NCT03418584

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

January 10, 2018

Last Update Submit

January 25, 2018

Conditions

Barrett's Esophagus

Keywords

argon plasma coagulationsubmucosal injectionBarrett Esophagus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • recurrence

    3 months

  • adverse event

    1 year

  • operation time

    1 day

Study Arms (1)

HybridAPC

EXPERIMENTAL

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

Device: HybridAPC

Interventions

HybridAPCDEVICE

HybridAPC is a device which combines submucosal fluid injection with APC

HybridAPC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related 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; 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.

    PMID: 24165758RESULT

  • 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.

    PMID: 26104794RESULT

  • 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.

    PMID: 25360316RESULT

  • 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.

    PMID: 20485617RESULT

  • 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.

    PMID: 17057569RESULT

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Zhaoshen Li, M.D

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wang, M.D

CONTACT

8613816758802dongwang0901@sina.com

Zhijie Wang, M.D

CONTACT

8613816758802wangzhijie0708@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept

Study Record Dates

First Submitted

January 10, 2018

First Posted

February 1, 2018

Study Start

December 5, 2017

Primary Completion

December 5, 2020

Study Completion

December 5, 2021

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)