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NCT02725398
Effect of Buscopan on Gastrointestinal Imaging Quality With Probe-based Confocal Laser Endomicroscopy
NA trial testing Buscopan in Gastrointestinal Imaging With pCLE in 150 participants. Status unknown.
1 December 2016
Quick facts
| Lead sponsor | Xijing Hospital of Digestive Diseases |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 150 |
| Start date | 1 December 2013 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 1 location across China |
Drugs / interventions tested
- Buscopan (scopolamine butylbromide) — full drug profile →
- Scopolamine — full drug profile →
- physiological saline — full drug profile →
Conditions studied
- Gastrointestinal Imaging With pCLE — all drugs for Gastrointestinal Imaging With pCLE →
Sponsor
Xijing Hospital of Digestive Diseases
Who can join
Adults 18 to 80, any sex, with Gastrointestinal Imaging With pCLE. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
high quality image ratio
Time frame: up to 3 years
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02725398
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02725398 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital of Digestive Diseases
- Last refreshed: 31 March 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02725398.
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