Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-12-05
2021-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HybridAPC
The patient with Barrett's esophagus is treatment by HybridAPC.
HybridAPC
HybridAPC is a device which combines submucosal fluid injection with APC
Interventions
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HybridAPC
HybridAPC is a device which combines submucosal fluid injection with APC
Eligibility Criteria
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Inclusion Criteria
2. Patients who were diagnosed with Barrett's esophagus.
3. Informed consent.
Exclusion Criteria
2. Severe bleeding tendency.
3. Poor compliance.
4. Patient is very ill and life expectancy is less than 2 years.
5. Esophageal varices or venous aneurysms, and no effective prevention or treatment for bleeding.
6. Severe esophageal stenosis.
7. Pregnancy.
8. Lesion is located in esophageal diverticulum or spread their diverticulum.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Shanghai Tongji Hospital, Tongji University School of Medicine
OTHER
Taizhou Hospital
OTHER
Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
Director of Gastroenterology Dept
Principal Investigators
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Zhaoshen Li, M.D
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Department of Gastroenterology, Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Fitzgerald RC, di Pietro M, Ragunath K, Ang Y, Kang JY, Watson P, Trudgill N, Patel P, Kaye PV, Sanders S, O'Donovan M, Bird-Lieberman E, Bhandari P, Jankowski JA, Attwood S, Parsons SL, Loft D, Lagergren J, Moayyedi P, Lyratzopoulos G, de Caestecker J; British Society of Gastroenterology. British Society of Gastroenterology guidelines on the diagnosis and management of Barrett's oesophagus. Gut. 2014 Jan;63(1):7-42. doi: 10.1136/gutjnl-2013-305372. Epub 2013 Oct 28.
Manner H, May A, Kouti I, Pech O, Vieth M, Ell C. Efficacy and safety of Hybrid-APC for the ablation of Barrett's esophagus. Surg Endosc. 2016 Apr;30(4):1364-70. doi: 10.1007/s00464-015-4336-1. Epub 2015 Jun 24.
Manner H, Neugebauer A, Scharpf M, Braun K, May A, Ell C, Fend F, Enderle MD. The tissue effect of argon-plasma coagulation with prior submucosal injection (Hybrid-APC) versus standard APC: A randomized ex-vivo study. United European Gastroenterol J. 2014 Oct;2(5):383-90. doi: 10.1177/2050640614544315.
Fujishiro M, Kodashima S, Ono S, Goto O, Yamamichi N, Yahagi N, Kashimura K, Matsuura T, Iguchi M, Oka M, Ichinose M, Omata M. Submucosal Injection of Normal Saline can Prevent Unexpected Deep Thermal Injury of Argon Plasma Coagulation in the in vivo Porcine Stomach. Gut Liver. 2008 Sep;2(2):95-8. doi: 10.5009/gnl.2008.2.2.95. Epub 2008 Sep 30.
Fujishiro M, Yahagi N, Nakamura M, Kakushima N, Kodashima S, Ono S, Kobayashi K, Hashimoto T, Yamamichi N, Tateishi A, Shimizu Y, Oka M, Ichinose M, Omata M. Submucosal injection of normal saline may prevent tissue damage from argon plasma coagulation: an experimental study using resected porcine esophagus, stomach, and colon. Surg Laparosc Endosc Percutan Tech. 2006 Oct;16(5):307-11. doi: 10.1097/01.sle.0000213739.85277.3d.
Other Identifiers
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XHD2017
Identifier Type: -
Identifier Source: org_study_id
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