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

Recruiting

• Conditions: Adenoma Colon Polyp

• Registration Number: NCT06476145
• Lead Sponsor: AdventHealth

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-08
• Status Verified: 2024-06
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-12-08
• Study Completion: 2026-03-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adenoma Reocurrance	3 - 12 (+/- 6 months)	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of overall severe adverse events: Postpolypectomy Syndrome	Index procedure, 1 - 3 days post, 30 days.	Abdominal pain severe enough to warrant emergency room or hospital admission in the presence of fever, leukocytosis, peritoneal inflammation in the absence of frank perforation on CT, and/or required treatment with antibiotics.
Comparison of MM vs STSC procedure time	Index procedure visit	MM procedure time is defined as that required to complete placing cautery marks around the lesion prior to resection. STSC time is defined as that required to complete margin ablation around the entire resection margin.
Incidence of overall severe adverse events: Bleeding	Index procedure, 1 - 3 days post, 30 days.	Severe bleeding (immediate or delayed): defined as the need for hospitalization, transfusion, repeat endoscopy, surgery or interventional radiology. Immediate complication is defined as an event at the time of ESD resection or immediately following colonoscopy (before patient has left the endoscopy unit or during the immediate post-procedural care). A delayed (post-procedure) bleed is defined as an event that occurs after the patient has left the endoscopy unit and within 30 days following the procedure
EMR procedure time	During procedure visit	Time from submucosal injection to completion of resection, including the time required to treat any intraprocedural adverse event, but not including time on prophylactic endoscopic closure.
Incidence of overall severe adverse events: Perforation	Index procedure, 1 - 3 days post, 30 days.	Defined as complete hole, or full-thickness resection of the muscularis propria (Sidney classification of deep mural injury type IV or V).

Trial Locations

Locations (1)

AdventHealth; 🇺🇸 Orlando, Florida, United States