NCT02725398|UnknownDMC
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Sponsor study identifier
interventional
150
1 country
1
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Gastrointestinal cancer has developed into a serious health problem in China. 80%-90% patients were detected at middle and later stage. The five-year survival rate for advanced cancer patients is less than 10%. The main reason of the bad clinical diagnosis and treatment is that the present technical method is difficult to achieve early diagnosis. Endoscopy with biopsy is still the main method for confirming gastrointestinal cancer. But it is limited to identify early tumors and it leads to the low diagnostic rate of early tumors and the poor overall therapeutic effect. Confocal laser endoscopy (CLE) can obtain pathologic information of lesion in real time and improve the diagnostic rate of early tumors. Probe-based confocal laser endomicroscopy(pCLE) is a new technology recently. Since its laser probe is applicable to all conventional endoscopes, pCLE greatly increased its clinical application. However, gastrointestinal motility has greatly influence on pCLE imaging quality and inspection effect owing to the poor stability of the small probe manipulation. Scopolamine (654-2, in China) is clinically used to inhibit bowel peristalsis, but its effect is still not ideal and its side effects are common.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
March 21, 2016
Actual (reported)April 1, 2016
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
high quality image ratio
up to 3 years
spasm score
3 years
diagnosis accuracy rate
3 years
scale value of patient' comfort degree assessed by using visual analogue scale (VAS)
3 years
First to use standard white light to observe, to record spasm score, to observe the lesion.Buscopan (BSP, 20mg) is administered by endoscopic nurse, recorded blindly.
First to use standard white light to observe, to record spasm score, to observe the lesion.Scopolamine is administered by endoscopic nurse, recorded blindly.
First to use standard white light to observe, to record spasm score, to observe the lesion. Physiological saline is administered by endoscopic nurse, recorded blindly.
Buscopan is administered by endoscopic nurse in the Buscopan group,and then recording the outcome measures.
Scopolamine is administered by endoscopic nurse in the Scopolamine group,and then recording the outcome measures.
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032, China
Kaichun Wu, M.D., Prof.
Xijing Hospital of Digestive Diseases
First Submitted
March 21, 2016
First Posted
April 1, 2016
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
Physiological saline is administered by endoscopic nurse in the physiological saline group,and then recording the outcome measures.
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December 2016
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 1, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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