Barrett's EsophagusNCT03418584
Application of hybridAPC in the Treatment of Barrett
A study testing HybridAPC in people with Barrett's Esophagus, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- HybridAPC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2017to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age is from 18 to 70.
- Patients who were diagnosed with Barrett's esophagus.
- Informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200433
Dong Wang, MD, 008613816758802, dongwang0901@sina.com
About this study
Official title: Application of hybridAPC in the Treatment of Barrett: a Multicenter, Prospective Study
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.
- Conditions
- Barrett's Esophagus
- Being tested
- HybridAPC
- Keywords
- argon plasma coagulation, submucosal injection, Barrett Esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HybridAPCDevice
HybridAPC is a device which combines submucosal fluid injection with APC
| Study group | Role | What they receive |
|---|---|---|
| HybridAPC | Experimental | The patient with Barrett's esophagus is treatment by HybridAPC. Receives: Device: HybridAPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
adverse event
Adverse event was defined as any device treatment-related adverse event such as bleeding and perforation
Measured: 1 year
operation time
Operation time was defined as the time from the beginning of submucosal injection to the final end of ablation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start5 Dec 2017
- Primary completion5 Dec 2020 (estimated)
- Study completion5 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418584
- Sponsor's protocol ID
- XHD2017
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2018
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24165758Manner 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 26104794Manner 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 25360316Fujishiro 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 20485617Fujishiro 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of hybridAPC in the Treatment of Barrett: a Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT03418584
- Acronym / sponsor ID
- XHD2017
- Conditions
- Barrett's Esophagus
- Keywords
- argon plasma coagulation, submucosal injection, Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- 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
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 5 Dec 2020 (estimated)
- Study completion
- 5 Dec 2021 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HybridAPC | Experimental | Device: HybridAPCThe patient with Barrett's esophagus is treatment by HybridAPC. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age is from 18 to 70.
- Patients who were diagnosed with Barrett's esophagus.
- Informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HybridAPCHybridAPC is a device which combines submucosal fluid injection with APC | Device | HybridAPC |
Primary outcome
radical rate
Time frame: 3 months
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 secondary outcomes
recurrence
Time frame: 3 months
adverse event
Time frame: 1 year
operation time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Results publication: PubMed 24165758Fitzgerald 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 publication: PubMed 26104794Manner 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.
- Results publication: PubMed 25360316Manner 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 publication: PubMed 20485617Fujishiro 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 publication: PubMed 17057569Fujishiro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoshen Li, M.D principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HybridAPC in people with Barrett's Esophagus, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Wang, M.D (8613816758802, dongwang0901@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radical rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418584, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.