日本初の吸収性食道用ステント「ELLA-BDステントPX」が 薬事承認を取得しました

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2025-06-03 株式会社パイオラックスメディカルデバイス,国立がん研究センター

国立がん研究センター東病院と株式会社パイオラックスメディカルデバイスが共同開発した吸収性食道用ステント「ELLA-BDステントPX」が、2025年3月7日付で日本初の薬事承認を取得しました。このステントは、生分解性素材ポリジオキサノン製で、難治性食道良性狭窄の患者に留置され、約3ヶ月で体内で分解・吸収されるため、抜去手術が不要です。臨床試験では、嚥下障害スコア(DS)が2以上の患者のうち、3ヶ月後にDSが1以下に改善された割合が先進医療B試験で66.7%、企業治験で46.7%と、有意な改善が確認されました。今後、保険適用に向けた手続きが進められ、患者のQOL向上と医療費負担軽減が期待されています。

日本初の吸収性食道用ステント「ELLA-BDステントPX」が 薬事承認を取得しました

「ELLA-BDステントPX」 (イメージ画像)

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難治性良性食道狭窄患者に対する生分解性ステントの重要試験 Pivotal trial of a biodegradable stent for patients with refractory benign esophageal stricture

Tomonori Yano,Yusuke Yoda,Satoru Nonaka,Seiichiro Abe,Noboru Kawata,Toshiyuki Yoshio,Takashi Sasaki,Shinwa Tanaka,Fumisato Sasaki,Takao Maekita,Masayuki Kitano,Kenshi Matsumoto,Hiroyuki Isayama & Hiroyuki Ono
Esophagus  Published:01 February 2022
DOI:https://doi.org/10.1007/s10388-022-00909-6

Abstract

Objective

Benign esophageal strictures (BES) cause dysphagia and decrease patients’ quality of life. Although mechanical dilation is the standard of care for BES, in some patients, dysphagia is unrelieved despite repeated procedures. The biodegradable stent was developed to resolve refractory BES, with reported favorable outcomes, but it is unapproved in Japan. Thus, we evaluated the safety and efficacy of the biodegradable stent (BDS) for patients with refractory BES for regulatory approval.

Methods

This was a nonrandomized single-arm prospective trial conducted at eight institutions. We included patients with BES after ≥ 5 times of dilation or ≥ one time of radial incision and cutting whose dysphagia score (DS) was 2 or worse and an endoscope could not admit. The primary endpoint was the proportion of patients whose DS improvement of ≤ 1 was maintained at 3 months.

Results

Thirty patients (median age: 69 years, male/female: 27:3) were enrolled and treated; BDS placement failed in 1 patient. Fourteen patients maintained their DS improvement until 3 months after placement (proportion of DS improvement at 3 months 46.7% [95% CI: 28.3–65.7]), and the median dysphagia-free survival was 98 days [95% CI: 68–123]. Most adverse events could be managed conservatively; however, a patient with BES after chemoradiotherapy (CRT) developed an esophago-left atrium fistula and died approximately 4 months after stent placement.

Conclusion

The BDS was effective for refractory BES and the safety was acceptable. However, the indication for this procedure in patients RECEIVING CRT for esophageal cancer should be carefully considered.

 

食道癌根治治療後の難治性良性食道狭窄に対する生分解性ステントの前向き試験 Prospective trial of biodegradable stents for refractory benign esophageal strictures after curative treatment of esophageal cancer

Tomonori Yano, MD ∙ Yusuke Yoda, MD ∙ Shogo Nomura, MS ∙ … ∙ Satoru Nonaka, MD, PhD ∙ Kazuhiro Kaneko, MD, PhD ∙ Akihiro Sato, MD, PhD …
Gastrointestinal Endoscopy  Published:January 27, 2017
DOI:https://doi.org/10.1016/j.gie.2017.01.011

Abstract

Background and Aims

Biodegradable stents are reportedly effective for refractory benign esophageal strictures; however, little is known about their use in patients with refractory stricture after endoscopic submucosal dissection (ESD) or chemoradiotherapy (CRT) for esophageal cancer. This study aimed to evaluate the effectiveness of biodegradable stents for these patients.

Methods

Patients with refractory benign esophageal stricture with a dysphagia score (DS) of 2 or worse and for whom the passage of a standard size endoscope was not possible were eligible. The primary endpoint was the proportion of those who improved their DSs (% DS improved) at 12 weeks after stent placement, and the secondary endpoints were the proportion of those who improved their DSs at 24 weeks, dysphagia-free survival (DFS), and adverse events.

Results

Eighteen patients (men:women, 15:3; median age, 72 years; range, 53-80) were enrolled. Twelve patients improved their DS at 12 weeks (% DS improved, 66.7%; 90% CI, 44.6%-84.4%). Also, 8 of 11 patients (72.7%) after esophagectomy, 4 of 6 patients (66.7%) after ESD, and 3 of 4 patients (75%) after CRT improved at 12 weeks. Three patients who were treated with esophagectomy maintained their DS improvement at 24 weeks (% DS improved, 16.7%; 95% CI, 3.6%-41.4%). The median DFS was 14.1 weeks (95% CI, 13.0-19.0). One patient who had ESD and CRT developed an esophagobronchial fistula 3 months after stent placement.

Conclusions

Biodegradable stents are effective and tolerable for refractory benign esophageal strictures after treatment for esophageal cancer; however, long-term efficacy was limited, especially after ESD or CRT. (Clinical trial registration number: UMIN000008054.)

医療・健康
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