NCT02030769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

January 6, 2014

Last Update Submit

March 28, 2016

Conditions

Esophageal Neoplasms

Keywords

Esophageal NeoplasmsLugol's solutionPronaseEndoscopy, Digestive SystemPretreatment method

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Average Esophageal Visibility Score Before iodine staining

    30 min after ingesting pretreatment solution

  • Average Esophageal Visibility Score After iodine staining

    within 5 min after iodine staining

  • Detection Rate of lesions with pink sign

    within 5 min after iodine staining

  • overall detection rate of iodine void lesion

    within 5 min after iodine staining

Other Outcomes (1)

  • observation time for esophagus

    with 30 min after intubation

Study Arms (2)

Pronase

EXPERIMENTAL

Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

Drug: Pronase

control

SHAM COMPARATOR

No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

Drug: Control

Interventions

PronaseDRUG

use pronase to improve visibility during endoscopical iodine staining

Pronase
ControlDRUG

No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining

control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Related Publications (6)

  • 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: 22267978BACKGROUND

  • 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: 21796615BACKGROUND

  • 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: 16874909BACKGROUND

  • 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: 18718584BACKGROUND

  • 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: 17573830BACKGROUND

  • 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.

    PMID: 36781469DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Pronase

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine EndopeptidasesMetalloproteasesSerine Proteases

Study Officials

  • Kaichun Wu, Ph.D. & M.D.

    Xijing Hospital of Digestive DIsease

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

CN(1)