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A multicenter clinical study for the efficacy and safety of esophageal mucosa staining kit in the diagnosis of early esophageal cancer and precancerous lesions

A multicenter clinical study for the efficacy and safety of esophageal mucosa staining kit in the diagnosis of early esophageal cancer and precancerous lesions

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028081
Enrollment
Unknown
Registered
2019-12-11
Start date
2014-10-28
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Esophageal Cancer

Interventions

Gold Standard:Endoscopic iodization staining and indicative biopsy are the best methods for early diagnosis of esophageal cancer.
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Sponsors

The Second Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years old, men and women; (2) There are the following high-risk factors or one of the following esophageal cancer factors: local mucosa color change, mucous membrane thickening, turbidity and vascular structure disorders, mucosa culture, plaque, there are knots and mucous membrane rough; (3) Those who voluntarily participate in this experiment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with iodine allergy or hyperthyroidism; (2) Routine endoscopic examination for typical progressive esophageal cancer, Barrett's esophagus; (3) Patients with serious diseases such as heart, brain and lung; (4) patients with post-pharynx wall abscesses, severe spinal malformations, or aortic aneurysms; (5) the acute stage of corrosive inflammation of the upper digestive tract, or suspected perforation of the upper digestive tract; (6) Large amounts of abdominal water, severe bloating, or those with severe esophageal varicose veins; (7) Pregnant and lactating women; (8) Those who have a tendency to bleed or are taking anticoagulant drugs; (9) A person who is deemed not to be fit to participate in this clinical trial; (10) Pathological biopsy was diagnosed with esophageal adenocarcinoma.

Design outcomes

Primary

MeasureTime frame
Positive rate;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
Quality of edge of the lesion;

Countries

China

Contacts

Public ContactLin Miao

Second Affiliated Hospital of Nanjing Medical University

nydefyll@163.com+86 18951762836

Outcome results

None listed

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