Radiofrequency Ablation vs Sham Procedure for Symptomatic Cervical Inlet Patch

NCT03471052 | Unknown

• 1 other identifier: 216038
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (4)

• Reduction in globus symptoms

  \>50% reduction in globus as assessed by improvement in patient symptom scoring

  6 months post ablation

• Endoscopic eradication of inlet patch

  Eradication of inlet patch as assessed by endoscopic investigation

  Change from 6 months to 12 months post final ablation

• Histological reversal to squamous mucosa

  Complete histological reversal to squamous mucosa as assessed by histological staining of the biopsy samples

  Change at 6 and 12 months

• Change in surface area of residual inlet patch post ablation

  Change in surface area of residual inlet patch post ablation

  Change at 6 and 12 months

Secondary Outcomes (4)

• Oesophageal pH pre and post ablation

  Change at Pre-screening and 12 months

• Adverse events

  Through study completion, an average of 12 months

• Presence of buried mucosa consistent with inlet patch

  During endoscopy

• Symptomatic response for cough, hoarseness and sore throat using Visual Analogue Scale (VAS)

  Through study completion, an average of 12 months

Study Arms (2)

Radiofrequency ablation (RFA)

EXPERIMENTAL

Radiofrequency ablation (RFA)

Procedure: Radiofrequency ablation (RFA)

Sham procedure

NO INTERVENTION

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.

Interventions

Radiofrequency ablation (RFA) PROCEDURE

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.

Radiofrequency ablation (RFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptoms secondary to Inlet patch and globus score \> 50 on Visual Analogue Scale (VAS)
• Histological confirmation of presence of Inlet patch
• Symptoms not responsive or partially responsive to (proton pump inhibitor) PPI therapy for \> = 6 weeks
• 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.
• Patients must sign an informed consent form.

You may not qualify if:

• Patients in whom endoscopy is contraindicated.
• No globus symptoms
• Patients previously or currently treated for oesophageal dysplasia or cancer
• Patients with eosinophilic oesophagitis
• Patients with oesophageal varices
• Previous radiotherapy
• Patients who have undergone Hellers myotomy
• Pregnant females.
• People under the age of 18 years.
• Evidence of major motility disorder on High resolution Manometry
• Patients with pre-existing ENT disorders causing globus.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jason Dunn

  Consultant Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Dunn

CONTACT

02071887188; GMSresearch@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 20, 2018
• Study Start: March 6, 2018
• Primary Completion: January 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)