The Effect of Clip-traction on ESD Resection Time.

Karolinska Institute

Status: Enrolling

Conditions: Adenoma Colon

Treatments: Device: clip-traction

Study type: Interventional

Funder types: Other

Identifiers

NCT04756453

2020-06741

Details and patient eligibility

About

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.

Full 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

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

280 participants in 2 patient groups

Standard

No Intervention group

Description:

Standard endoscopic submucosal dissection

Interventional

Active Comparator group

Description:

Mandatory use of the clip-traction device

Treatment:

Device: clip-traction