Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title:

Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030769
• Other study ID #: 20130925-4
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: March 28, 2016
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Drug:
• Pronase
use pronase to improve visibility during endoscopical iodine staining
• Control
No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Disease	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases	Beijing Tide Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

References & Publications (5)

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; Société Française 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. — View 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. — View 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. — View 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. Epub 2007 Jun 15. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	observation time for esophagus		with 30 min after intubation	No
Primary	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	No
Secondary	Average Esophageal Visibility Score Before iodine staining		30 min after ingesting pretreatment solution	No
Secondary	Average Esophageal Visibility Score After iodine staining		within 5 min after iodine staining	No
Secondary	Detection Rate of lesions with pink sign		within 5 min after iodine staining	No
Secondary	overall detection rate of iodine void lesion		within 5 min after iodine staining	No