All studies
RecruitingNAINTERVENTIONAL

Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps

This study is investigating improved ways to prevent large bowel polyps from growing back after they've been removed. These polyps can sometimes develop into bowel cancer, so removing them completely is very important. When doctors remove these large polyps with a procedure called EMR, they sometimes come back. We are comparing two methods, called h-APC and STSC, which involve treating the area where the polyp was removed with heat. The aim is to see if one of these methods is better at preventing the polyps from recurring. This could lead to fewer follow-up procedures and reduce the risk of bowel cancer for patients.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrolment target
892
Start
19 Jul 2024
Estimated completion
01 Apr 2028

What is this study about?

This research study is about finding the best way to remove large growths, called polyps, from your bowel and stop them from returning. These large polyps, especially those that are spread out flat (called laterally spreading lesions or LSLs), are important to remove because they can sometimes develop into bowel cancer if left untreated. Doctors currently remove these polyps using a procedure called endoscopic mucosal resection (EMR), which involves using a special tool that goes through your mouth and down into your bowel.

Even after EMR, these polyps can sometimes grow back. This study is testing two different methods that are used *after* the main polyp has been removed, to treat the area where it was, to hopefully prevent it from recurring. One method is called hybrid argon plasma coagulation (h-APC), and the other is called Snare tip soft coagulation (STSC). Both use heat to treat the area. We want to find out if one of these methods is better than the other at making sure the polyps don't come back, which could mean less worry and fewer procedures for patients in the future.

By comparing these two techniques, we hope to improve the standard treatment for large bowel polyps. This could help prevent bowel cancer, avoid the need for more complex surgery, and ultimately improve the health and well-being of people who have these types of polyps.

Key takeaways

  • New study comparing two treatments to stop large bowel polyps from returning.
  • Aims to reduce recurrence of polyps that can sometimes become cancerous.
  • Uses h-APC or STSC heat treatment after standard polyp removal (EMR).
  • Participation involves being randomly assigned to one of the two treatments.
  • Could lead to better long-term outcomes and fewer future procedures.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who are scheduled to have a large polyp removed from their bowel using a keyhole procedure called Endoscopic Mucosal Resection (EMR). You would need to be well enough for the procedure and agree to take part by signing a consent form.

There are certain reasons why you might not be able to join the study. For example, if you have inflammatory bowel disease (like Crohn's or Colitis), if your procedure is an emergency, or if you have certain blood clotting problems. You also wouldn't be able to join if your polyp is on a stalk (pedunculated) or if there are already clear signs that the polyp is an advanced cancer.

Pregnant women also cannot take part. If you're unsure whether you meet these descriptions, your doctor can help clarify if this study might be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you scheduled to have a large bowel polyp removed by EMR?
  3. Do you feel generally well and healthy?
  4. Do you *not* have inflammatory bowel disease (e.g., Crohn's, Colitis)?
  5. Are you *not* pregnant?
  6. Do you *not* have a bleeding disorder or blood clotting issues?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to read and sign a consent form. Before your procedure, you will follow a standard bowel preparation routine, just as you would for any colonoscopy. During the procedure, after your large bowel polyp has been removed by the usual method (EMR), you will be randomly assigned to receive one of two additional treatments to the area where the polyp was. One group will receive h-APC treatment to the edges and base of the treated area, and the other group will receive STSC treatment only to the edges. Which group you're in will be decided by chance, like flipping a coin. These additional treatments happen during your scheduled endoscopy. The total added time to your procedure for the study intervention will be minimal. After your procedure, your doctor will discuss any follow-up appointments, which will be similar to standard care.

Potential risks and benefits

By taking part in this study, you might benefit from receiving a new technique that could be more effective at preventing your polyp from regrowing. However, there's also a chance you'll receive the current standard treatment. As with any medical procedure, there are potential risks involved with both types of treatment, such as bleeding or a small tear in the bowel, but these are rare and your medical team is highly experienced in managing them. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Centre Hospitalier de l'Université de Montréal
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What is a polyp?

A polyp is a small growth on the lining of your bowel. Some polyps can turn into cancer over time, so removing them is important.

What is EMR?

EMR stands for Endoscopic Mucosal Resection. It's a keyhole procedure where doctors use a special tool inserted through your mouth to remove polyps from your bowel.

What are h-APC and STSC?

These are two different methods that use heat to treat the area where a polyp was removed. The aim is to destroy any remaining tiny cells and prevent the polyp from growing back.

Will I know which treatment I'm getting?

No, you won't know which of the two treatments you're receiving. This is done by chance to make sure the study results are fair and unbiased.

Does this study involve extra appointments?

The main part of the study happens during your planned endoscopy. Any follow-up appointments after that would be similar to what you'd typically have after a polyp removal.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Reducing Neoplasia Recurrence After Endoscopic Resection of …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.