Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03180788

The Impact of Traction Assisted ESD on Procedural Time and Outcome

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Region Skane · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURETraction assisted ESDA clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD
PROCEDURETraditional ESDEndoscopic submucosa dissection

Timeline

Start date
2018-01-08
Primary completion
2018-12-20
Completion
2018-12-30
First posted
2017-06-08
Last updated
2021-02-15

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03180788. Inclusion in this directory is not an endorsement.