Cold Snare Endoscopic Mucosal Resection Of Duodenal Adenomas More Than Or Equal To 10 Mm: A Prospective Cohort Study
JG
John Guardiola
Principal Investigator
Status: Recruiting
Ages: 18 Years - 100 Years
Gender: All Genders
Phase: N/A
2 Locations
Brief Description
What is the purpose of this study?
The purpose of this study is to evaluate the safety and effectiveness of Cold Snare Endoscopic Mucosal Resection (CS-EMR) for the removal of non-cancerous polyps that are located in the small bowel (duodenal) and are 10 millimeters or greater in size.
The goal of this study is to determine if the use of CS-EMR, which is the technique used here at IU Health, is as effective and as safe as conventional Endoscopic Mucosal Resection (EMR) a technique used by other medical centers. The difference in the two methods is that EMR uses heat to remove the polyp, and CS-EMR does not. We hope the results of this study will help determine the best method to remove non-cancerous polyps in the lower bowel that are this size.
The goal of this study is to determine if the use of CS-EMR, which is the technique used here at IU Health, is as effective and as safe as conventional Endoscopic Mucosal Resection (EMR) a technique used by other medical centers. The difference in the two methods is that EMR uses heat to remove the polyp, and CS-EMR does not. We hope the results of this study will help determine the best method to remove non-cancerous polyps in the lower bowel that are this size.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects who are presenting to our practice for duodenal lesions will be identified via the endoscopy schedule and will be contacted by a member of the research team pre-procedure in the assessment area.
Detailed Description
What will happen during the study?
- Patients will undergo thier scheduled upper endoscopy.
- We will collect information about the procedure, including the appearance of the polyp and how it was removed.
- Photo images of the removal of polyp(s) will be taken, and the removal may also be recorded by video and used for study purposes.
- CS-EMR will be used to remove the polyp which is standard of care at IU Health. If the endoscopist determines EMR is the better method of removal for the polyp(s), we will document the reason why.
- Patients will receive a phone call at least 14 days following their procedure and will be asked about any unexpected or unwanted effects, they may or may not have had following your procedure.
- Their endoscopist will recommend the procedure be repeated as part of standard of care for surveillance following the removal of the polyp. If the patient returns for these, we will collect information about each upper endoscopy at that time.
- If patients undergo an upper endoscopy at another location, we will collect this information from their medical records.
- If a patient comes back for another upper endoscopy to remove a polyp 10 millimeters in size or larger in the next 5 years, we will also collect data about the removal of this polyp, and the patient will once again receive a phone call asking the same questions. If the endoscopist opts for a method other than CS-EMR, we will document the reason why.
Eligibility of study
Inclusion criteria
- Presents for an upper endoscopy for cold snare resection of a ≥ 10 mm duodenal polyp during the procedure with predicted histologic diagnosis of an adenoma.
Exclusion criteria
- Polyp <10mm in largest dimension.
- Polyp with features suggestive of submucosal cancer.
- Polyp with involvement of the empulla.
Department
IN-GAST
IN-GAST