Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
Study NCT ID:
NCT02030769
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2014-01-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011402', 'term': 'Pronase'}], 'ancestors': [{'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D057057', 'term': 'Serine Proteases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'observation time for esophagus', 'timeFrame': 'with 30 min after intubation'}], 'primaryOutcomes': [{'measure': 'Detection rate of high grade dysplasia and carcinoma in iodine void lesion', 'timeFrame': '1 week', 'description': 'Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）\\*100%'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophageal Neoplasms', "Lugol's solution", 'Pronase', 'Endoscopy, Digestive System', 'Pretreatment method'], 'conditions': ['Esophageal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '22267978', 'type': 'BACKGROUND', '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.'}, {'pmid': '21796615', 'type': 'BACKGROUND', '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.'}, {'pmid': '16874909', 'type': 'BACKGROUND', '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."}, {'pmid': '18718584', 'type': 'BACKGROUND', '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.'}, {'pmid': '17573830', 'type': 'BACKGROUND', '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.'}, {'pmid': '36781469', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 60 years to 75 years old\n* 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.\n\nExclusion Criteria:\n\n* Allergy to iodine or any other medicine which used in this trial.\n* Previous endoscopy revealing advanced esophageal cancer or other non-superficial lesions.\n* Conditions interfering visibility of endoscope including gastrointestinal obstruction and upper gastrointestinal bleeding.\n* Anatomic variation by surgery.\n* Pregnancy\n* Other conditions which investigator consider the patient at high risk for complications.'}, 'identificationModule': {'nctId': 'NCT02030769', 'briefTitle': 'Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer', 'orgStudyIdInfo': {'id': '20130925-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pronase', 'description': 'Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.', 'interventionNames': ['Drug: Pronase']}, {'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'Pronase', 'type': 'DRUG', 'description': 'use pronase to improve visibility during endoscopical iodine staining', 'armGroupLabels': ['Pronase']}, {'name': 'Control', 'type': 'DRUG', 'description': 'No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital of Digestive Disease', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Kaichun Wu, Ph.D. & M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xijing Hospital of Digestive DIsease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tide Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zhiguo Liu', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}