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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
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The purpose of this study is to evaluate the efficacy and safety of the new technique of HybridAPC in the treatment of Barrett.
After thermal ablation of Barrett's esophagus, stricture formation is reported in 5 to over 10% of patients. Submucosal fluid injection prior to ablation may lower the risk of stricture formation. The new technique of HybridAPC which combines submucosal injection with APC is considered to reduce the complication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HybridAPC | Experimental | The patient with Barrett's esophagus is treatment by HybridAPC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HybridAPC | Device | HybridAPC is a device which combines submucosal fluid injection with APC |
|
| Measure | Description | Time Frame |
|---|---|---|
| radical rate | Radical rate was defined as it that after 3 months of treatment, the primary lesion area returning to normal is reconfirmed by pathological diagnosis. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence | Recurrence was defined as it that after 3 months of treatment, Barrett's esophagus is reconfirmed by pathological diagnosis in the primary lesion again. | 3 months |
| adverse event | Adverse event was defined as any device treatment-related adverse event such as bleeding and perforation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wang, M.D | Contact | 8613816758802 | dongwang0901@sina.com | |
| Zhijie Wang, M.D | Contact | 8613816758802 | wangzhijie0708@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, M.D | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Changhai Hospital, Second Military Medical University | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24165758 | Result | 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. | |
| 26104794 |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
| Taizhou Hospital | OTHER |
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| 1 year |
| operation time | Operation time was defined as the time from the beginning of submucosal injection to the final end of ablation. | 1 day |
| Result |
| 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. |
| 25360316 | Result | 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. |
| 20485617 | Result | 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. |
| 17057569 | Result | 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. |
| D004066 |
| Digestive System Diseases |