Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation

NCT06476145 | Recruiting

• 1 other identifier: 1880214
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)

Conditions

Adenoma Colon Polyp

Outcome Measures

Primary Outcomes (1)

• Adenoma Reocurrance

  During Screening Colonoscopy (SC) 1, between 3 -12 post initial procedure. The post-EMR site will be assessed and biopsied for histology to assess for recurrence of adenoma.

  3 - 12 (+/- 6 months)

Secondary Outcomes (5)

• EMR procedure time

  During procedure visit

• Comparison of MM vs STSC procedure time

  Index procedure visit

• Incidence of overall severe adverse events: Bleeding

  Index procedure, 1 - 3 days post, 30 days.

• Incidence of overall severe adverse events: Perforation

  Index procedure, 1 - 3 days post, 30 days.

• Incidence of overall severe adverse events: Postpolypectomy Syndrome

  Index procedure, 1 - 3 days post, 30 days.

Study Arms (2)

EMR-MM

Mucosal markings are placed clearly outside the visible margin of the lesion (polyp) by placing superficial cautery marks with the tip of the endoscopic snare approximately 3 mm away from the polyp margin. Successful marking with diathermy is established by visual identification of white circular "dots" around the entire outer border of the lesion. EMR is then performed as per standard technique as described above.

EMR-STSC

Endoscopic mucosal resection with thermal margin ablation (STSC) will be performed of the entire margin of the mucosal defect, by using a light touch with 1 to 2 mm of the exposed snare tip aiming to create a 2 to 3 mm rim of completely ablated tissue around the entire circumference of the resection defect. Successful STSC is confirmed by the presence of a rim of whitening mucosa around the defect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• Age 18 years or older
• Ability to provide informed consent
• Patient scheduled to undergo colonoscopy for the evaluation and removal of colon polyps
• Non-pedunculated polyps ≥ 20 mm size

You may not qualify if:

• Pedunculated polyps
• Inflammatory bowel disease
• Inability to provide informed consent
• Lesions \< 20 mm in size (largest dimension)
• Lesion involves the lips of the ileocecal valve, is located at the appendiceal orifice and/or is fully circumferential.
• Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy

Sponsors & Collaborators

• AdventHealth: lead
• Northwestern University: collaborator
• White River Junction Veterans Affairs Medical Center: collaborator
• Rush University: collaborator
• University Medical Centre Ljubljana: collaborator
• University of Kansas: collaborator
• Henry Ford Health System: collaborator
• Carilion Clinic: collaborator
• St. Paul's Hospital, Canada: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (1)

AdventHealth

Orlando, Florida, 32804, United States

RECRUITING

Related Publications (24)

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Study Officials

• Dennis Yang, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Paredes, RN

CONTACT

407-303-5503; Diana.Paredes@adventhealth.com

Petronio Martins, MHA

CONTACT

407-303-5503; Petronio.martins@adventhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 26, 2024
• Study Start: December 8, 2023
• Primary Completion: May 30, 2026
• Study Completion (Estimated): January 8, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Records will be kept a minimum of 7 years according to institutional policy. At the end of this time, study records will be disposed of in a secure manner. Electronic data will be deleted from the file it is in and the deleted from the trash folder.
• Access Criteria: All study records will be stored in a locked, research team offices. Only research personnel will have access to study data. Electronic data will be stored on a password encrypted file.

Locations

US (1)