Clinical trial · Interventional
Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas
Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas (>20 mm): the "CO.W.L." Prospective Randomized Trial
NCT06217250CI-TRIAL-00076232COWLunknownN/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 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Adenoma | Colon Adenoma | ALIAS | 0.90 |
| Colonic Lesion | — | UNRESOLVED | — |
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the cold snare ("CO"), underwater technique ("W"), and the use of submucosal lift ("L") in both study arms | Procedure | — | UNRESOLVED |
| Traditional EMR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional EMR
- description
- 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.
- interventionNames
- Procedure: Traditional EMR
- type
- EXPERIMENTAL
- label
- Underwater Cold EMR
- description
- Underwater Cold EMR (CS-EMR): after filling the lumen with water, initial submucosal injection of saline and methylene blue and subsequent piece-meal resection carried out with dedicated cold snare.
- interventionNames
- Procedure: the cold snare ("CO"), underwater technique ("W"), and the use of submucosal lift ("L") in both study arms
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDNishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969. PMID 24047059
- BACKGROUNDFerlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17. PMID 28212588
- BACKGROUNDSidhu M, Shahidi N, Gupta S, Desomer L, Vosko S, Arnout van Hattem W, Hourigan LF, Lee EYT, Moss A, Raftopoulos S, Heitman SJ, Williams SJ, Zanati S, Tate DJ, Burgess N, Bourke MJ. Outcomes of Thermal Ablation of the Mucosal Defect Margin After Endoscopic Mucosal Resection: A Prospective, International, Multicenter Trial of 1000 Large Nonpedunculated Colorectal Polyps. Gastroenterology. 2021 Jul;161(1):163-170.e3. doi: 10.1053/j.gastro.2021.03.044. Epub 2021 Mar 31. PMID 33798525
- BACKGROUNDRusso P, Barbeiro S, Awadie H, Libanio D, Dinis-Ribeiro M, Bourke M. Management of colorectal laterally spreading tumors: a systematic review and meta-analysis. Endosc Int Open. 2019 Feb;7(2):E239-E259. doi: 10.1055/a-0732-487. Epub 2019 Jan 30. PMID 30705959
- BACKGROUNDThoguluva Chandrasekar V, Aziz M, Patel HK, Sidhu N, Duvvuri A, Dasari C, Kennedy KF, Ashwath A, Spadaccini M, Desai M, Jegadeesan R, Sathyamurthy A, Vennalaganti P, Kohli D, Hassan C, Pellise M, Repici A, Sharma P, Bourke MJ. Efficacy and Safety of Endoscopic Resection of Sessile Serrated Polyps 10 mm or Larger: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2448-2455.e3. doi: 10.1016/j.cgh.2019.11.041. Epub 2019 Nov 29.