Application of hybridAPC in the Treatment of Barrett

Not Applicable

• Conditions: Barrett's Esophagus
• Interventions: Device: HybridAPC

• Registration Number: NCT03418584
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2017-12-05
• Status Verified: 2018-01
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Study First Posted: 2018-02-01
• Last Update Posted: 2018-02-01
• Primary Completion: 2020-12-05
• Study Completion: 2021-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HybridAPC	HybridAPC	The patient with Barrett's esophagus is treatment by HybridAPC.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Department of Gastroenterology, Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China