Ultrasound Capsule Endoscopy for Esophagus Examination

Overview

The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.

Full Title of Study: “Feasibility and Safety of Ultrasound Capsule Endoscopy for Esophagus Examination：a Pilot Study”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: May 30, 2022

Detailed Description

Wireless capsule endoscopy has opened a new era by enabling remote diagnostic assessment of the gastrointestinal tract in a painless procedure. However, most commercially available devices only utilise optical imaging to examine the GI wall surface. Using this sensing modality, pathology within the GI wall cannot be detected. Micro-ultrasound (mUS) using high-frequency (>20 MHz) ultrasound can provide a means of transmural or cross-sectional image of the GI tract. Depth of imaging is approximately 10 mm with a resolution of between 40-120 μm that is sufficient to differentiate between subsurface histologic layers of the various regions of the GI tract. Ultrasound capsule endoscopy (USCE) uses a capsule equipped with mUS transducers that are capable of imaging below the GI wall surface, offering thereby a complementary sensing technique to optical imaging capsule endoscopy. In this work, a USCE device integrated with a 40 MHz ultrasonic transducer was developed to capture a full 360˚ image of the lumen. Previous animal studies of two anaesthetised Landrace pigs have demonstrated the effectiveness of the device. The reconstructed images demonstrate clear layer differentiation of the lumen wall. The tissue thicknesses measured from the B-scan images show good agreement with ex vivo images from the literature. The aim of this pilot study is to assess the feasibility and safety of the clinical application of ultrasound capsule endoscopy in esophageal examination compared with conventional endoscopic ultrasound examination.

Interventions

• Other: ultrasound capsule endoscopy
  • Healthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks.

Arms, Groups and Cohorts

• Other: ultrasound capsule endoscopy examination
  • Healthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks.

Clinical Trial Outcome Measures

Primary Measures

• Success rate of esophageal examination
  • Time Frame: 1 month
  • Assess the success rate of the clinical application of ultrasound capsule endoscopy in esophageal examination, including observe the mucosa completely and obtain ultrasound cross-sectional images in specific parts.

Secondary Measures

• Diagnostic accuracy
  • Time Frame: 1 month
  • The diagnostic accordance rate, sensitivity and specificity of lesions detected by ultrasound capsule endoscopy compared with conventional endoscopic ultrasound examination.
• Clear layer differentiation of the esophageal wall structure
  • Time Frame: 1 month
  • Assess the success rate of clear layer differentiation of the esophageal wall structure by ultrasound capsule endoscopy examination
• Safety of ultrasound capsule endoscopy examination
  • Time Frame: 1 month
  • The presence of any adverse events during ultrasound capsule endoscopy examination procedure will be recorded.
• Examination time of esophagus
  • Time Frame: 1 month
  • Record the time taken to finish examination of esophagus under ultrasound capsule endoscopy.
• Discomfort scores associated with ultrasound capsule endoscopy examination
  • Time Frame: 1 month
  • Assess the discomfort score caused by the string, swallowing the ultrasound capsule, pulling the capsule up or down, and pulling the capsule out. A visual analogue scale ranging from 0 (easy with no nausea) to 10 (very difficult or with sever nausea) was used to evaluate the degree of difficulty of the discomfort score caused by the string.

Participating in This Clinical Trial

Inclusion Criteria

1. Participants aged 18 years or older. 2. Both inpatients and outpatients. 3. Healthy volunteers or patients with suspected esophageal disease 4. Able to provide informed consent. Exclusion Criteria:

1. known or suspected complex history of gastrointestinal obstruction, stenosis or fistula. 2. dysphagia. 3. known or suspected possibility of active bleeding of digestive tract. 4. Pregnancy or suspected pregnancy.. 5. Patients who have participated in or are participating in other clinical trials within three months. 6. Life-threatening conditions. 7. other circumstances that doctors consider inappropriate for the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Changhai Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Zhuan Liao, Professor – Changhai Hospital
• Overall Official(s)
  • Zhuan Liao, Professor, Principal Investigator, Changhai Hospital,Shanghai,China
• Overall Contact(s)
  • Zhuan Liao, Professor, (81)02131161024, zhuanleo@126.com

References

Thosani N, Singh H, Kapadia A, Ochi N, Lee JH, Ajani J, Swisher SG, Hofstetter WL, Guha S, Bhutani MS. Diagnostic accuracy of EUS in differentiating mucosal versus submucosal invasion of superficial esophageal cancers: a systematic review and meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):242-53. doi: 10.1016/j.gie.2011.09.016. Epub 2011 Nov 23.

Qiu Y, Huang Y, Zhang Z, Cox BF, Liu R, Hong J, Mu P, Lay HS, Cummins G, Desmulliez MPY, Clutton E, Zheng H, Qiu W, Cochran S. Ultrasound Capsule Endoscopy With a Mechanically Scanning Micro-ultrasound: A Porcine Study. Ultrasound Med Biol. 2020 Mar;46(3):796-804. doi: 10.1016/j.ultrasmedbio.2019.12.003. Epub 2020 Jan 3.

Ughi GJ, Gora MJ, Swager AF, Soomro A, Grant C, Tiernan A, Rosenberg M, Sauk JS, Nishioka NS, Tearney GJ. Automated segmentation and characterization of esophageal wall in vivo by tethered capsule optical coherence tomography endomicroscopy. Biomed Opt Express. 2016 Jan 8;7(2):409-19. doi: 10.1364/BOE.7.000409. eCollection 2016 Feb 1.