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Endoscopic Screening on Esophageal Cancer

Effect of Endoscopic Screening on Esophageal Cancer Incidence and Mortality: 10-year Follow up of a Community-based, Controlled Study Among High Risk Population in China

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02094105
Enrollment
45386
Registered
2014-03-21
Start date
1999-11-30
Completion date
2013-12-31
Last updated
2014-03-21

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

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal cancer, screening, endoscopy, prevention

Brief summary

Importance: There are no global screening recommendations for esophageal squamous cell carcinoma (ESCC). Endoscopic screening has been investigated in high incidence areas of China since 1970's. But up until now there no apparent evidence that would lead to a reduction in disease morbidity and mortality. Objective: To evaluate whether endoscopic screening and early intervention program could reduce the incidence or mortality of ESCC. Design: Community-based, controlled cohort study among 45 386 residents, Endoscopy screening was completed from November 1999 to May of 2000. Subjects in intervention group were examined once during intervention period. The study follow-up concluded in December 2009. Setting: High risk area of ESCC in China Participants:Cluster sampling from communities with high rates of esophageal cancer. A set of villages with was selected as the study intervention community. Age 40 to 69 years residents were selected as an eligible population. Another set of villages was select as the control population. Buffer villages were set up between intervention and control group. Intervention: Endoscopy with Lugol's iodine staining and early treatment on precancerous lesions was undergone for the intervention group. Main Outcome(s) and Measure(s): Incidence and mortality ESCC

Interventions

PROCEDUREEndoscopy examination with iodine staining

Endoscopy examination with Lugol's iodine staining and questionnaire once time and early treatment on precancerous lesions was undergone for the intervention group.

Sponsors

Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
Yes

Inclusion criteria

* local residents * Men and women aged 40 to 69 years * no contraindications for endoscopic examinations (e.g. history of reaction of iodine or lidocaine), and who were mentally and physically competent to provide written informed consent. * informed consent

Exclusion criteria

* Not local residents * age younger than 40 yrs and older than 69 yrs * History of reaction of iodine or lidocaine * contraindications for endoscopic examinations

Design outcomes

Primary

MeasureTime frame
incidence and mortality of ESCC10 years

Secondary

MeasureTime frame
Cumulative incidence and mortality of total cancer, and gastric cardia cancer10 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026