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| Name | Class |
|---|---|
| Beijing Tide Pharmaceutical Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pronase | Experimental | Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate. |
|
| control | Sham Comparator | No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pronase | Drug | use pronase to improve visibility during endoscopical iodine staining |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of high grade dysplasia and carcinoma in iodine void lesion | Detection Rate=(lesions with confirmed high grade dysplasia/all iodine void lesions)*100% | 1 week |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| observation time for esophagus | with 30 min after intubation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaichun Wu, Ph.D. & M.D. | Xijing Hospital of Digestive DIsease | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22267978 | Background | Lopes AB, Fagundes RB. Esophageal squamous cell carcinoma - precursor lesions and early diagnosis. World J Gastrointest Endosc. 2012 Jan 16;4(1):9-16. doi: 10.4253/wjge.v4.i1.9. | |
| 21796615 | Background | Yokoyama A, Hirota T, Omori T, Yokoyama T, Kawakubo H, Matsui T, Mizukami T, Mori S, Sugiura H, Maruyama K. Development of squamous neoplasia in esophageal iodine-unstained lesions and the alcohol and aldehyde dehydrogenase genotypes of Japanese alcoholic men. Int J Cancer. 2012 Jun 15;130(12):2949-60. doi: 10.1002/ijc.26296. Epub 2011 Sep 16. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011402 | Pronase |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Control |
| Drug |
No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine 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 |
| 16874909 | Background | Dubuc J, Legoux J-, Winnock M, Seyrig J-, Barbier J-, Barrioz T, Laugier R, Boulay G, Grasset D, Sautereau D, Grigoresco D, Butel J, Scoazec J-, Ponchon T; Societe Francaise d'Endoscopie Digestive. Endoscopic screening for esophageal squamous-cell carcinoma in high-risk patients: a prospective study conducted in 62 French endoscopy centers. Endoscopy. 2006 Jul;38(7):690-5. doi: 10.1055/s-2006-925255. |
| 18718584 | Background | Ishihara R, Yamada T, Iishi H, Kato M, Yamamoto S, Yamamoto S, Masuda E, Tatsumi K, Takeuchi Y, Higashino K, Uedo N, Tatsuta M, Ishiguro S. Quantitative analysis of the color change after iodine staining for diagnosing esophageal high-grade intraepithelial neoplasia and invasive cancer. Gastrointest Endosc. 2009 Feb;69(2):213-8. doi: 10.1016/j.gie.2008.04.052. Epub 2008 Aug 20. |
| 17573830 | Background | Shimizu Y, Omori T, Yokoyama A, Yoshida T, Hirota J, Ono Y, Yamamoto J, Kato M, Asaka M. Endoscopic diagnosis of early squamous neoplasia of the esophagus with iodine staining: high-grade intra-epithelial neoplasia turns pink within a few minutes. J Gastroenterol Hepatol. 2008 Apr;23(4):546-50. doi: 10.1111/j.1440-1746.2007.04990.x. Epub 2007 Jun 15. |
| 36781469 | Derived | Zhao X, Guo M, Zhu S, Zhang L, Dong T, Luo H, Yu W, Zhu J, Fan X, Han Y, Liu Z. Pre-procedure oral administration of pronase improves efficacy of lugol chromoendoscopy in esophageal squamous cell carcinoma screening: a prospective, double-blinded, randomized, controlled trial. Surg Endosc. 2023 Jun;37(6):4421-4430. doi: 10.1007/s00464-023-09902-1. Epub 2023 Feb 13. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D012697 | Serine Endopeptidases |
| D045726 | Metalloproteases |
| D057057 | Serine Proteases |