, Desai M, Fugazza A, Jegadeesan R, Colombo M, Dasari CS, Hassan C, Sharma P, Repici A. Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis. Gastrointest Endosc. 2019 May;89(5):929-936.e3. doi: 10.1016/j.gie.2018.12.022. Epub 2019 Jan 9. PMID 30639542
- BACKGROUNDHoriuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11. PMID 24125514
- BACKGROUNDTakeuchi Y, Yamashina T, Matsuura N, Ito T, Fujii M, Nagai K, Matsui F, Akasaka T, Hanaoka N, Higashino K, Iishi H, Ishihara R, Thorlacius H, Uedo N. Feasibility of cold snare polypectomy in Japan: A pilot study. World J Gastrointest Endosc. 2015 Nov 25;7(17):1250-6. doi: 10.4253/wjge.v7.i17.1250. PMID 26634041
- BACKGROUNDAslan F, Camci M, Alper E, Akpinar Z, Arabul M, Celik M, Unsal B. Cold snare polypectomy versus hot snare polypectomy in endoscopic treatment of small polyps. Turk J Gastroenterol. 2014 Jun;25(3):279-83. doi: 10.5152/tjg.2014.5085. PMID 25141316
- BACKGROUNDTate DJ, Awadie H, Bahin FF, Desomer L, Lee R, Heitman SJ, Goodrick K, Bourke MJ. Wide-field piecemeal cold snare polypectomy of large sessile serrated polyps without a submucosal injection is safe. Endoscopy. 2018 Mar;50(3):248-252. doi: 10.1055/s-0043-121219. Epub 2017 Nov 23. PMID 29169195
- BACKGROUNDHirose R, Yoshida N, Murakami T, Ogiso K, Inada Y, Dohi O, Okayama T, Kamada K, Uchiyama K, Handa O, Ishikawa T, Konishi H, Naito Y, Fujita Y, Kishimoto M, Yanagisawa A, Itoh Y. Histopathological analysis of cold snare polypectomy and its indication for colorectal polyps 10-14 mm in diameter. Dig Endosc. 2017 Jul;29(5):594-601. doi: 10.1111/den.12825. Epub 2017 May 17.