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Search / Trial NCT07041229

Comparison of Methods for Removing Large Benign Broad-based Epithelial Neoplasms of the Colon: ESD and EMR.

Launched by PIROGOV RUSSIAN NATIONAL RESEARCH MEDICAL UNIVERSITY · Jun 19, 2025

Trial Information

Current as of September 12, 2025

Enrolling by invitation

Keywords

Esd, Emr

ClinConnect Summary

This study is testing two endoscopic (inside-the-gut) methods to remove large, non-cancerous growths in the colon that are 20–60 mm wide and have a broad base. The researchers want to know which method—endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)—is better at removing the lesion in one piece when possible, how long the procedure takes, and how often people have complications during or after the procedure (like bleeding or perforation). They will also look at how often the lesion comes back over 6 to 12 months and whether adding a additional edge treatment after EMR helps prevent recurrence.

People eligible include adults aged 18–100 who have a single benign colon lesion 20–60 mm in size, with no signs that the lesion is invasive cancer. Key exclusions include multiple large lesions, evidence of cancer, inflammatory bowel disease, recent colon procedures, certain medical conditions or medications, and inability to consent. Participants are randomly assigned to EMR or ESD, with possible additional edge ablation in the EMR group. They’ll be watched closely during and after the procedure for complications and will have follow-up checks at 6 and 12 months to see if the growth has recurred, with tissue samples reviewed to confirm complete removal. The trial is based in Moscow, aims to enroll about 110 people, and results are not yet available.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient with benign non-invasive epithelial formations of the colon on a broad base (Is and II types), 20-60 mm in size
  • Age ≥ 18 years.
  • Signed informed voluntary consent for colonoscopy and removal of formations using the studied methods of EMR and ESD
  • Exclusion Criteria:
  • . More than one large epithelial lesion on a broad base
  • Colon lesion less than 20 mm and more than 60 mm
  • Recurrent lesion.
  • Reasonable suspicion of an invasive lesion (cancer), including one with submucosal invasion based on the results of preoperative assessment (NICE - 3; JNET - 3; Kudo - Vn).
  • Presence of widespread malignant tumour in any part of the colon.
  • Use of other methods of endoscopic lesion removal.
  • IBD.
  • Infectious disease requiring systemic therapy
  • Patient on haemodialysis
  • Uncorrectable coagulopathy (INR\> 1.5), inability to discontinue antithrombotic drugs.
  • Refusal to participate in the study. 12. General contraindications to endoscopic examination.

About Pirogov Russian National Research Medical University

Pirogov Russian National Research Medical University is a prestigious academic institution dedicated to advancing medical science and education in Russia. Renowned for its commitment to high-quality research and innovation, the university plays a pivotal role in clinical trials aimed at improving healthcare outcomes. With a multidisciplinary approach, it fosters collaboration among leading experts in various medical fields, ensuring the development of safe and effective therapeutic interventions. The institution is focused on translating research findings into clinical practice, thereby contributing significantly to the advancement of medical knowledge and patient care both nationally and internationally.

Locations

Moscow, Russian Federation

Patients applied

0 patients applied

Trial Officials

Evgeny Gorbachev

Study Chair

Pirogov Russian National Research Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported