Efficacy of Endoscopy Screening on Esophageal Cancer in China (ESECC)

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic Screening: 1. Upper G.I. endoscopic examination with Lugols Iodine in esophagus 2. Biopsy at the visually abnormal sites 3. Pathologic examination of all biopsy tissue specimens 4. Subsequent re-examination and further medical services among individuals who already have high-grade lesions found at screening. 5. Advises of endoscopic or surgical treatment will be given to participants who are diagnosed of high grade upper G.I. lesions.

Study summary

To evaluate the efficacy of endoscopic screening on esophageal cancer (EC) and determine the most cost-effective strategy of endoscopic screening in high risk population in China, 668 villages of Hua county, a high risk area of esophageal cancer, were randomized into screening arm and control arm in a ratio of 1:1 and the total sample size is over 32,000 (\~16,000 per group). Participants in the screening arm will accept standard chromoendoscopy examination to detect early esophageal cancer and no screening were designed in the control arm. The incidence of advanced EC, EC-specific mortality and all-cause mortality will be compared within the two groups to test the hypothesis that endoscopic screening would alter the natural history of lesions in esophagus and the incidence of advanced stage EC, EC-specific mortality and all-cause mortality in the screening arm will be lower than the control group. Cost-effectiveness analysis will also be conducted to find the most cost-effective strategy of endoscopic screening in rural China.

Eligibility

Primary outcome measure(s)

• Esophageal cancer specific mortality — 5-10 years
• Cost for saving 1 quality-adjusted life year (QALY) — 5-10 years

Trial sites (1)

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