Clinical trial NCT05054933: Ultrasound Capsule Endoscopy for Esophagus Examination
Official title: Feasibility and Safety of Ultrasound Capsule Endoscopy for Esophagus Examination：a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Diseases
Keywords: capsule endoscopy; ultrasound
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Success rate of esophageal examination
timeFrame: 1 month
Secondary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 month
measure: Clear layer differentiation of the esophageal wall structure
timeFrame: 1 month
measure: Safety of ultrasound capsule endoscopy examination
timeFrame: 1 month
measure: Examination time of esophagus
timeFrame: 1 month
measure: Discomfort scores associated with ultrasound capsule endoscopy examination
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital,Shanghai,China
name: Zhuan Liao, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.