NCT04756453

The Effect of Clip-traction on ESD Resection Time.

The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.

Detailed description

Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD. Location, morphology and size of the lesion will be recorded. Time of the procedure will be measured using a stopwatch

Conditions

• Adenoma Colon

Interventions

Type	Name	Description
DEVICE	clip-traction	A endoscopic clip with a loop of tied dental floss will be attached to the lesion. The loop will then be caught by another endoscopic clip and attached to adjacent bowel wall, thus creating tension in the tissue, making dissection easier.

Timeline

• Start date: 2021-02-15
• Primary completion: 2025-11-15
• Completion: 2025-11-15
• First posted: 2021-02-16
• Last updated: 2024-10-15

Locations

1 site across 1 country: Sweden