Establishment of Image Database for Early Upper Gastrointestinal Cancer, Precancerous Lesions, and Precancerous Conditions

NCT07462247 — Recruiting, 500 participants, Changhai Hospital

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RegistryNCT07462247
StatusRecruiting
Study typeObservational
Enrollment500 (Estimated)
SponsorChanghai Hospital (Other)
ConditionsUpper Gastrointestinal Cancer, Upper Gastrointestinal Precancerous Lesions, Upper Gastrointestinal Precancerous Conditions
Interventionsmagnetically-controlled capsule endoscopy, esophagogastroduodenoscopy, CT scan, ESD, biopsy (Diagnostic test, procedure)
Datesstart 2026-03-11, primary completion 2030-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-03-10, last updated 2026-03-12
Locations1 site in China

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-Summary

The study is designed to collect magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, CT images, and histopathology results to establish a database for early upper gastrointestinal cancer, precancerous lesions, and precancerous conditions.

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+Detailed description

Images of MCE for UGIC are scarce, limiting the development of corresponding AI diagnostic model. We aim to create an image database with MCE images, EGD images, CT images, and histopathology results, in patients treated by ESD for early upper gastrointestinal cancer, or biopsy for precancerous lesions, and precancerous conditions, so as to facilitate image-based deep learning studies.

+Arms and interventions

  • magnetically-controlled capsule endoscopy, esophagogastroduodenoscopy, CT scan (Diagnostic test): Magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, and CT images for early upper gastrointestinal cancer, precancerous lesions, and precancerous conditions
  • ESD, biopsy (Procedure): ESD or biopsy for histopathology results

+Outcome measures

Primary outcomes

  • Magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, and CT images [Prior to ESD or biopsy]
  • Histopathology results [During ESD or biopsy]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Male or female participants aged ≥ 18 years
2. Patients with early upper gastrointestinal cancer referred for endoscopic submucosal dissection (ESD), or patients with upper gastrointestinal precancerous lesions or precancerous conditions referred for biopsy by esophagogastroduodenoscopy (EGD)
3. Participants who are willing and able to participate in this study, complete all required examinations and follow-up visits, and who have provided written informed consent

Exclusion Criteria:

1. Patients who are not eligible for surgery or who refuse any abdominal surgery in case of capsule retention and endoscopic retrieval failure
2. Patients with cardiac pacemaker or other implanted electromedical devices which could interfere with magnetic resonance
3. Suspected or known intestinal stenosis or other known risk factors for capsule retention
4. Patients with dysphagia
5. Pregnancy
6. Allergy to polymeric materials, latex, simethicone, or pronase
7. Patients plan to undergo magnetic resonance imaging examination before excretion of the capsule
8. Patients with any condition that precludes compliance with the study

+Locations (1)

FacilityCityCountryStatus
Changhai HosptialShanghaiChinaRecruiting

+Investigators