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Radiofrequency Ablation vs Sham Procedure for Symptomatic Cervical Inlet Patch

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ClinicalTrials.gov Identifier: NCT03471052
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

Inlet patch is a congenital condition of the upper oesophagus, consisting of stomach lining that is in the wrong place. It affects 5% of the population. Symptoms are a feeling of a ball in the back of the throat (called chronic globus sensation), cough and sore throat - these account for 4% of general practitioner (GP) referral to Ear Nose & Throat departments.

There is no recognised treatment. Drugs that reduce acid may help but do not block mucus production. Argon Plasma coagulation has been shown to be successful but limited to a few expert centres. The investigators have previously shown a device that uses radiofrequency energy to remove the patch to be highly effective in a ten patient pilot study, with 80% response rate that was durable over 1 year.

The purpose of this trial is to demonstrate the previous study was not due to placebo effect alone, with a sham controlled arm. Patients would then crossover to treatment at 6 months after sham. All males and non-pregnant females over 18 years old with previously diagnosed inlet patch causing symptoms of globus, with > 50% severity on a visual analogue score, are eligible.


Condition or disease Intervention/treatment Phase
Barrett Esophagus Procedure: Radiofrequency ablation (RFA) Not Applicable

Detailed Description:

Inlet patch is a congenital anomaly of the upper oesophagus, consisting of stomach lining that is in an aberrant position. Prevalence is up to 10% on endoscopy studies and 5% on post mortem studies. There is thought to be a link with another condition of the lower oesophagus called Barrett's oesophagus, although there is limited evidence. Unlike Barrett's oesophagus, progression to cancer from an inlet patch is exceptionally rare.

The inlet patch can produce acid and mucus, and is associated with symptoms including sore throat, cough and hoarseness. One particular symptom, called globus pharyngeus (the feeling of a ball in the back of the throat) is often associated with an inlet patch.

There is no recognised treatment for symptomatic inlet patch. Anti-acid medications works for some but not all, which may in part be explained by the lack of acid producing cells in some inlet patches. Ablation of the inlet patch has been successful in small series using Argon Plasma Coagulation. This device is, however, associated with inter user variability and unpredictable depth of ablation. Radiofrequency ablation (RFA) using the BarrxTM System is a National Institute for Health and Clinical Excellence (NICE) and FDA approved device for treatment of abnormal oesophageal lining, which has shown to be successful in reversing Barrett's oesophagus to normal squamous lining. These devices are advantageous as the depth of ablation is controlled. The investigators have previously demonstrated, in a pilot study, that these devices are safe and effective for reversal of inlet patch to normal mucosa, with improvement in symptoms.

This study will use the BarrxTM system to treat patients with symptomatic inlet patch that is refractory to standard anti-acid medication, in a blinded sham controlled trial.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Radiofrequency Ablation Versus a Sham Procedure for Symptomatic Cervical Inlet Patch
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: Radiofrequency ablation (RFA)
Radiofrequency ablation (RFA)
Procedure: Radiofrequency ablation (RFA)

Ablation using the Barrx RFA System is a new technique for field ablation in the oesophagus. It has been used for eradication of diseased epithelium of all three subclasses of Barrett's oesophagus (non-dysplastic Intestinal metaplasia (IM), Low grade dysplasia (LGD) and High grade dysplasia (HGD). The BarrxTM RFA System uses ultra short pulse RF energy delivering 40Watts/cm2 power density and 12Joule/cm2 energy density, and affects the mucosa whilst preserving the submucosa.

Clinical trials have suggested that it is safe and effective for treating non-dysplastic IM, LGD and HGD in Barrett's oesophagus . Long term data show the effect to be durable over 5 years.


No Intervention: Sham procedure
Endoscopy will be performed under conscious sedation and all BarrX RFA equipment will be set up in room. A sound recording of the BarrxTM RFA device will be played (a distinct bell sound that is emitted from the generator) during the procedure.



Primary Outcome Measures :
  1. Reduction in Globus symptoms [ Time Frame: 6 months post ablation ]
    >50% reduction in globus as assessed by improvement in patient symptom scoring


Secondary Outcome Measures :
  1. Endoscopic inlet patch eradication [ Time Frame: 6 and 12 months ]
    Eradication of inlet patch as assessed by endoscopic investigation

  2. Histological reversal to squamous mucosa [ Time Frame: 6 and 12 months ]
    Complete histological reversal to squamous mucosa as assessed by histological staining of the biopsy samples



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with symptoms secondary to Inlet patch and globus score > 50 on Visual Analogue Scale (VAS)
  2. Histological confirmation of presence of Inlet patch
  3. Symptoms not responsive or partially responsive to (proton pump inhibitor) PPI therapy for > = 6 weeks
  4. Males and non-pregnant females over the age of 18 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception.
  5. Patients must sign an informed consent form.

Exclusion Criteria:

  1. Patients in whom endoscopy is contraindicated.
  2. No globus symptoms
  3. Patients previously or currently treated for oesophageal dysplasia or cancer
  4. Patients with eosinophilic oesophagitis
  5. Patients with oesophageal varices
  6. Previous radiotherapy
  7. Patients who have undergone Hellers myotomy
  8. Pregnant females.
  9. People under the age of 18 years.
  10. Evidence of major motility disorder on High resolution Manometry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471052


Contacts
Contact: Amy Day 07393242712 amy.day@gstt.nhs.uk
Contact: Jessica Cordle 02071887188 ext 88564 Jessica.Cordle@gstt.nhs.uk

Locations
United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Dr Day    07393242712    Amy.Day@gstt.nhs.uk   
Contact: Dr Dunn    02071887188 ext 82492    Jason.Dunn@gstt.nhs.uk   
Principal Investigator: Dr J Dunn         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Jason Dunn Consultant Gastroenterology

Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03471052     History of Changes
Other Study ID Numbers: 216038
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases