Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Traction assisted ESD | A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD |
| PROCEDURE | Traditional ESD | Endoscopic 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.