Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

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.

Timeline

Start

2014-01

Primary completion

2014-12

Completion

2014-12

Outcome

Met primary endpoint

paper detection rate of ESCC (confirmed by histopathology) was significantly higher in the pronase group than in the control group PMID 36781469 ↗

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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