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Efficacy of Capsule Endoscopy in Patients with Cirrhosis for The Endoscopy BMJ Open Gastroenterol: first published as 10.1136/bmjgast-2017-000168 on 14 September 2017. Downloaded from Efficacy of capsule endoscopy in patients with cirrhosis for the diagnosis of upper gastrointestinal lesions and small bowel abnormalities: a study protocol for prospective interventional study Yoshinori Iwata,1 Hiroki Nishikawa,1,2 Hirayuki Enomoto,1 Kazunori Yoh,1 Akio Ishii,1 Yukihisa Yuri,1 Noriko Ishii,1 Yuho Miyamoto,1 Kunihiro Hasegawa,1 Chikage Nakano,1 Ryo Takata,1 Takashi Nishimura,1 Nobuhiro Aizawa,1 Yoshiyuki Sakai,1 Naoto Ikeda,1 Tomoyuki Takashima,1 Hiroko Iijima,1 Shuhei Nishiguchi1,2 To cite: Iwata Y, Nishikawa H, ABSTRACT INTRODUCTION Protected by copyright. Enomoto H, et al. Efficacy of Introduction and aims The role of capsule endoscopy Portal hypertension (PH) is a frequent capsule endoscopy in patients (CE) in patients with liver cirrhosis (LC) has yet to be manifestation in patients with liver cirrhosis with cirrhosis for the diagnosis established; however, it is likely that it will remain of upper gastrointestinal (LC), and PH is associated with various a valuable diagnostic modality in several groups of lesions and small bowel pathological changes in the entire gastro- patients with LC. The primary aims of the current abnormalities: a study protocol intestinal tract.1–4 PH-related changes in prospective interventional study are to examine the for prospective interventional the oesophagus, stomach, duodenum and study. BMJ Open Gastro prevalence for small bowel lesions and transit time of CE in the gastrointestinal tract in patients with LC colon are well described in the previous 2017;4:e000168. doi:10.1136/ 1 4–7 bmjgast-2017-000168 with oesophageal varices (EVs) requiring endoscopic reports. In Japan, endoscopic therapies therapies. are central for the management of oesoph- Received 2 August 2017 Methods and analysis The current study will be ageal varices (EVs), which is regarded as a Revised 10 August 2017 a single-centre prospective interventional study. major complication of LC.8–10 The standard Accepted 14 August 2017 Our study participants are LC subjects with portal endoscopic therapies for EVs in Japan are hypertension who were determined to be necessary endoscopic injection sclerotherapy (EIS) http://bmjopengastro.bmj.com/ for prophylactic endoscopic therapies for EVs. From and endoscopic band ligation (EBL).1 11 12 the view point of safety, patients with gastrointestinal Portal hypertensive gastroenteropathy obstruction or fistula or those being suspected of (PHG) remains difficult to diagnose in having gastrointestinal obstruction or fistula will be excluded from our study. Patients with implanted patients with LC, with PH and limited medical devices will be also excluded. CE will diagnostic choices exist for the investi- be performed prior to prophylactic endoscopic gation of the small bowel in patients with 13 therapies in the same hospitalisation and relevant LC. Capsule endoscopy (CE) is currently images will be analysed after 8 hours by expert available as a minimally invasive imaging endoscopists. This study will continue to recruit until procedure which contributes signifi- 50 participants. cantly to the identification of small bowel on September 25, 2021 by guest. Ethics and dissemination This study has received abnormalities.14–16 CE revolutionised the 1Division of Hepatobiliary and approval from the Institutional Review Board at Hyogo evaluation for patients with obscure gastro- Pancreatic disease, Department College of Medicine (approval no. 2680). The study of Internal Medicine, intestinal bleeding because it allows reliable protocol, informed assent form and other submitted Hyogo College of Medicine, and non-invasive visibility of the mucosal files were reviewed and acknowledged. Final data will Nishinomiya, Japan surface in small bowels. Since 2001, CE has 2 be publicly scattered regardless of the study results. Center for Clinical Research evolved into helpful diagnostic technology and Education, Hyogo College of A report releasing study results will be submitted for 14–16 Medicine, Nishinomiya, Japan publication in a suitable journal after being finished in integrated in daily clinical practice. On data collection. the other hand, with the progression of LC, Correspondence to Trial registration number UMIN000028433 (https:// the peristaltic movement of the gastroin- Dr Hirayuki Enomoto; upload. umin. ac. jp/). testinal tract is expected to decrease due enomoto@ hyo- med. ac. jp Iwata Y, et al. BMJ Open Gastro 2017;4:e000168. doi:10.1136/bmjgast-2017-000168 1 Open Access BMJ Open Gastroenterol: first published as 10.1136/bmjgast-2017-000168 on 14 September 2017. Downloaded from 7. Patients who are unable to receive open surgery. 8. Patients who were judged to be inappropriate for the study subjects. STUDY PROTOCOL ► Study design: single-arm and open-label trial. Our study participants are LC subjects with PH who were determined to be necessary for prophylactic endo- scopic therapies for EVs. LC will be mainly determined by radiological findings such as CT and ultrasound (defor- mity of the liver surface, the presence of ascites, atrophy of the right lobe and/or compensatory swelling of the left lobe) and/or pathological findings. The current study will be a single-centre prospective interventional study. We will prospectively register appropriate candidates. Figure 1 Study design. CAPSULE ENDOSCOPY to PHG, which may lead to the delay in excretion of The CE is disposable and is naturally discharged at the capsule endoscopy.5 17–19 Small bowel capsule endos- time of defaecation. CE will be performed with a video copy (SBCE) has been utilised to characterise PHG capsule endoscopy device (PillCam SB2 plus capsule; and is valuable for the diagnosis of this condition in Given Imaging, Tokyo, Japan) prior to prophylactic patients with LC who continue to bleed despite endo- endoscopic therapies for EVs. CE and prophylactic scopic treatment for EVs. The role of SBCE in PHG endoscopic therapies of EVs for each participant will has yet to be established; however, it is likely that it will be performed in the same hospitalisation. Study partic- Protected by copyright. remain a valuable diagnostic modality in several groups ipants will swallow the capsule in a sitting position with a of patients with LC.11–13 In addition, the sensitivity of solution of dimethicone after an overnight fast, without CE is not currently sufficient to replace oesophago- 25–27 any other preparation. After 2 hours from swallowing gastroduodenoscopy (EGD) as a first exploration for of the capsule, participants will be allowed to drink clear patients with LC; however, given its high accuracy, it liquids. After 4 hours from swallowing of the capsule, may have a certain role in patients with LC with refusal participants will be allowed to eat a light meal. After or contraindication for EGD.20–24 8 hours, the sensor array and recording device will be Considering these backgrounds, in the current prospec- removed and images will be analysed. Two expert endos- tive interventional study, we will primarily aim to examine copists will make diagnoses after reaching an agreement the prevalence for small bowel lesions and transit time of with each other (figure 1). CE in the gastrointestinal tract in patients with LC with EVs requiring endoscopic therapies. Primary endpoints 1. Prevalence for small bowel lesions (small bowel lesions http://bmjopengastro.bmj.com/ PATIENT ELIGIBILITY CRITERIA will be defined as follows: (a) vascular lesion or (b) The inclusion criteria for this study are as follows: ulcerative lesion). Tumour lesion will not be included 1. Gender is not limited. for small bowel lesions in this study. 2. Patients aged 18 years or more. 2. Transit time of CE in the gastrointestinal tract 3. Patients with PH who were determined to be necessary (oesophagus, stomach, duodenum and small bowel). for prophylactic endoscopic therapies for EVs such as Secondary endpoints EIS and EBL. 1. Detection rate by capsule endoscopy for upper gastro- Patients will be excluded if they meet one or more of intestinal lesions (upper gastrointestinal lesions will be the following criteria. defined as upper gastrointestinal varices or mucosal on September 25, 2021 by guest. 1. Patients aged less than 18 years. lesions whose presence was confirmed by EGD). 2. Patients with gastrointestinal obstruction or fistula or those being suspected of having gastrointestinal ob- struction or fistula. PROPHYLACTIC ENDOSCOPIC THERAPIES FOR EVS 3. Patients with gastrointestinal stenosis in whom CE will Our protocol for prophylactic therapies for EVs is as be remained in the same place. reported previously.28 Briefly, in our department, for 4. Patients with cardiac pacemakers or other implanted patients with EVs positive for red colour signs or F2 or medical devices. more EVs (medium or large varices), prophylactic endo- 5. Patients with dysphagia. scopic therapies will be in general considered. In patients 6. Patients in whom consents for removal of remained with LC with Child-Pugh A, EIS monotherapy or EIS CE are unable to be obtained. and EBL combination therapy will be selected, while in 2 Iwata Y, et al. BMJ Open Gastro 2017;4:e000168. doi:10.1136/bmjgast-2017-000168 Open Access BMJ Open Gastroenterol: first published as 10.1136/bmjgast-2017-000168 on 14 September 2017. Downloaded from patients with Child-Pugh B or C such as cases with severe DISCUSSION ascites or hyperbilirubinaemia, EBL monotherapy will be Gastroenteropathy is a lesser recognised complication in chosen. Follow-up endoscopy after prophylactic endo- patients with PH and consists of different changes in the scopic therapies will be considered after 1–3 months, and mucosa of the small bowel which result in the appearance when eradication of EVs is incomplete, supplementary of vascular and inflammatory abnormalities.32 It can be therapies will be carried out.28 a key factor for the development of anaemia in patients with LC, and recently an easy and non-invasive diagnosis is able to be made by CE. However, it is rarely considered 32–34 EXPECTED RISK FOR STUDY paRTICipaNTS for the management of patients with PH.
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