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Clinical study of optical coherence tomography (OCT)-assisted gastrointestinal endoscopy in real-time imaging and diagnosis of early esophageal cancer

Clinical study of optical coherence tomography (OCT)-assisted gastrointestinal endoscopy in real-time imaging and diagnosis of early esophageal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083587
Enrollment
Unknown
Registered
2024-04-29
Start date
2024-04-29
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early esophageal cancer

Interventions

Sponsors

Department of Gastroenterology, Second Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients who meet the requirements of Article 1 and any of Articles 2-5 can be included: (1) aged 40-75 years old, male or female; (2) people in areas with high incidence of esophageal cancer; (3) previous pre-cancerous or precancerous esophageal diseases such as chronic esophagitis, Barrett's esophagus, esophageal mucosal leukomalacia, esophageal diverticulum, pancreatic achalasia, reflux esophagitis, etc.; (4) first-degree relatives of patients with esophageal cancer; and (5) the presence of other high-risk factors for esophageal cancer: preference of high-temperature and pickled foods, eating too fast, Smoking, heavy drinking (=15g/d), missing teeth, etc.

Exclusion criteria

Exclusion criteria: (1) Patients who have undergone surgical resection of esophagus, percutaneous endoscopic gastrostomy (PEG), chemotherapy and other invasive treatments (except for endoscopic treatment ); (2) Patients with TMN classification of carcinoma that meets the diagnosis of progressive carcinoma of T2 or above; (3) Patients who cannot be biopsied if they have taken anticoagulants, antiplatelets, or blood activating drugs within two weeks; (4) Women with PPI or H2 receptor antagonist; (5) patients with a history of malignant tumors or severe cardiac, pulmonary, hepatic or renal insufficiency, or severe mental disorders, etc.; (6) women who are pregnant or breastfeeding; and (7) those who are unable to cooperate with the examination and have not signed the informed consent form.

Design outcomes

Primary

MeasureTime frame
Accuracy;negative predictive value;Kappa value;

Secondary

MeasureTime frame
Sensitivity;specificity;positive predictive value;

Countries

China

Contacts

Public ContactDou weijia

Department of Gastroenterology, Second Affiliated Hospital of Air Force Medical University

weijia_dou@126.com+86 187 9273 9164

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026