Barrett's Esophagus
Conditions
Keywords
argon plasma coagulation, submucosal injection, Barrett Esophagus
Brief summary
The purpose of this study is to evaluate the efficacy and safety of the new technique of HybridAPC in the treatment of Barrett.
Detailed description
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.
Interventions
DEVICEHybridAPC
HybridAPC is a device which combines submucosal fluid injection with APC
Sponsors
Shanghai Zhongshan Hospital
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Soochow University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Shanghai Tongji Hospital, Tongji University School of Medicine
Taizhou Hospital
Changhai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radical rate | 3 months | Radical rate was defined as it that after 3 months of treatment, the primary lesion area returning to normal is reconfirmed by pathological diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence | 3 months | Recurrence was defined as it that after 3 months of treatment, Barrett's esophagus is reconfirmed by pathological diagnosis in the primary lesion again. |
| adverse event | 1 year | Adverse event was defined as any device treatment-related adverse event such as bleeding and perforation |
| operation time | 1 day | Operation time was defined as the time from the beginning of submucosal injection to the final end of ablation. |
Countries
China
Contacts
Primary ContactDong Wang, M.D
Backup ContactZhijie Wang, M.D
Outcome results
None listed