The Impact of Traction Assisted ESD on Procedural Time and Outcome (ESD)

The Impact of Traction Assisted ESD on Procedural Time, En Bloc Resection, Curative Resection and Complication Incidence

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.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Polyp
• Intervention / Treatment: Procedure: Traditional ESD; Procedure: Traction assisted ESD

Detailed Description

Endoscopic polypectomy, has been proven to reduce Colorectal cancer incidence and mortality. Smaller lesions and pedunculated lesions can be removed by conventional polypectomy, Endoscopic mucosa resection (EMR). However, large sessile and flat lesions are difficult to remove En bloc with EMR, resulting in a high level of tumor recurrence. Endoscopic submucosal dissection (ESD) was developed during the 1990s in Japan to achieve En bloc resection of large neoplasms in the stomach but has in recent years also been extended into management of large (>2 cm) and technically challenging colorectal polyps. Large series on the efficacy of ESD in removing benign lesions show high En bloc resection rates resulting in low numbers of recurrences. Traction assisted ESD was developed in Japan to further improve the technique and reduce procedural time, the literature on the efficacy of traction assisted ESD is however scarce and limited to Japanese studies.

The aim in this study is to investigate the impact of this novel technique in comparison to traditional ESD on procedural time, En bloc resection rate, R0 resection rate and complication incidence.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Malmö, Skåne, Sweden
      • Skane University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 2cm, flat or sessile colorectal polyp

Exclusion Criteria:

• Recurrencies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional ESD; The patients in this Group will undergo traditional ESD.	Procedure: Traditional ESD; Endoscopic submucosa dissection
EXPERIMENTAL: Traction assisted ESD; The patients in this Group will undergo traction assisted ESD	Procedure: Traction assisted ESD; A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time	Time consumption to complete the resection is measured.	280 min, procedural time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
En bloc resection	En bloc resection rates will be recorded	280 min, procedural time
R0 resection	R0 resection rate, stated in the pathology report will be recorded	4-8 weeks, when pathological examination is completed
Complication incidence	All complications both immediate and delayed will be recorded	2 weeks, when the timeframe for delayed complications is over.

Collaborators and Investigators

• Sponsor: Region Skane

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 8, 2018
• Primary Completion (ANTICIPATED): December 20, 2018
• Study Completion (ANTICIPATED): December 30, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (ACTUAL): June 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: ESD; Polypectomy; Traction assisted ESD; Clip and thread ESD
• Other Study ID Numbers: CLIPTHREAD

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