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EFFICACY AND SAFETY OF CRYOBALLOON180 ABLATION FOR THE TREATMENT OF DYSPLASTIC BARRETT ESOPHAGUS: PRELIMINARY RESULTS FROM A PROSPECTIVE MULTICENTER STUDY

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EFFICACY AND SAFETY OF CRYOBALLOON180 ABLATION FOR THE TREATMENT OF DYSPLASTIC BARRETT ESOPHAGUS: PRELIMINARY RESULTS FROM A PROSPECTIVE MULTICENTER STUDY

Koen Munters 1, Charlotte N. Frederiks 2, Anouk Overwater 2, Roos E. Pouw 3, Jacques J. Bergman 4, Sanne van Munster 5, Bas L.A.M. Weusten 2

Affiliations

1 St. Antonius Hospital, Nieuwegein, Netherlands|||UMC Utrecht, Utrecht, Netherlands

2 UMC Utrecht, Utrecht, Netherlands|||St. Antonius Hospital, Nieuwegein, Netherlands

3 Amsterdam UMC, Amsterdam, Netherlands

4 Academic Medical Centre, Amsterdam, Netherlands

5 St. Antonius Hospital, Nieuwegein, Netherlands|||Academic Medical Centre, Amsterdam, Netherlands

Summary

AI Generated

Circumferential cryoballoon ablation with the CBAS¹⁸⁰ system at 1.2 mm/sec followed by focal cryoballoon ablation achieved 90% median Barrett's esophagus regression and complete eradication of dysplasia in all patients completing treatment, with an 8% adverse event rate.

In 23 successfully treated patients with ablation-naïve dysplastic Barrett's esophagus (median length C0M2), CBAS¹⁸⁰ achieved median 90% BE regression at 3 months as assessed by independent adjudication committee.
Technical success rate was 92% (23/25 patients); two patients could not be treated due to unstable balloon positioning or device malfunction.
CBAS¹⁸⁰ adverse event rate was 8% (2/23): one esophageal stricture (4%) resolved after single dilation and one post-procedural bleeding (4%) requiring re-endoscopy without intervention.
Follow-up treatment with focal cryoballoon ablation achieved complete eradication of visible BE in 18 patients after median 1 additional treatment, with 100% complete eradication of dysplasia and intestinal metaplasia in this group.
The procedure was well tolerated with low post-procedural pain (median score 2 at day 1, 0 at day 7) and dysphagia (44% at day 1, 30% at day 7 with score ≥1).
The presenter concluded that CBAS¹⁸⁰ is effective and safe in expert hands and recommended further research in longer Barrett's segments and stacked ablations.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Cryoballoon ablation is a relatively novel method which can be used for the eradication of dysplastic Barrett esophagus (BE). While the focal cryoballoon ablation system has shown to be efficacious for BE of limited extent, the cryoballoon¹⁸⁰ ablation system (CBAS¹⁸⁰) is developed to treat longer BE segments by semi-circumferential ablation over 3cm in a single step. A prior first-in-human study demonstrated the feasibility of CBAS¹⁸⁰ treatment¹, yet the optimal dose needs to be determined. Therefore, in the current prospective multicenter study, we investigate CBAS¹⁸⁰ at lower dosages for patients with dysplastic BE. In addition, we report on the results of CBAS¹⁸⁰ followed by focal cryoballon ablation (fCBA).

Aims & Methods

A total of 50 patients with ablation naïve BE (C≤3 and M≥1) will be enrolled in six Dutch Barrett expert centers. Treatment consists of a full circumferential ablation over 3 cm of length, using two semi-circumferential ablations at a dose of 1.2 mm/sec. Follow-up consisted of follow-up phone calls at days 1, 7 and 30, a symptom diary during 14 days, and a follow-up endoscopy after 3 months. Outcomes included:
(1) technical success rate,
(2) BE regression percentage at follow-up scored by an independent adjudication committee and the treating endoscopist,
(3) incidence of adverse events,
(4) post-procedural pain (on a scale of 0-10), and
(5) post-procedural dysphagia (on a scale of 0-4).
Follow-up treatment consisted of fCBA treatments until complete eradication of visible BE was achieved, confirmed by biopsies from the neo-Z-line.

Results

So far, 25 patients (80% male; mean age 67) with a median BE length of C0M2 (p25-p75 C0-1M2-4) were included. Technical success rate was 92% (23/25). In two patients, treatment was technically unsuccessful due to unstable positioning of the balloon (n=1) or a device malfunction (n=1). Median procedure time was 14 (p25-p75 11-16) 4) minutes and median ablation time was 5 (p25-p75 3-5) minutes. All 23 successfully treated patients completed follow-up endoscopy at 3 months. Median BE regression was 90% (p25-p75 75%-100%) and 95% (p25-p75 75%-99%) as evaluated by the independent adjudication committee and the treating endoscopist, respectively. Overall, CBAS¹⁸⁰ adverse event rate was 8% (2/23), with one patient developing a esophageal stricture (1/23; 4%) resolved after a single endoscopic dilation. Another patient (1/23; 4%) experienced post-procedural bleeding, resulting in re-endoscopy without intervention. The CBAS¹⁸⁰ procedure was well tolerated with low post-procedural pain (median 2 [p25-p75 1-4] at day 1 and 0 [p25-p75 0-1] at day 7) and dysphagia (44% and 30% of patients with score ≥1 at day 1 and 7) scores.
So far, 22/23 patients were treated with fCBA in the follow-up phase, of whom and 4 are still under treatment. The remaining 18 patients achieved complete eradication of all visible BE after median 1 (p25-p75 1-3) fCBA treatments. Based on the histological assessment, a complete eradication of dysplasia and intestinal-metaplasia was achieved in all 18 patients. Two patients developed strictures requiring dilation (2 and 1 dilations, respectively) during the follow-up phase.

Conclusion

Based on these preliminary results, circumferential ablation with CBAS¹⁸⁰ at 1.2 mm/sec, followed by fCBA, emerges as an effective and safe procedure for dysplastic BE eradication in the hands of expert endoscopists. Further avenues for exploration should encompass the assessment of multiple CBAS¹⁸⁰ ablations stacked on top of each other in larger segments and the validation of outcomes in a larger patient cohort.

References

Overwater A, van Munster SN, Nagengast WB, et al. Novel cryoballoon 180° ablation system for treatment of Barrett’s esophagus-related neoplasia: a first-in-human study. Endoscopy. 2022;54(1):64-70. doi:10.1055/a-1381-7562

Disclosure

PENTAX medical consultancy services & spakker's fee

Event

UEG Week Vienna 2024

Topics

Endoscopy Histopathology Oesophagus

Submission format

Abstract

Session

Barrett's oesophagus: Treatment and surveillance

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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COCAINE- AND AMPHETAMINE-REGULATED TRANSCRIPT (CART) PEPTIDE MEDIATES INTRACELLULAR CA2+ RELEASE IN SENSORY NEURONS AND INDUCES FIRING OF THE COLON-INNERVATING LUMBAR SPLANCHNIC NERVE

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