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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02030769
Other study ID # 20130925-4
Secondary ID
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


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
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