The Impact of Traction Assisted ESD on Procedural Time and Outcome

Region Skane

Status: Withdrawn

Conditions: Colorectal Polyp

Treatments: Procedure: Traction assisted ESD; Procedure: Traditional ESD

Study type: Interventional

Funder types: Other

Identifiers

NCT03180788

CLIPTHREAD

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 2cm, flat or sessile colorectal polyp

Exclusion criteria

• Recurrencies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Traditional ESD

Active Comparator group

Description:

The patients in this Group will undergo traditional ESD.

Treatment:

Procedure: Traditional ESD

Traction assisted ESD

Experimental group

Description:

The patients in this Group will undergo traction assisted ESD

Treatment:

Procedure: Traction assisted ESD