Clinical trial NCT02030769: Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Official title: Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasms
Keywords: Esophageal Neoplasms
Lugol's solution
Pronase
Endoscopy, Digestive System
Pretreatment method
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
Collaborators: name: Beijing Tide Pharmaceutical Co., Ltd
First posted: 2014-01-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Detection rate of high grade dysplasia and carcinoma in iodine void lesion
timeFrame: 1 week
Secondary outcomes:
measure: Average Esophageal Visibility Score Before iodine staining
timeFrame: 30 min after ingesting pretreatment solution
measure: Average Esophageal Visibility Score After iodine staining
timeFrame: within 5 min after iodine staining
measure: Detection Rate of lesions with pink sign
timeFrame: within 5 min after iodine staining
measure: overall detection rate of iodine void lesion
timeFrame: within 5 min after iodine staining
Other outcomes:
measure: observation time for esophagus
timeFrame: with 30 min after intubation
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Disease
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive DIsease
name: Kaichun Wu, Ph.D. & M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.