The Impact of Traction Assisted ESD on Procedural Time and Outcome

NCT ID: NCT03180788

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2018-12-30

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.

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.

Conditions

Colorectal Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional ESD

The patients in this Group will undergo traditional ESD.

Group Type: ACTIVE_COMPARATOR

Traditional ESD

Intervention Type: PROCEDURE

Endoscopic submucosa dissection

Traction assisted ESD

The patients in this Group will undergo traction assisted ESD

Group Type: EXPERIMENTAL

Traction assisted ESD

Intervention Type: PROCEDURE

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

Interventions

Traction assisted ESD

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

Intervention Type: PROCEDURE

Traditional ESD

Endoscopic submucosa dissection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• > 2cm, flat or sessile colorectal polyp

Exclusion Criteria

• Recurrencies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Skane University Hospitals

Malmo, Skåne County, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 21030017 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24879138 (View on PubMed)

Other Identifiers

CLIPTHREAD

Identifier Type: -

Identifier Source: org_study_id