The Effect of Clip-traction on ESD Resection Time.

Adenoma Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04756453
• Other study ID #: 2020-06741
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: November 15, 2024

Study information

• Verified date: March 2023
• Source: Karolinska Institutet
• Contact: Richard Marsk, MD,PhD
• Phone: +46812358108
• Email: richard.marsk[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon

Intervention

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.

Locations

Country	Name	City	State
Sweden	Endoskopicentrum Danderyds Sjukhus	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resection speed (mm2/min)	Measured as area of the removed lesion divided by procedure time.	Within completion of procedure