Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)

Background and aims: After Peroral Endoscopic Myotomy (POEM), the mucosal incision is closed with endoscopically applied clips. After each clip placement, a subsequent clipping device has to be introduced through the working channel. With the Clipmaster3, three consecutive clips can be placed withou...

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Main Authors: Tessa Verlaan, Fraukje A. M. Ponds, Barbara A. J. Bastiaansen, Albert J. Bredenoord, Paul Fockens
Format: Article
Language:English
Published: Georg Thieme Verlag KG 2016-09-01
Series:Endoscopy International Open
Online Access:http://www.thieme-connect.de/DOI/DOI?10.1055/s-0042-113126
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author Tessa Verlaan
Fraukje A. M. Ponds
Barbara A. J. Bastiaansen
Albert J. Bredenoord
Paul Fockens
author_facet Tessa Verlaan
Fraukje A. M. Ponds
Barbara A. J. Bastiaansen
Albert J. Bredenoord
Paul Fockens
author_sort Tessa Verlaan
collection DOAJ
description Background and aims: After Peroral Endoscopic Myotomy (POEM), the mucosal incision is closed with endoscopically applied clips. After each clip placement, a subsequent clipping device has to be introduced through the working channel. With the Clipmaster3, three consecutive clips can be placed without reloading which could reduce closure time. We performed a prospective study evaluating efficacy, safety, and ease of use. Closure using Clipmaster3 was compared to closure with standard clips. Methods: Patients undergoing closure with the Clipmaster3 were compared to patients who underwent POEM with standard clip closure. Results: In total, 12 consecutive POEM closures with Clipmaster3 were compared to 24 standard POEM procedures. The Clipmaster3 and the standard group did not differ in sex distribution, age (42 years [29 – 49] vs 41 years [34 – 54] P = 0.379), achalasia subtype, disease duration, length of the mucosal incision (25.0 mm [20 – 30] vs 20.0 mm [20 – 30], P = 1.0), and closure time (622 seconds [438 – 909] vs 599 seconds [488 – 664] P = 0.72). Endoscopically successful closure could be performed in all patients. The proportion of all clips used that were either displaced or discarded was larger for Clipmaster3 (8.8 %) compared to standard closure (2.0 %, P  = 0.00782). Ease of handling VAS (visual analogue scale) score for Clipmaster3 did not differ between endoscopist and endoscopy nurse (7 out of 10). Conclusions: Clipmaster3 is feasible and safe for closure of mucosal incisions after POEM. Clipmaster3 was not associated with reduced closure time. Compared to standard closure, more Clipmaster3 clips were displaced or discarded to achieve successful closure. A training effect cannot be excluded as a cause of these results. Study registration: NCT01405417
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spelling doaj.art-29d3fab7961145bfa796168fc91407c62022-12-22T00:09:18ZengGeorg Thieme Verlag KGEndoscopy International Open2364-37222196-97362016-09-010410E1052E105610.1055/s-0042-113126Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)Tessa Verlaan0Fraukje A. M. Ponds1Barbara A. J. Bastiaansen2Albert J. Bredenoord3Paul Fockens4Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The NetherlandsBackground and aims: After Peroral Endoscopic Myotomy (POEM), the mucosal incision is closed with endoscopically applied clips. After each clip placement, a subsequent clipping device has to be introduced through the working channel. With the Clipmaster3, three consecutive clips can be placed without reloading which could reduce closure time. We performed a prospective study evaluating efficacy, safety, and ease of use. Closure using Clipmaster3 was compared to closure with standard clips. Methods: Patients undergoing closure with the Clipmaster3 were compared to patients who underwent POEM with standard clip closure. Results: In total, 12 consecutive POEM closures with Clipmaster3 were compared to 24 standard POEM procedures. The Clipmaster3 and the standard group did not differ in sex distribution, age (42 years [29 – 49] vs 41 years [34 – 54] P = 0.379), achalasia subtype, disease duration, length of the mucosal incision (25.0 mm [20 – 30] vs 20.0 mm [20 – 30], P = 1.0), and closure time (622 seconds [438 – 909] vs 599 seconds [488 – 664] P = 0.72). Endoscopically successful closure could be performed in all patients. The proportion of all clips used that were either displaced or discarded was larger for Clipmaster3 (8.8 %) compared to standard closure (2.0 %, P  = 0.00782). Ease of handling VAS (visual analogue scale) score for Clipmaster3 did not differ between endoscopist and endoscopy nurse (7 out of 10). Conclusions: Clipmaster3 is feasible and safe for closure of mucosal incisions after POEM. Clipmaster3 was not associated with reduced closure time. Compared to standard closure, more Clipmaster3 clips were displaced or discarded to achieve successful closure. A training effect cannot be excluded as a cause of these results. Study registration: NCT01405417http://www.thieme-connect.de/DOI/DOI?10.1055/s-0042-113126
spellingShingle Tessa Verlaan
Fraukje A. M. Ponds
Barbara A. J. Bastiaansen
Albert J. Bredenoord
Paul Fockens
Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)
Endoscopy International Open
title Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)
title_full Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)
title_fullStr Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)
title_full_unstemmed Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)
title_short Single clips versus multi-firing clip device for closure of mucosal incisions after peroral endoscopic myotomy (POEM)
title_sort single clips versus multi firing clip device for closure of mucosal incisions after peroral endoscopic myotomy poem
url http://www.thieme-connect.de/DOI/DOI?10.1055/s-0042-113126
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