The Effect of Clip-traction on ESD Resection Time.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adenoma Colon
• Intervention / Treatment: Device: clip-traction

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

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard Marsk, MD,PhD; Phone Number: +46812358108; Email: richard.marsk@ki.se
• Study Contact Backup: Name: Björn Törnqvist, MD,PhD; Phone Number: +46812358477; Email: bjorn.tornqvist@sll.se

Study Locations

• Sweden
  • Stockholm, Sweden, 18288
    • Recruiting
    • Endoskopicentrum Danderyds Sjukhus
    • Contact: Richard Marsk, PhD; Phone Number: 0707608310; Email: richard.marsk@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; Standard endoscopic submucosal dissection
Active Comparator: Interventional; Mandatory use of the clip-traction device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection speed (mm2/min)	Measured as area of the removed lesion divided by procedure time.	Within completion of procedure

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Richard Marsk, MD,PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): November 15, 2025

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 2020-06741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No