Using a traction device to improve endoscopic resection time for colon adenomas.
The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial
This study tests if using a special traction device can help doctors remove colon adenomas faster during a procedure for patients with early colorectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT04756453 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a traction device on the resection time during endoscopic submucosal dissection (ESD) for patients with adenomas or early colorectal cancer. Participants will be randomly assigned to either the traction device group, which utilizes an endoscopic clip and dental floss, or the standard ESD procedure. The study will measure the time taken for the procedure and record details about the lesions being treated. This approach aims to enhance the efficiency of ESD, potentially leading to better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with adenomas or early colorectal cancer suitable for endoscopic submucosal dissection.
Not a fit: Patients with dementia or those unable to understand the study information may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more efficient removal of colorectal lesions, improving patient care.
How similar studies have performed: While the use of traction devices in ESD is a novel approach, similar studies have shown promise in improving procedural efficiency.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * a lesion in the colon or rectum suitable for removal by the ESD technique Exclusion Criteria: * dementia * inability to understand the written study information
Where this trial is running
Stockholm
- Endoskopicentrum Danderyds Sjukhus — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Richard Marsk, MD,PhD — Karolinska Institutet
- Study coordinator: Richard Marsk, MD,PhD
- Email: richard.marsk@ki.se
- Phone: +46812358108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.