Case report/series

Use of the Over-The-Scope Clip for treatment of refractory upper gastrointestinal bleeding: a case series

Authors

Shannon M. Chan, Philip W. Y. Chiu, Anthony Y. B. Teoh, James Y. W. Lau

Institution

Department of Surgery, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong SAR, China

submitted 5. November 2013 after revision 22. December 2013

The Over-The-Scope Clip (OTSC; Ovesco, Tübingen, Germany) is a novel endoscopic clipping device designed for tissue approximation. The device has been used in the closure of fistulas and perforations. We hereby report on a series of patients in whom OTSCs were used for endoscopic control of refractory or major upper gastrointestinal bleeding from lesions in the gastroduodenal tract between 1 July and 31 December 2012. Nine patients were included (median age 72.5 years, range 39 – 91) with bleeding gastric ulcers (n = 2), bleeding duodenal ulcers (n = 5), bleeding gastrointestinal stromal tumor in the stomach

(n = 1), and bleeding from ulcerative carcinoma of the pancreas (n = 1). The median size of the ulcers was 2.5 cm (range 1 – 4). Six of the nine patients had undergone previous endoscopic hemostasis. Technical success was achieved in all patients and the clinical effectiveness was 77.8 %. The OTSC is a safe and effective method of endoscopic hemostasis for major bleeding from miscellaneous upper gastrointestinal causes and should be considered in patients with refractory bleeding after failure of conventional methods of endoscopic hemostasis.

Introduction

perienced endoscopists. Patient demographic data, indication for esophagogastroduodenoscopy (EGD), previous methods of endoscopic hemostasis, cause, site and location of the bleeding, and the technical and clinical success of endoscopic hemostasis were reviewed. Technical success of endoscopic hemostasis was defined as hemostasis achieved with the OTSC at index endoscopy. Clinical effectiveness was defined as achieving technical success with no rebleeding. Clinical rebleeding was defined as development of fresh hematemesis, shock (defined as a systolic blood pressure of ≤ 90 mmHg or a pulse rate of ≥ 110 beats per minute) with melena after stabilization, or a drop in hemoglobin of more than 2 g/dL within 24 hours after transfusion to a level of 10 g/dL. Emergency endoscopy was performed when rebleeding was suspected. Additional surgical or radiological interventions in the event of uncontrolled bleeding were also recorded. The duration of the OTSC in situ was recorded, defined as the OTSC being seen on followup EGD or on the latest abdominal radiograph.

Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1364932 Published online: 6.2.2014 Endoscopy 2014; 46: 428–431 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author James Y. W. Lau, MD Department of Surgery Prince of Wales Hospital The Chinese University of Hong Kong 30–32 Ngan Shing Street Shatin Hong Kong Fax: +852-26377974 [email protected]

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Hemostatic clips achieve hemostasis through mechanical tamponade over the bleeding vessel. Tangential application of hemostatic clips can be difficult in lesions located in the bulbar duodenum and the lesser curvature of the stomach. Furthermore, hemostatic clips often dislodge leading to recurrent bleeding. Application of clips can also sometimes be difficult in chronic ulcers with fibrotic bases. A novel endoscopic clipping device, the Over-The-Scope Clip (OTSC; Oversco Endoscopy AG, Tübingen, Germany) has become available and the device provides a robust and strong tissue apposition mechanism. This study evaluated the clinical safety and efficacy of the OTSC system for the management of difficult cases of acute nonvariceal upper gastrointestinal bleeding.

Patients and methods !

This prospective series included all patients who underwent endoscopic hemostasis using the OTSC for acute nonvariceal upper gastrointestinal bleeding between 1 July and 31 December 2012 at the endoscopy center of the Prince of Wales Hospital. All procedures were performed by two ex-

Chan Shannon M et al. OTSC for refractory UGIB … Endoscopy 2014; 46: 428–431

The OTSC system The Over-The-Scope Clip is made from nitinol alloy and attached to a transparent applicator in a pre-bent state. In the current series it was deliv-

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ered by means of an applicator cap mounted to the tip of a gastroscope. In chronic ulcers, an anchor device was used to pull the ulcer base toward the aspiration cap. The clip was then released by tightening the thread with the hand wheel with a mechanism similar to rubber band variceal ligation. After being released from the applicator, the shape-memory effect and elasticity of " Fig. 1 a, ● " Fig. 1 b). In the alloy resulted in closure of the clip (● our study, the OTSC t clips with pointed teeth were used. The length and diameter of the OTSCs used were selected at the discretion of the endoscopist.

Results A total of nine patients were recruited to the study and 10 OTSCs were applied. The median age was 72.5 years (range 39 – 89), and " Table 1). Upper gastrothere were four men and five women (● intestinal bleeding was caused by gastric ulcers in two patients, duodenal ulcers in five patients, gastrointestinal stromal tumor of the stomach in one patient, and adenocarcinoma of the pancreas in one patient. Six of the nine patients had undergone previous endoscopic hemostasis. The median size of the ulcers was 2.5 cm (range 1 – 4). All of these ulcers or tumors demonstrated the presence of a visible vessel upon endoscopy. The technical success rate of OTSC was 100 % and endoscopic hemostasis was achieved in all patients. There was no local complication. Two patients experienced rebleeding, which required further intervention and thus the clinical effectiveness was 77.8 %. Seven patients underwent follow-up EGD 8 weeks after hemostasis. All of the ulcers were confirmed to have healed completely. The median duration of the OTSC in situ was 28 days (range 0 – 42). Two patients who had complex duodenal ulcers developed rebleeding after OTSC application. One patient was treated with radiotherapy for residual disease after resection of common bile duct cholangiocarcinoma. On initial EGD, a 3-cm actively bleeding ulcer was noted in the first part of the duodenum (D1); endoscopic hemostasis failed and transarterial embolization of the gastroduodenal artery was performed. The patient then developed rebleeding and underwent EGD with OTSC application to stop the bleeding. Rebleeding occurred again 3 days later and he underwent emergency surgical plication of the ulcer. However, he suffered another episode of rebleeding 12 days after surgery and required a second EGD with OTSC application for hemostasis (Video 1). Three days later, he developed another rebleeding with shock; however, he was too frail to undergo repeat surgery. Another attempt at endoscopic hemostasis failed and he died. Postmortem examination showed that the cholangiocarcinoma had recurred locally in the duodenum causing the persistent ulcer.

Video 1

Fig. 1 a Patient #2 (male aged 69 years) presented with hematemesis and shock and had undergone previous endoscopic hemostasis with adrenaline injection and heater probe, both of which had failed. a Angular incisura ulcer with visible vessel.

Fig. 1 b Over-The-Scope Clip applied to the angular incisura ulcer for hemostasis.

In another patient, with a 3-cm circumferential Forrest 1b D1 ulcer who presented with shock, rebleeding occurred despite two episodes of conventional endoscopic hemostasis. Urgent angiogram showed extravasation from the inferior pancreatoduodenal artery and the artery was embolized. Rebleeding occurred shortly afterwards and endoscopic hemostasis was achieved after application of OTSC. This patient developed clinical rebleeding a few hours after EGD and urgent angiogram with further embolization of the gastroduodenal artery was performed.

Discussion The application of an Over-The-Scope Online content including Clip to a D1 ulcer with active spurt- video sequences viewable at: www.thieme-connect.de ing, in which previous endoscopic and surgical hemostasis had failed.

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Therapeutic endoscopy is the current standard for hemostasis in patients with bleeding peptic ulcers [1]. Numerous methods of endoscopic hemostasis have been developed, and endoscopic

Chan Shannon M et al. OTSC for refractory UGIB … Endoscopy 2014; 46: 428–431

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

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Chan Shannon M et al. OTSC for refractory UGIB … Endoscopy 2014; 46: 428–431

M

M

F

F

M

F

F

M

F

1

2

3

4

5&6

7

8

9

10

89

75

39

83

69

70

70

69

79

years

Age,

D1 /D2

D1 /D2

High lesser curve

D1 /D2

D1

D1 /D2

D1

Angular incisura

Angular incisura

Site

Ulcer

Ulcer

GIST

Ulcer

Ulcer

Pancreatic tumor

Ulcer

Ulcer

Ulcer

Diagnosis

4

1

2

2.0

3

2

3

3

1.5

cm

lesion,

Size of

No

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

fusion

Prior trans-

Yes

Yes

Yes

Yes

No

Shock

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

oozing

Spurting/

2

1

0

1

6

2

0

2

1

Adrenaline Heater probe

Yes

Yes

Yes

– Adrenaline Heater probe Endoclips

Yes

Yes

Adrenaline Endoclips

Adrenaline Endoclips Surgery

Yes

Yes

– Adrenaline Endoclips

Yes

Yes

1 11/6 T

1 11/6 T

1 11/6 T

1 12/6 T

1 12/6 T

1 12/6 T

1 11/6 T

2 11/6 T

1 11/6 T

1 11/6 T

No

No

No

No

No

No

No

No

No

Yes

anchor

used

Yes

tissue

of OTSC

success

Use of

No./type

Technical

Adrenaline Heater probe Endoclips

Adrenaline Heater Probe



methods

0

hemostasis

mostasis

endoscopic

Previous

scopic he-

vious endo-

No. of pre-

Yes

Yes

Yes

Yes

No

No

Yes

No

Yes

Yes

success

Secondary

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

D1, First part of the duodenum; D1 /D2, junction between the first and second parts of the duodenum; GIST, gastrointestinal stromal tumor; OTSC, Over-The-Scope Clip; EGD, esophagogastroduodenoscopy.

Sex

Patient demographic information and results.

No.

Table 1

EGD + hemostasis

Open plication

Angiogram + embolization

procedure

Salvage

No

No

No

No

Yes

No

No

No

No

Mortality

430 Case report/series

Case report/series

part of the duodenum and at the high lesser curvature; location made application of conventional clips difficult as the endoscope would be aligned to the ulcer at an angle. Moreover, repeated application of heater probe in the duodenum is associated with a high risk of perforation [10]. The application of OTSCs in these situations allows for larger amounts of tissue to be captured for compression while avoiding the risk of thermal injury in these locations. The OTSC was also found to be quite durable and remained in situ after a median of 28 days. This gives evidence that the OTSC confers additional security to hemostasis. In conclusion, with this new modification, the use of the OTSC should be considered in refractory bleeding after conventional endoscopic hemostasis, before surgery or angiographic embolization. Competing interests: None

References 1 Cook DJ, Guyatt GH, Salena BJ et al. Endoscopic therapy for acute nonvariceal upper gastrointestinal haemorrhage: a meta-analysis. Gastroenterology 1992; 102: 139 – 148 2 Sung JJ, Tsoi KK, Lai LH et al. Endoscopic clipping versus injection and thermo-coagulation in the treatment of non-variceal upper gastrointestinal bleeding: a meta-analysis. Gut 2007; 56: 1364 – 1373 3 Chiu PW, Ng EK, Cheung FK et al. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol 2009; 7: 311 – 316 4 Hepworth CC, Kadirkamanathan SS, Gong F et al. A randomized controlled comparison of injection, thermal, and mechanical endoscopic methods of haemostasis on mesenteric vessels. Gut 1998; 42: 462 – 469 5 Kirschniak A, Kratt T, Stuker D et al. A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences. Gastrointest Endosc 2007; 66: 162 – 166 6 Manta R, Galloro g, Mangiavillano B et al. Over-the-scope-clip (OTSC) represents an effective endoscopic treatment of acute GI bleeding after failure of conventional techniques. Surg Endosc 2013; 27: 3162 – 3164 7 Johnston JH, Jensen DM, Auth D. Experimental comparison of endoscopic yttrium-aluminum-garnet laser, electrosurgery, and heater probe for canine gut arterial coagulation. Importance of compression and avoidance of erosion. Gastroenterology 1987; 92 : 051101 – 1108 8 Chiu PW, Jeong HK, Choi CL et al. Predictors of peptic ulcer rebleeding after scheduled second endoscopy: clinical or endoscopic factors? Endoscopy 2006; 38: 726 – 729 9 Elmunzer BJ, Young SD, Inadomi JM et al. Systemic review of the predictors of recurrent haemorrhage after endoscopic haemostatic therapy for bleeding peptic ulcers. Am J Gastroenterol 2008; 103: 2625 – 2632 10 Chung SS, Lau JY, Sung JJ et al. Randomised comparison between adrenaline injection alone and adrenaline injection plus heat probe treatment for actively bleeding ulcers. BMJ 1997; 314: 1307 – 1311

Chan Shannon M et al. OTSC for refractory UGIB … Endoscopy 2014; 46: 428–431

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

clipping has been increasingly adopted as a mechanical method of hemostasis of the bleeding vessel at the ulcer base. A meta-analysis comparing endoscopic clipping with conventional injection and thermocoagulation included 1156 patients from 15 randomized trials [2]. Endoclips were shown to achieve a higher rate of permanent hemostasis than injection alone, and clips were as effective as heater probe for ulcer hemostasis. The overall rebleeding rate after endoclipping, however, ranged from 7.1 % to 9.5 %. Rebleeding is a major predictor of adverse outcome. An improved rate of success in the control of bleeding would impact upon patient outcomes [3]. Conventional hemostatic clips achieve hemostasis over the bleeding vessel at the ulcer base through application of mechanical force between the two jaws. Secure application of the hemoclips to the fibrotic ulcer base, however, is technically difficult. A randomized controlled study comparing effectiveness of hemostasis among different hemostatic methods in canine models concluded that hemostatic clips were not effective due to the shape of the clips. The authors suggested that design modification could improve the effectiveness of clips [4]. With a larger jaw width and greater strength, the OTSC is expected to have improved outcomes. In 2007, Kirschniak et al. reported the first clinical experiences on the feasibility and safety of OTSCs for primary or postinterventional bleeding in the gastrointestinal tract, and for closure of iatrogenic full-thickness perforations [5]. All seven patients who received OTSC hemostasis recovered without rebleeding. In another series, which included 30 cases in which conventional endoscopic hemostasis had failed, the authors reported a 97 % success rate on primary hemostasis with two cases of rebleeding requiring repeated endoscopic hemostasis [6]. In the current study, a similar technical success rate of 100 % was reported for hemostasis with OTSCs, with two cases of rebleeding. One patient had a locally advanced cholangiocarcinoma and received radiotherapy after surgical resection. He developed rebleeding despite surgical plication. We speculate that the OTSC failed because the duodenal ulcer was chronically fibrotic due to residual tumor and previous radiotherapy, which rendered effective compression difficult. Three studies reported risk factors to ulcer rebleeding, including active bleeding upon endoscopy, size of bleeding artery larger than 2 mm, large ulcer size, posterior duodenal ulcer, as well as high lesser curvature ulcers [7 – 9]. In the current study, patients with complicated ulcers and underlying malignancies were recruited who were at a higher risk of rebleeding. In 8 /10 patients, the bleeding lesions were located in difficult positions, such as the postero-inferior wall of the first

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Use of the Over-The-Scope Clip for treatment of refractory upper gastrointestinal bleeding: a case series.

The Over-The-Scope Clip (OTSC; Ovesco, Tübingen, Germany) is a novel endoscopic clipping device designed for tissue approximation. The device has been...
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