The Impact of Traction Assisted ESD on Procedural Time and Outcome

Colorectal Polyp Clinical Trial

— ESD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03180788
• Other study ID #: CLIPTHREAD
• Status: Withdrawn
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2021
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• > 2cm, flat or sessile colorectal polyp

Exclusion Criteria:

• Recurrencies.

Related Conditions & MeSH terms

• Colorectal Polyp

Intervention

Procedure:
• Traction assisted ESD
A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD
• Traditional ESD
Endoscopic submucosa dissection

Locations

Country	Name	City	State
Sweden	Skane University Hospitals	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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 colorec — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural time	Time consumption to complete the resection is measured.	280 min, procedural time
Secondary	En bloc resection	En bloc resection rates will be recorded	280 min, procedural time
Secondary	R0 resection	R0 resection rate, stated in the pathology report will be recorded	4-8 weeks, when pathological examination is completed
Secondary	Complication incidence	All complications both immediate and delayed will be recorded	2 weeks, when the timeframe for delayed complications is over.