Esophageal Neoplasms
Conditions
Keywords
Esophageal Neoplasms, Lugol's solution, Pronase, Endoscopy, Digestive System, Pretreatment method
Brief summary
Lugol's solution staining was regarded as a gold standard to detect early superficial lesion during esophageal cancer screening using endoscopy. However, the sensitivity and specificity were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was previously shown to improve the visibility of gastrointestinal tract. It's unknown if the pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A randomized double-blind clinical trial was designed to investigate whether or not pronase might improve detection rate of early esophageal lesion, especially high grade dysplasia and early cancer by improving the esophageal visibility.
Interventions
DRUGPronase
use pronase to improve visibility during endoscopical iodine staining
DRUGControl
No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining
Sponsors
Beijing Tide Pharmaceutical Co., Ltd
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients 60 years to 75 years old * Patients less than 60 years old, but with one or multiple high risk factors for esophageal cancer including smoking and drinking addiction,family history of esophageal cancer, personal history of esophageal or head and neck malignancies, previous endoscopy documenting iodine void superficial lesion.
Exclusion criteria
* Allergy to iodine or any other medicine which used in this trial. * Previous endoscopy revealing advanced esophageal cancer or other non-superficial lesions. * Conditions interfering visibility of endoscope including gastrointestinal obstruction and upper gastrointestinal bleeding. * Anatomic variation by surgery. * Pregnancy * Other conditions which investigator consider the patient at high risk for complications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of high grade dysplasia and carcinoma in iodine void lesion | 1 week | Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）\*100% |
Secondary
| Measure | Time frame |
|---|---|
| Average Esophageal Visibility Score Before iodine staining | 30 min after ingesting pretreatment solution |
| Average Esophageal Visibility Score After iodine staining | within 5 min after iodine staining |
| Detection Rate of lesions with pink sign | within 5 min after iodine staining |
| overall detection rate of iodine void lesion | within 5 min after iodine staining |
Other
| Measure | Time frame |
|---|---|
| observation time for esophagus | with 30 min after intubation |
Countries
China
Outcome results
None listed