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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdventHealth

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pedunculated polyps

Inflammatory bowel disease

Inability to provide informed consent

Lesions < 20 mm in size (largest dimension)

Trial population

Primary Care Clinic

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

342 Participants
are grouped into 2 trial groups
Group A: EMR-MM
Group B: EMR-STSC

Trial outcomes

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.

Time frame
3 - 12 (+/- 6 months)

Secondary outcomes

1

EMR procedure time

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.

Time frame
During procedure visit
2

Comparison of MM vs STSC procedure time

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.

Time frame
Index procedure visit
3

Incidence of overall severe adverse events: Bleeding

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

Time frame
Index procedure, 1 - 3 days post, 30 days.
4

Incidence of overall severe adverse events: Perforation

Defined as complete hole, or full-thickness resection of the muscularis propria (Sidney classification of deep mural injury type IV or V).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth

Lead sponsor

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