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Application of hybridAPC in the Treatment of Barrett

Primary Purpose

Barrett's Esophagus

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

HybridAPC

About this trial

This is an interventional treatment trial for Barrett's Esophagus focused on measuring argon plasma coagulation, submucosal injection, Barrett Esophagus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients age is from 18 to 70.
Patients who were diagnosed with Barrett's esophagus.
Informed consent.

Exclusion Criteria:

Patient with severe cardiopulmonary dysfunction is unable to tolerated by endoscopy.
Severe bleeding tendency.
Poor compliance.
Patient is very ill and life expectancy is less than 2 years.
Esophageal varices or venous aneurysms, and no effective prevention or treatment for bleeding.
Severe esophageal stenosis.
Pregnancy.
Lesion is located in esophageal diverticulum or spread their diverticulum.

Sites / Locations

Department of Gastroenterology, Changhai Hospital, Second Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HybridAPC

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

adverse event

Adverse event was defined as any device treatment-related adverse event such as bleeding and perforation

operation time

Operation time was defined as the time from the beginning of submucosal injection to the final end of ablation.

Full Information

NCT ID

NCT03418584

First Posted

January 10, 2018

Last Updated

January 25, 2018

Sponsor

Changhai Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03418584

Brief Title

Application of hybridAPC in the Treatment of Barrett

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 5, 2017 (Actual)

Primary Completion Date

December 5, 2020 (Anticipated)

Study Completion Date

December 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Barrett's Esophagus

Keywords

argon plasma coagulation, submucosal injection, Barrett Esophagus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HybridAPC

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

HybridAPC

Intervention Description

HybridAPC is a device which combines submucosal fluid injection with APC

Primary Outcome Measure Information:

Title

radical rate

Description

Radical rate was defined as it that after 3 months of treatment, the primary lesion area returning to normal is reconfirmed by pathological diagnosis.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

recurrence

Description

Recurrence was defined as it that after 3 months of treatment, Barrett's esophagus is reconfirmed by pathological diagnosis in the primary lesion again.

Time Frame

3 months

Title

adverse event

Description

Adverse event was defined as any device treatment-related adverse event such as bleeding and perforation

Time Frame

1 year

Title

operation time

Description

Operation time was defined as the time from the beginning of submucosal injection to the final end of ablation.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients age is from 18 to 70. Patients who were diagnosed with Barrett's esophagus. Informed consent. Exclusion Criteria: Patient with severe cardiopulmonary dysfunction is unable to tolerated by endoscopy. Severe bleeding tendency. Poor compliance. Patient is very ill and life expectancy is less than 2 years. Esophageal varices or venous aneurysms, and no effective prevention or treatment for bleeding. Severe esophageal stenosis. Pregnancy. Lesion is located in esophageal diverticulum or spread their diverticulum.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong Wang, M.D

Phone

8613816758802

dongwang0901@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhijie Wang, M.D

Phone

8613816758802

wangzhijie0708@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoshen Li, M.D

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Gastroenterology, Changhai Hospital, Second Military Medical University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong Wang, MD

Phone

008613816758802

dongwang0901@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24165758

Citation

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.

Results Reference

result

PubMed Identifier

26104794

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):1371.

Results Reference

result

PubMed Identifier

25360316

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 Oct;2(5):383-90. doi: 10.1177/2050640614544315.

Results Reference

result

PubMed Identifier

20485617

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 Porcine Stomach. Gut Liver. 2008 Sep;2(2):95-8. doi: 10.5009/gnl.2008.2.2.95. Epub 2008 Sep 30.

Results Reference

result

PubMed Identifier

17057569

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 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.

Results Reference

result

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Application of hybridAPC in the Treatment of Barrett

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