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OpenTrials
Completed

NCT Number: NCT02030769

Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

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.

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Key information

Conditions

Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pronase

Drug

use pronase to improve visibility during endoscopical iodine staining

Control

Drug

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

Primary outcomes

  1. Detection rate of high grade dysplasia and carcinoma in iodine void lesion

    Time frame: 1 week

    Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）*100%

Secondary outcomes

  1. Average Esophageal Visibility Score Before iodine staining

    Time frame: 30 min after ingesting pretreatment solution

  2. Average Esophageal Visibility Score After iodine staining

    Time frame: within 5 min after iodine staining

  3. Detection Rate of lesions with pink sign

    Time frame: within 5 min after iodine staining

  4. overall detection rate of iodine void lesion

    Time frame: within 5 min after iodine staining

Other outcomes

  1. observation time for esophagus

    Time frame: with 30 min after intubation

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Collaborators

  • Beijing Tide Pharmaceutical Co., Ltd

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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