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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional ESD | Active Comparator | The patients in this Group will undergo traditional ESD. |
|
| Traction assisted ESD | Experimental | The patients in this Group will undergo traction assisted ESD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traction assisted ESD | Procedure | A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural time | Time consumption to complete the resection is measured. | 280 min, procedural time |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skane University Hospitals | Malmö | Skåne County | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21030017 | Background | 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. | |
| 24879138 |
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Prospective randomiced Clinical trial
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Randomisation to either traction assisted ESD or traditional ESD
| Traditional ESD | Procedure | Endoscopic submucosa dissection |
|
| 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. |
| 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. |