The Impact of Traction Assisted ESD on Procedural Time and Outcome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Polyp

Intervention / Treatment
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* Procedure: Traction assisted ESD
* Procedure: Traditional ESD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 2cm, flat or sessile colorectal polyp Exclusion Criteria: Recurrencies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomiced Clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional ESD<br>The patients in this Group will undergo traditional ESD. | Procedure: Traditional ESD<br>* Endoscopic submucosa dissection<br>|
| Experimental: Traction assisted ESD<br>The patients in this Group will undergo traction assisted ESD | Procedure: Traction assisted ESD<br>* A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESD, Traction assisted ESD, Polypectomy, Clip and thread ESD