Application of hybridAPC in the Treatment of Barrett

Barrett's Esophagus Clinical Trial

Official title:

Application of hybridAPC in the Treatment of Barrett: a Multicenter, Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03418584
• Other study ID #: XHD2017
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2018
• Last updated: January 25, 2018
• Start date: December 5, 2017
• Est. completion date: December 5, 2021

Study information

• Verified date: January 2018
• Source: Changhai Hospital
• Contact: Dong Wang, M.D
• Phone: 8613816758802
• Email: dongwang0901[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of the new technique of HybridAPC in the treatment of Barrett.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• HybridAPC
HybridAPC is a device which combines submucosal fluid injection with APC

Locations

Country	Name	City	State
China	Department of Gastroenterology, Changhai Hospital, Second Military Medical University	Shanghai	Shanghai

Sponsors (7)

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

Country where clinical trial is conducted

China, 

References & Publications (5)

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

Outcome

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