Barrett's Esophagus Clinical Trial
Official title:
Application of hybridAPC in the Treatment of Barrett: a Multicenter, Prospective Study
The purpose of this study is to evaluate the efficacy and safety of the new technique of HybridAPC in the treatment of Barrett.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 5, 2021 |
Est. primary completion date | December 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Patients age is from 18 to 70. 2. Patients who were diagnosed with Barrett's esophagus. 3. Informed consent. Exclusion Criteria: 1. Patient with severe cardiopulmonary dysfunction is unable to tolerated by endoscopy. 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Gastroenterology, Changhai Hospital, Second Military Medical University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital | First Affiliated Hospital of Zhejiang University, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai Zhongshan Hospital, Taizhou Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Soochow University |
China,
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; B — View Citation
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 Porc — View Citation
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 — View Citation
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. Erratum in: Surg Endosc. 2016 Apr;30(4):137 — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | adverse event | Adverse event was defined as any device treatment-related adverse event such as bleeding and perforation | 1 year | |
Secondary | operation time | Operation time was defined as the time from the beginning of submucosal injection to the final end of ablation. | 1 day |
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