Accepted Manuscript Endoscopic suturing for ulcer exclusion in patients with massively bleeding large gastric ulcer Philip Wai Yan CHIU, MD, FRCSEd, Francis Ka Leung CHAN, MD, PhD, James Yun Wong LAU, MD, FRCSEd PII: DOI: Reference:

S0016-5085(15)00645-9 10.1053/j.gastro.2015.04.054 YGAST 59771

To appear in: Gastroenterology Accepted Date: 13 April 2015 Please cite this article as: CHIU PWY, CHAN FKL, LAU JYW, Endoscopic suturing for ulcer exclusion in patients with massively bleeding large gastric ulcer, Gastroenterology (2015), doi: 10.1053/ j.gastro.2015.04.054. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. All studies published in Gastroenterology are embargoed until 3PM ET of the day they are published as corrected proofs on-line. Studies cannot be publicized as accepted manuscripts or uncorrected proofs.

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Gastroenterology in motion

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Endoscopic suturing for ulcer exclusion in patients with massively bleeding large gastric ulcer MD, FRCSEd

Francis Ka Leung, CHAN

MD, PhD

James Yun Wong, LAU

MD, FRCSEd

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Philip Wai Yan, CHIU

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[Authors and Affiliations]

Institute of Digestive Disease, The Chinese University of Hong Kong [Correspondence]

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Philip WY Chiu

Director, CUHK Jockey Club Minimally Invasive Surgical Skills Center;

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Director, CUHK Chow Yuk Ho Technology Center for Innovative Medicine; Professor, Department of Surgery, Institute of Digestive Disease, Prince of Wales Hospital, The

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Chinese University of Hong Kong

Email: [email protected] Phone: (852)26322627 Fax: (852)26377974 [Disclosure]

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All the authors has no conflict of interest to declare for this study. This study did not receive support from any research grant.

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[Authors’ responsibility] Philip Chiu is responsible for study design, performance of the procedures, analysis of data and drafting of the manuscript. Francis Chan is responsible for study design and critical comment of

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the results and manuscript. James Lau is responsible for study design, performance of the

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procedures, analysis of the data and critical comment of the manuscript.

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Introduction (1 paragraph without heading) Bleeding peptic ulcer is one of the important causes for hospitalization worldwide. Though

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endoscopic hemostasis is the current standard of treatment for bleeding peptic ulcers, ulcer rebleeding remained an important cause of mortality [1]. One of the important strategies to improve outcomes for bleeding peptic ulcers is to prevent rebleeding. Indeed, endoscopic

features for ulcers with high risk of rebleeding included ulcers larger than 2cm, actively bleeding

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and those located at posterior duodenal bulb or high lesser curvature [3]. With the use of high

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dose intravenous proton pump inhibitors (PPI), those who developed rebleeding after PPI infusion are patients with significant perioperative risks, high proportion of comorbidities as well as older age which rendered them high risk surgical candidates [4]. Prototype endoscopic suturing device had been investigated for the safety and efficacy in achieving hemostasis among massively bleeding gastric ulcers [5]. This is the first report on the clinical application of surgical

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ulcer exclusion using endoscopic suturing for large bleeding gastric ulcer.

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Description of Technology (1 paragraph) The Apollo Overstitch is an endoscopic suturing system which consisted of a cap based suturing

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system with a curved suture arm extending from one of the dual channels and the anchor exchange system extending from the same channel (Figure 1). The handle to control the suture plication system was mounted onto the shaft of double channel endoscope (Olympus 2T100 scope, Olympus Co Ltd, Hong Kong). The Overstitch system attached to double channel

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endoscope was introduced into the stomach through an overtube. The bleeding ulcer was first

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located with ordinary single channel endoscope. Endoscopic suturing began with the needle first driven through distal edge of the bleeding ulcer. After closing of the curved needle driver, the detachable needle would be grapsed by the anchor exchange and detached from the needle driver. After opening the needle driver, the endoscope with Overstitch would be moved away from the distal ulcer edge. The needle would be placed back to the needle driver by the anchor exchange.

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The needle should then be driven over the proximal edge of the ulcer and the procedure was repeated until the two edges of the ulcer could be pulled together. The needle anchor would be dropped, while the anchor exchange was replaced by the cinching device which passed along the

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2 ‘O’ polypropylene suture. After passage of the cinch to ulcer edge, the polypropylene suture would be tightened against the end of the cinch. The cinch was then closed to cut the stitch and

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released the plug to tighten the suture, and the ulcer would be excluded from intragastric high acidity environment to stop current bleeding and prevent rebleeding.

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Video Description (2 paragraph) Three patients received endoscopic ulcer exclusion for massively bleeding gastric ulcer. This

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video showed the endoscopic suturing for ulcer exclusion in an actively bleeding gastric ulcer. The patient was 78 years old gentleman who presented with passage of tarry stool for 3 days, with upper endoscopy showing a 2cm large gastric ulcer at angular incisura with visible vessel. There was active bleeding from visible vessel. The Overstitch device was introduced through an

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overtube. The first suture plication was performed over the superior edge of the ulcer. After

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exchange of the anchor, the second suture plication was performed over the inferior ulcer edge. This process was continued until a figure of eight suture was formed over the ulcer. The anchor was then dropped and the suture was tightened with the cinching device. The ulcer was excluded with adequate hemostasis (Figure 2). The patient had no clinical evidence of rebleeding, and

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repeated endoscopy in 72 hours confirmed secure closure of the ulcer.

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Take home message (implications/significance of video demonstration (one to 8 sentences) Surgical exclusion of bleeding ulcer is a conventional treatment for prevention of further

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bleeding through suture closure of the ulcer and excluding it from intragastric acidity. This is the first technological report on clinical application of endoscopic surgical suturing for ulcer exclusion. The success of endoscopic ulcer exclusion will lead to improvement in primary endoscopic hemostasis, and theoretically excluding the ulcer from acid to prevent further bleeding. The ulcer exclusion shall be a better method to prevent rebleeding compared to adjunctive high dose proton pump inhibitor infusion or prophylactic angiographic embolization.

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References (no more than 8, using the abbreviated Brief Report format) 1. Chiu PW, Ng EK, Cheung FK, Chan FK, Leung WK, Wu JC, Wong VW, Yung MY, Tsoi K,

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Lau JY, Sung JJ, Chung SS. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol. 2009 Mar;7(3):311-6.

2. Johnston JH, Jensen DM, Auth D. Experimental comparison of endoscopic yttrium-

aluminum-garnet laser, electrosurgery, and heater probe for canine gut arterial coagulation.

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Importance of compression and avoidance of erosion. Gastroenterology. 1987 May; 92(5 Pt

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1):1101-8.

3. Elmunzer BJ, Young SD, Inadomi JM, Schoenfeld P, Laine L. Systematic review of the predictors of recurrent hemorrhage after endoscopic hemostatic therapy for bleeding peptic ulcers. American Journal of Gastroenterology 2008; 103:2625-2632 4. Chiu PW, Ng EK, Wong SK, Teoh AY, Cheung FK, Yung MY, Sung JJ, Lau JY. Surgical

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2009;26(3):243-8.

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salvage of bleeding peptic ulcers after failed therapeutic endoscopy. Dig Surg.

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Endoscopic Suturing for Ulcer Exclusion in Patients With Massively Bleeding Large Gastric Ulcer.

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