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Status unknownNCT03418584Updated Feb 1, 2018

Application of hybridAPC in the Treatment of Barrett

An interventional study of HybridAPC in Barrett's Esophagus, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Barrett's Esophagus

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Keywords

  • argon plasma coagulation
  • submucosal injection
  • Barrett Esophagus
03

In context

Barrett Esophagus

316 studies on the registry are indexed under Barrett Esophagus; 62 are open to participants now.

This study's planned enrollment of 80 is above the median of 61 across 190 interventional studies indexed under Barrett Esophagus.

Browse Barrett Esophagus studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.

Browse Changhai Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    HybridAPC

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

    Device: HybridAPC

Interventions

  • DeviceHybridAPC

    HybridAPC is a device which combines submucosal fluid injection with APC

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What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. adverse event

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

    Time frame: 1 year

  3. operation time

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

    Time frame: 1 day

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Study locations

1 of 1 sites recruiting
  • Department of Gastroenterology, Changhai Hospital, Second Military Medical University
    Shanghai, Shanghai Municipality 200433, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24165758 ↗
  • 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. PubMed 26104794 ↗
  • 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. PubMed 25360316 ↗
  • 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. PubMed 20485617 ↗
  • 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. PubMed 17057569 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03418584
Lead 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
Responsible party
Zhaoshen Li (Director of Gastroenterology Dept, Changhai Hospital) — Principal investigator
First posted
Feb 1, 2018
Start date
Dec 5, 2017
Primary completion
Dec 5, 2020 (estimated)
Completion
Dec 5, 2021 (estimated)
Last update
Feb 1, 2018

Study contacts

Dong Wang, M.D
Contact
dongwang0901@sina.com
8613816758802
Zhijie Wang, M.D
Contact
wangzhijie0708@163.com
8613816758802
Zhaoshen Li, M.D
principal investigator · Changhai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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