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

Introduction and aims The role of capsule endoscopy (CE) in patients with liver cirrhosis (LC) has yet to be established; however, it is likely that it will remain a valuable diagnostic modality in several groups of patients with LC. The primary aims of the current prospective interventional study are to examine the prevalence for small bowel lesions and transit time of CE in the gastrointestinal tract in patients with LC with oesophageal varices (EVs) requiring endoscopic therapies. Methods and analysis The current study will be a single-centre prospective interventional study. Our study participants are LC subjects with portal hypertension who were determined to be necessary for prophylactic endoscopic therapies for EVs. From the view point of safety, patients with gastrointestinal obstruction or fistula or those being suspected of having gastrointestinal obstruction or fistula will be excluded from our study. Patients with implanted medical devices will be also excluded. CE will be performed prior to prophylactic endoscopic therapies in the same hospitalisation and relevant images will be analysed after 8 hours by expert endoscopists. This study will continue to recruit until 50 participants. Ethics and dissemination This study has received approval from the Institutional Review Board at Hyogo College of Medicine (approval no. 2680). The study protocol, informed assent form and other submitted files were reviewed and acknowledged. Final data will be publicly scattered regardless of the study results. A report releasing study results will be submitted for publication in a suitable journal after being finished in data collection. Trial registration number UMIN000028433 (https://upload.umin.ac.jp/).