Application of hybridAPC in the Treatment of Barrett

NCT ID: NCT03418584

Last Updated: 2018-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2021-12-05

Brief Summary

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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

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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.

Conditions

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Barrett's Esophagus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HybridAPC

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

Group Type EXPERIMENTAL

HybridAPC

Intervention Type DEVICE

HybridAPC is a device which combines submucosal fluid injection with APC

Interventions

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HybridAPC

HybridAPC is a device which combines submucosal fluid injection with APC

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Li, M.D

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Wang, M.D

Role: CONTACT

8613816758802

Zhijie Wang, M.D

Role: CONTACT

8613816758802

Facility Contacts

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Dong Wang, MD

Role: primary

008613816758802

References

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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.

Reference Type RESULT
PMID: 24165758 (View on PubMed)

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.

Reference Type RESULT
PMID: 26104794 (View on PubMed)

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.

Reference Type RESULT
PMID: 25360316 (View on PubMed)

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.

Reference Type RESULT
PMID: 20485617 (View on PubMed)

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.

Reference Type RESULT
PMID: 17057569 (View on PubMed)

Other Identifiers

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XHD2017

Identifier Type: -

Identifier Source: org_study_id

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