Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation

Colon Polyp Clinical Trial

Official title:

Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063280
• Other study ID #: 19-00807
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: NYU Langone Health
• Contact: Sofia Yuen
• Phone: 646-501-2465
• Email: sofia.yuen[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multi-center randomized controlled trial in only 24 patients showed a significant reduction of the recurrence rate by treatment of the normal appearing perimeter of the EMR defect using the argon plasma coagulator (2). A recent non-randomized trial suggested a substantial reduction by treatment of the perimeter with the snare tip in the soft coagulation mode (3).

Description:

The previous study using STSC was a non-randomized trial. In this trial investigators hope to provide definitive evidence regarding the efficacy of APC and STSC vs control. It is hypothesized that Argon Plasma Coagulation (APC) or Snare Tip Soft Coagulation (STSC) treatment of the perimeter of the Endoscopic mucosal resection (EMR) defect will reduce the recurrence rate of adenomas when compared to our control of no treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 345
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 99 Years

Eligibility

Inclusion Criteria:

• Ability to provide informed consent

• Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion

Exclusion Criteria:

• Pedunculated lesions

• Inflammatory bowel disease

• Inability to provide informed consent

• Lesions less than 15mm in largest dimension

Related Conditions & MeSH terms

• Adenoma
• Colon Polyp
• Recurrence

Intervention

Procedure:
• Snare Tip Soft Coagulation (STSC)
Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5)
• Argon Plasma Coagulation (APC)
APC (preferred settings) of the perimeter of the EMR site

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of adenomas	the recurrence rate of adenomas at the site of any qualifying, previously resected lesions at the 6-month follow-up colonoscopy.	24 Months
Secondary	Time	During the colonoscopy the treatment time will be recorded as the time, after initial polyp resection, that the randomized treatment instrument comes into view until before clips are applied	1 Day
Secondary	Number of complications for each randomization arm	Complications will be assessed during the follow-up call simply by asking the patients if they experienced any adverse events.	30 Days