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RANDOMISED CONTROLLED TRIAL OF BARRXTM RADIOFREQUENCY ABLATION THROUGH-THE-SCOPE DEVICE VERSUS SHAM FOR SYMPTOMATIC CERVICAL (GASTRIC) INLET PATCH - INTERIM ANALYSIS
Date
May 21, 2024
Introduction
A cervical (gastric) inlet patch is a common congenital anomaly of the upper oesophagus affecting 5% of the population. It can be associated with symptoms which can impact quality of life, including globus. Proton pump inhibitors (PPI) are often ineffective. We have previously demonstrated safety of BarrxTM radiofrequency ablation (RFA) in a pilot study (1).
We aimed to assess the efficacy of BarrxTM RFA through the scope (TTS) device for treatment of a cervical inlet patch in symptomatic patients in a randomised sham-controlled trial. We present the interim analysis.
Methods
This was a multicentre double blinded sham-controlled trial. There was a single arm crossover for the sham group to RFA at 6 months following 1:1 randomization. Target recruitment is 50 patients with globus greater than 50/100 on visual analogue scales (VAS) and no response to PPI’s.
All patients had histologically confirmed inlet patch, 24-hour pH studies and high-resolution manometry, biopsies to rule out eosinophilic oesophagitis and ENT review with flexible naso-endoscopy.
There was a maximum of 2 RFA treatments (12 joules, triple hit, no clean technique) in the treatment/cross over arm.
Questionnaires and VAS scores (0 -100) were used to assess symptomatic response in both treatment and sham arms at 6 weeks, 3 months and 1-year post treatment or sham.
Results
26 patients with a symptomatic cervical inlet patch have been recruited to date. The median age was 59 years (IQR, 52 – 68).
14 patients were randomised to the treatment group and 12 patients to the Sham group. 9 patients from the Sham group crossed over to the treatment group after an initial 6 month follow up. The median inlet patch size at baseline was 15mm with no significant difference between treatment and sham groups. All patients underwent procedures under midazolam and fentanyl.
There was a significant reduction in globus VAS scores in the treatment group versus sham (82 (IQR, 65-97) to 32 (IQR, 12-74), P < 0.05 vs 78 (IQR, 61 – 97) to 77 (IQR, 31 -92) (Figure 1).
The baseline Median globus VAS score pre-treatment in all the placebo patients was 78 (IQR, 61–97). The median globus VAS score post RFA in all patients (treatment and cross over group) was 31 (IQR, 11-65).
There was a significant reduction in the median inlet patch size following 2 RFA treatments in treatment and cross over arms from 15mm (IQR, 8-38) to 2mm (IQR, 0-5) (P< 0.0001). (Figure 2)
There were no strictures following treatment with RFA.
Conclusion
Initial results show the RFA TTS device is effective for the treatment of a cervical inlet patch with significant symptomatic improvement for patient’s versus a sham procedure. There were no post treatment strictures.
1. J Dunn et al. Radiofrequency ablation of symptomatic cervical inlet patch using a through-the-scope device: a pilot study. Gastrointest Endosc 2016;84(6):1022- 1026
A cervical (gastric) inlet patch is a common congenital anomaly of the upper oesophagus affecting 5% of the population. It can be associated with symptoms which can impact quality of life, including globus. Proton pump inhibitors (PPI) are often ineffective. We have previously demonstrated safety of BarrxTM radiofrequency ablation (RFA) in a pilot study (1).
We aimed to assess the efficacy of BarrxTM RFA through the scope (TTS) device for treatment of a cervical inlet patch in symptomatic patients in a randomised sham-controlled trial. We present the interim analysis.
Methods
This was a multicentre double blinded sham-controlled trial. There was a single arm crossover for the sham group to RFA at 6 months following 1:1 randomization. Target recruitment is 50 patients with globus greater than 50/100 on visual analogue scales (VAS) and no response to PPI’s.
All patients had histologically confirmed inlet patch, 24-hour pH studies and high-resolution manometry, biopsies to rule out eosinophilic oesophagitis and ENT review with flexible naso-endoscopy.
There was a maximum of 2 RFA treatments (12 joules, triple hit, no clean technique) in the treatment/cross over arm.
Questionnaires and VAS scores (0 -100) were used to assess symptomatic response in both treatment and sham arms at 6 weeks, 3 months and 1-year post treatment or sham.
Results
26 patients with a symptomatic cervical inlet patch have been recruited to date. The median age was 59 years (IQR, 52 – 68).
14 patients were randomised to the treatment group and 12 patients to the Sham group. 9 patients from the Sham group crossed over to the treatment group after an initial 6 month follow up. The median inlet patch size at baseline was 15mm with no significant difference between treatment and sham groups. All patients underwent procedures under midazolam and fentanyl.
There was a significant reduction in globus VAS scores in the treatment group versus sham (82 (IQR, 65-97) to 32 (IQR, 12-74), P < 0.05 vs 78 (IQR, 61 – 97) to 77 (IQR, 31 -92) (Figure 1).
The baseline Median globus VAS score pre-treatment in all the placebo patients was 78 (IQR, 61–97). The median globus VAS score post RFA in all patients (treatment and cross over group) was 31 (IQR, 11-65).
There was a significant reduction in the median inlet patch size following 2 RFA treatments in treatment and cross over arms from 15mm (IQR, 8-38) to 2mm (IQR, 0-5) (P< 0.0001). (Figure 2)
There were no strictures following treatment with RFA.
Conclusion
Initial results show the RFA TTS device is effective for the treatment of a cervical inlet patch with significant symptomatic improvement for patient’s versus a sham procedure. There were no post treatment strictures.
1. J Dunn et al. Radiofrequency ablation of symptomatic cervical inlet patch using a through-the-scope device: a pilot study. Gastrointest Endosc 2016;84(6):1022- 1026
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