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Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma (PROIHSTOP)

2026年6月18日 更新者：Yi Ji、West China Hospital

Rebound Growth After Abrupt Discontinuation Versus Gradual Tapering of Propranolol in Infantile Hemangioma: A Multicenter Randomized Noninferiority Trial

Infantile hemangioma is the most common benign vascular tumor in infancy. Oral propranolol is the first-line systemic treatment for infantile hemangiomas requiring therapy. Although most patients respond well to propranolol, rebound growth may occur after treatment discontinuation, and some patients may require restarting propranolol or receiving additional treatment. In clinical practice, propranolol may be discontinued abruptly after the lesion meets discontinuation criteria, or gradually tapered over several weeks before complete discontinuation. However, high-quality randomized evidence comparing these two discontinuation strategies remains limited.

This multicenter randomized noninferiority trial aims to compare the risk of rebound growth after abrupt discontinuation versus gradual tapering of propranolol in patients with infantile hemangioma who have received oral propranolol for at least 6 months and meet predefined discontinuation criteria.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

This is a prospective, multicenter, randomized, parallel-group, noninferiority trial designed to evaluate whether abrupt discontinuation of propranolol is noninferior to gradual tapering with respect to rebound growth in infantile hemangioma.

Eligible participants will be patients clinically diagnosed with infantile hemangioma who have received oral propranolol treatment for at least 6 months and meet predefined criteria for treatment discontinuation. The discontinuation criteria include complete or near-complete clinical regression of the lesion, no obvious blood flow on ultrasound, and maintenance of maximal regression for 3 months. Participants will be randomly assigned in a 1:1 ratio to either the abrupt discontinuation group or the gradual tapering group.

Participants in the abrupt discontinuation group will stop propranolol immediately after meeting the predefined discontinuation criteria. Participants in the gradual tapering group will receive half of the original total daily dose for the first 2 weeks, followed by one quarter of the original total daily dose for another 2 weeks, and propranolol will be discontinued in week 5.

All participants will be followed for at least 3 months after propranolol discontinuation. Demographic data, infantile hemangioma characteristics, treatment history, lesion size and color before and after treatment, rebound growth, major rebound growth, adverse events after discontinuation, age at rebound, interval from discontinuation to rebound, treatment after rebound, and parental satisfaction will be collected. Rebound growth will be assessed using standardized photographs and/or ultrasound by blinded outcome assessors.

The primary outcome is the proportion of participants with rebound growth after propranolol discontinuation. Rebound growth is defined as more than 20% regrowth in the external appearance of the infantile hemangioma, including changes in color and/or volume. Secondary outcomes include the proportion of participants with major rebound growth, age at rebound, time from discontinuation to rebound, treatment after rebound, adverse events after discontinuation, and parental satisfaction. Major rebound growth is defined as rebound growth requiring modification of oral propranolol treatment, including dose adjustment or restarting propranolol.

The planned sample size is 110 participants, with 55 participants in each group, allowing for an anticipated loss to follow-up rate.

研究の種類

介入

入学 (推定)

110

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • West China Hospital of Sichuan University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Children with a clinical diagnosis of infantile hemangioma.
  2. Complete pretreatment clinical documentation is available, including clinical photographs and/or ultrasound findings.
  3. The child has received oral propranolol for at least 6 months.
  4. The infantile hemangioma meets the predefined criteria for propranolol discontinuation, defined as complete or near-complete clinical regression, no obvious residual blood flow on ultrasound, and stable maximal regression for 3 months.
  5. Written informed consent is provided by a parent or legal guardian.
  6. The parent or legal guardian is able and willing to complete the scheduled follow-up assessments.

Exclusion Criteria:

  1. Airway or hepatic infantile hemangiomas, or other high-risk lesions for which rebound growth could rapidly compromise life or vital organ function.
  2. Use of propranolol for arrhythmia, hypertension, or another cardiovascular indication.
  3. A history of rebound growth after prior discontinuation of propranolol.
  4. Laser therapy, sclerotherapy, surgery, systemic corticosteroids, or other systemic treatment within 3 months before randomization.
  5. Severe cardiac, respiratory, hepatic, renal, metabolic, or other systemic disease that may affect participant safety or study assessment.
  6. Inability to complete standardized photography, ultrasound assessment, or scheduled follow-up.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Abrupt Discontinuation Group
Participants assigned to this group will discontinue propranolol abruptly after meeting predefined discontinuation criteria for infantile hemangioma.
薬：Abrupt Discontinuation of Propranolol
Propranolol will be stopped immediately once the participant meets predefined discontinuation criteria, including complete or near-complete clinical regression, no obvious blood flow on ultrasound, and maintenance of maximal regression for 3 months.
アクティブコンパレータ：Gradual Tapering Group
Participants assigned to this group will undergo gradual tapering of propranolol before complete discontinuation after meeting predefined discontinuation criteria for infantile hemangioma.
薬：Gradual Tapering of Propranolol
The propranolol dose will be reduced to half of the original total daily dose for the first 2 weeks, then reduced to one quarter of the original total daily dose for another 2 weeks, and propranolol will be discontinued in week 5.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Rebound Growth Following Propranolol Discontinuation
時間枠：Up to 3 months after complete discontinuation of propranolol
Rebound growth is defined as a greater than 20% increase in the visible extent of the infantile hemangioma after propranolol has been stopped, including change in color and/or volume. Rebound growth will be assessed by blinded outcome assessors using standardized clinical photographs and/or ultrasound.
Up to 3 months after complete discontinuation of propranolol

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to Rebound Growth
時間枠：Up to 3 months after complete discontinuation of propranolol
Time to rebound growth will be defined as the interval from complete discontinuation of propranolol to the first documented evidence of rebound growth.
Up to 3 months after complete discontinuation of propranolol
Age at Rebound Growth
時間枠：Up to 3 months after complete discontinuation of propranolol
Age at rebound growth will be recorded as the participant's age at the first documented evidence of rebound growth.
Up to 3 months after complete discontinuation of propranolol
Post-Rebound Treatment
時間枠：Up to 3 months after complete discontinuation of propranolol
Treatment after rebound growth will be recorded, including observation, propranolol dose adjustment, reinitiation of propranolol, topical therapy, laser therapy, surgery, or other treatment.
Up to 3 months after complete discontinuation of propranolol
Incidence of Clinically Significant Rebound Growth
時間枠：Up to 3 months after complete discontinuation of propranolol
Clinically significant rebound growth is defined as rebound growth that leads to a change in oral propranolol management, including dose adjustment or reinitiation of propranolol.
Up to 3 months after complete discontinuation of propranolol

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

West China Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年12月30日

研究の完了 (推定)

2028年3月30日

試験登録日

最初に提出

2026年6月18日

QC基準を満たした最初の提出物

2026年6月18日

最初の投稿 (実際)

2026年6月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月24日

QC基準を満たした最後の更新が送信されました

2026年6月18日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • RCT20260618

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be publicly shared because the dataset includes sensitive pediatric clinical information, clinical photographs, and ultrasound data. De-identified aggregate data may be made available from the principal investigator upon reasonable request and with appropriate ethical approval.

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米国FDA規制機器製品の研究

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