The Impact of Traction Assisted ESD on Procedural Time and Outcome

NCT03180788 | Withdrawn

• 1 other identifier: CLIPTHREAD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the role of traction assisted ESD in comparison to traditional ESD on procedural time and outcome in patients with large, non pedunculated colorectal polyps.

Conditions

Colorectal Polyp

Keywords

ESD; Traction assisted ESD; Polypectomy; Clip and thread ESD

Outcome Measures

Primary Outcomes (1)

• Procedural time

  Time consumption to complete the resection is measured.

  280 min, procedural time

Secondary Outcomes (3)

• En bloc resection

  280 min, procedural time

• R0 resection

  4-8 weeks, when pathological examination is completed

• Complication incidence

  2 weeks, when the timeframe for delayed complications is over.

Study Arms (2)

Traditional ESD

ACTIVE COMPARATOR

The patients in this Group will undergo traditional ESD.

Procedure: Traditional ESD

Traction assisted ESD

EXPERIMENTAL

The patients in this Group will undergo traction assisted ESD

Procedure: Traction assisted ESD

Interventions

Traction assisted ESD PROCEDURE

A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD

Traction assisted ESD

Traditional ESD PROCEDURE

Endoscopic submucosa dissection

Traditional ESD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 2cm, flat or sessile colorectal polyp

You may not qualify if:

• Recurrencies.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospitals

Malmo, Skåne County, Sweden

Location

Related Publications (2)

• Saito Y, Uraoka T, Yamaguchi Y, Hotta K, Sakamoto N, Ikematsu H, Fukuzawa M, Kobayashi N, Nasu J, Michida T, Yoshida S, Ikehara H, Otake Y, Nakajima T, Matsuda T, Saito D. A prospective, multicenter study of 1111 colorectal endoscopic submucosal dissections (with video). Gastrointest Endosc. 2010 Dec;72(6):1217-25. doi: 10.1016/j.gie.2010.08.004. Epub 2010 Oct 27.

  PMID: 21030017 BACKGROUND

• Ritsuno H, Sakamoto N, Osada T, Goto SP, Murakami T, Ueyama H, Mori H, Matsumoto K, Beppu K, Shibuya T, Nagahara A, Ogihara T, Watanabe S. Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. Surg Endosc. 2014 Nov;28(11):3143-9. doi: 10.1007/s00464-014-3572-0. Epub 2014 May 31.

  PMID: 24879138 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomisation to either traction assisted ESD or traditional ESD
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomiced Clinical trial

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 8, 2017
• Study Start: January 8, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 30, 2018
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)