Digestive Endoscopy 2015; 27: 61–66

doi: 10.1111/den.12306

Original Article

Clinical usefulness of novel tag-less Agile patency capsule prior to capsule endoscopy for patients with suspected small bowel stenosis Masanao Nakamura,1 Yoshiki Hirooka,2 Takeshi Yamamura,1 Ryoji Miyahara,1 Osamu Watanabe,1 Takafumi Ando,1 Naoki Ohmiya3 and Hidemi Goto1 1

Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Department of Endoscopy, Nagoya University Hospital and 3Department of Gastroenterology, Fujita Health University, School of Medicine, Toyoake, Japan 2

Background and Aim: The Agile patency capsule (PC; Given Imaging Ltd, Yoqneam, Israel) is used as a dummy prior to capsule endoscopy (CE) to avoid retention of the CE capsule. However, impaction of the PC’s inner radio frequency identification (RFID) tag in a stricture could cause small-bowel ileus. Recently, the RFID tag-less PC was introduced into clinical practice. Herein, we aimed to retrospectively evaluate the usefulness of the tag-less PC. Methods: Of 154 patients who were scheduled to undergo CE, 100 consecutive patients (65%) who underwent PC evaluation were enrolled in the present study. Primary study end point was the retention rate of the CE capsule after successful passage of the PC. Secondary end point was analysis of the significant factors affecting the passage of the PC.

of these 87 patients during CE. Abnormal findings were obtained from 60 CE, and 41 patients received new or modified treatment. Multivariate analysis of factors related to the confirmation of patency demonstrated that stenosis on imaging was the most influential factor (P = 0.002, odds ratio 16.387). The results confirmed that passage of the PC depends on stenosis on imaging.

Conclusions: Use of the tag-less PC confirmed gastrointestinal tract patency for most of the patients who did not have stenosis on imaging and allowed estimation of the patency for patients who did have stenosis on imaging. Key words: capsule endoscopy, Crohn’s disease, patency capsule, retention, stenosis

Results: In total, 87 patients (87%) had bowel patency confirmed by PC evaluation. There was no capsule retention in any

INTRODUCTION

C

APSULE ENDOSCOPY (CE) is a promising tool for exploring the entire small bowel in a non-invasive manner to diagnose small bowel diseases. The most common indications for CE are obscure gastrointestinal (GI) bleeding, polyposis syndromes and evaluation of patients with complicated celiac disease.1–3 However, if the patient has a suspected small bowel stenosis caused by Crohn’s disease or a massive small bowel tumor, there is a risk of capsule

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Corresponding: Masanao Nakamura, Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, 65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan. Email: [email protected] Part of the results was presented at Digestive Disease Week 2014, 4–6 May, Chicago, IL, USA. Received 27 February 2014; accepted 2 April 2014.

retention during the CE procedure.4–6 In such a case, a patency capsule (PC), which is the same size as a CE capsule and is dissolvable, is likely to be used prior to diagnostic CE, and the usefulness of the PC technique has been reported.7–9 In addition, the PC system has been improved in a step-bystep process. The PC consists of lactose and 10% barium, which dissolve when intestinal fluids contact them through a window at the edge of the PC. Such an edge with a window is called a timer plug. Previous investigations have indicated problems with the first generation of PC, which had a single timer plug as an option on the PC body. There was a concern that the PC did not always dissolve readily in a long and tight stricture because the contents could not be exposed to intestinal fluids if the timer plug was impacted in the stricture. The next generation of PC was made with two timer plugs. The timer plugs at each end of the PC allows intestinal fluids, which contain lactase, to dissolve the capsule body even if the PC is impacted in the stricture. Herrerias et al. reported

© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society

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Figure 1 Tag-less patency capsule shown by computed tomography scan.

on 106 patients who ingested second-generation PC, and 59 (56%) patients excreted the PC intact and subsequently underwent CE. There were no cases of capsule retention in that study.10 PC also contain a radio frequency identification (RFID) tag, which is identified by a specific metal scanner. The RFID device is useful because patency can be checked without radiation exposure. However, impaction of the RFID tag in the stricture could cause small bowel ileus.11 The novel RFID tag-less Agile PC (Given Imaging Ltd, Yoqneam, Israel) was introduced into clinical practice in Japan in July 2012. This PC is the same as second-generation PC except that the RFID tag has been removed (Fig. 1). The aim of the present study was to retrospectively evaluate the usefulness of the new RFID tag-less Agile PC and to analyze the independent factors affecting favorable passage of the PC.

METHODS Patients

O

F 154 PATIENTS who were scheduled to undergo CE at Nagoya University Hospital between July 2012 and September 2013, 100 consecutive patients (65%) who underwent PC evaluation were enrolled. The indications for PC use in our hospital are the following: abdominal symptoms, including fullness and vague symptoms; stenosis on imaging; long-term use of non-steroidal anti-inflammatory drugs (NSAIDs); Crohn’s disease; chronic intestinal inflammatory diseases including radiation enteritis; known small bowel tumor; more than two abdominal surgeries; difficult balloon-assisted endoscopy (BAE); and a history of small bowel ileus. Exclusion criteria for the PC test were decided according to the health insurance treatment in Japan. They were patients who had a history of ileus or abdominal

Digestive Endoscopy 2015; 27: 61–66

surgery with difficulty to confirm safety to carry out this investigation with the other examinations required for small bowel disease, patients with pacemakers or other implanted electromedical devices, patients with swallowing disorder, and patients who the physician judged as inappropriate and allergic to barium. The PC procedure had two patterns based on the timing of PC swallowing, which was done in the morning or just before going to bed, the timing depending on the patient. The patient was free to have any food before and after PC injection. The patient did not take any medicine to motivate bowel movement for PC. Definition of the confirmation of patency of the GI tract was that the PC passed out of the body within 33 h, otherwise it was observed in the colon upon X-ray or computed tomography (CT) scan 33 h after PC swallowing. Once patency was confirmed, CE was scheduled within 1 week. Indications for PC use in 100 patients were Crohn’s disease (40 patients), abdominal symptoms (18), tumors (17), chronic intestinal diseases (16), NSAIDs use (3), ileus (3) and stenoses on imaging (3). All enrolled patients had undergone CT scan prior to the PC test. There were 46 plain and 54 enhanced CT scans. In addition, six of the patients with Crohn’s disease had double contrast enteroclysis. We regarded the factor, stenosis on imaging, as positive when the word, ‘stenosis’ in the small bowel was described in the report of CT or enteroclysis made by the radiologist and we agreed with it.

Methods Capsule endoscopy was done as described previously.12,13 Conceivable factors related to the confirmation of patency are shown in Table 1. Low activities of daily living (ADL) refer to a poor general condition as in a bedridden patient. Constipation is defined as a patient whose intervals of bowel opening were usually >3 days. The factor, ‘prokinetics’ refers to medicine routinely used for bowel movement disorder in daily clinical practice. The primary end point of the present study was the retention rate of the CE capsule in patients with confirmed GI tract patency. Secondary end points were identification of factors significantly related to the confirmation of patency and the excretion of an intact PC. This study was approved by the ethics committee of Nagoya University Hospital.

Statistical analysis The statistical software package SPSS for Windows (SPSS Inc., Chicago, IL, USA) was used to analyze the data. Univariate and multivariate logistic regression analyses were used to identify the factors related to the confirmation of

© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society

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Patency capsule for small bowel stenosis 63

Table 1 Factors related to the confirmation of 100 PC Factor

Value

Age (years) (mean ± SD) Gender (M/F) BMI (mean ± SD) In-/outpatient Low ADL Stenotic symptoms Stenosis on imaging modality Crohn’s disease Previous abdominal surgery Constipation Prokinetics Diabetes Injection timing (morning/night)

46.3 ± 19.4 59/41 20.6 ± 3.2 77/23 5 28 27 40 57 9 10 3 16/84

ADL, activities of daily living; BMI, body mass index; PC, patency capsule.

patency and the excretion of an intact PC. In all analyses, a P-value < 0.05 was considered statistically significant.

RESULTS

F

IGURE 2 SHOWS A flow diagram for the confirmation of patency according to the passage of the PC. Of the 100 patients who swallowed a PC, 53 (53%) excreted an intact PC within 33 h. The 47 patients with PC that were not excreted underwent imaging examinations. Based on abdominal X-rays or CT scans, there were 34 patients who had a PC in their colon or who had excreted the PC. Therefore, these 34

patients could also undergo CE. In total, patency was confirmed in 87 (87%) patients (Fig. 2). Of the 87 patients who underwent CE, 83 (95%) had entire small bowel observations within the examination period. In addition, there was no retention in any of the patients. The average interval between the PC procedure and CE was 1.3 days (0–7). Abnormal findings were obtained from 60 CE, and 41 patients received new or changed treatment (Table 2). Of the 40 patients with Crohn’s disease, 17 (42%) received modified treatment. To investigate the factors related to the confirmation of patency, we examined which factors listed in Table 1 significantly affected patency confirmation. Univariate analysis for the factors related to the confirmation of patency showed that abdominal symptoms, stenosis on imaging, lower ADL and PC swallowing time all significantly affected patency confirmation (Table 3). Multivariate analysis of these four factors indicated that stenosis on imaging was the most influential factor (P = 0.002, odds ratio 16.387) (Table 4). We also identified the factors related to the excretion of an intact PC in the 87 CE that were confirmed. Based on univariate analysis, stenosis on imaging and abdominal symptoms tended to be influential (Table 5). Multivariate analysis of these two factors indicated that stenosis on imaging was the most influential factor (P = 0.031, odds ratio 3.475) (Table 6). There were 13 patients whose PC did not confirm patency. Within this group, there were six Crohn’s disease patients who had a history of stricturoplasty or who had received balloon dilation by BAE for small bowel stenosis, three patients with small bowel tumors, two patients with other inflammatory bowel diseases and two post-ileus-status patients. Stenosis on imaging was detected in 11 patients

PC injection 100 Intact body excretion within 33 hours

Yes

No

53

47 Xp Out of body or in the colon

Suspected in the small bowel

20

27 CT

CE indication

In the colon

87

14

In the small bowel

13

No indication 13

Figure 2 Confirmation of patency according to the passage of the patency capsule (PC). CE, capsule endoscopy; CT, computed tomography; Xp, X-ray photography.

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Table 2 Capsule endoscopy findings Indication

Findings

Crohn’s disease

Ulcerations Scar, normal Erosion, aphtha Not indicated for CE

N



Treatment

17 15 13 0 4 2 6 0 Total 40 17 Abdominal Erosion 2 1 symptoms Bleeding 1 0 Duodenal ulcer 1 1 Normal 13 0 Not indicated for CE 1 0 Total 18 2 Tumors Malignant lymphoma 8 5 Others 4 4 Normal 2 0 Not indicated for CE 3 0 Total 17 9 Chronic intestinal Ischemic enteritis 2 2 disease Intestinal lymphangiectasia 2 2 Behçet’s disease 2 2 Intestinal tuberculosis 1 1 Lupus enteritis 1 1 Unknown erosion 2 0 Normal 4 0 Not indicated for CE 2 0 Total 16 8 NSAIDs users Ulcerations 2 2 Bleeding 1 1 Total 3 3 Ileus Normal 2 0 Not indicated for CE 1 0 Total 3 0 Stenosis on Ulcerations 2 2 imaging Angioectasia 1 0 Total 3 2 †

Treatment was introduced or changed by capsule endoscopy (CE) findings. NSAIDs, non-steroidal anti-inflammatory drugs.

(84.6%). The other two patients had histories of small bowel ileus. Subsequent BAE revealed the PC shell in front of the stricture in two of the eight patients who underwent BAE. They did not have any adverse events as a result of the shell.

DISCUSSION

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T IS CONTROVERSIAL as to whether imaging examinations can accurately predict GI tract patency for the safe passage of a subsequent CE. Current imaging techniques can identify long or medium stenosis of the GI tract with great reduction of the lumen size. However, short stenoses usually

Table 3 Univariate analysis of factors related to the confirmation of patency Factor

P-value

Odds ratio

95% CI

Gender Age BMI Crohn’s disease Abdominal symptoms Stenosis on imaging Constipation Prokinetics Admission Low ADL Injection time Post surgery

0.170 0.299 0.305 0.628 0.033

Clinical usefulness of novel tag-less Agile patency capsule prior to capsule endoscopy for patients with suspected small bowel stenosis.

The Agile patency capsule (PC; Given Imaging Ltd, Yoqneam, Israel) is used as a dummy prior to capsule endoscopy (CE) to avoid retention of the CE cap...
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