The LYMPH Trial - Comparing Microsurgical with Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial
Notice bibliographique
Résumé
ABSTRACT Introduction Up to one fifth of breast cancer survivors will develop chronic breast cancer-related lymphedema (BCRL). To date complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomized trial aims to evaluate advantages of microsurgical interventions plus CDT vs CDT alone for BCRL treatment. Methods and analysis The effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. BCRL patients will be randomly allocated to either surgical or conservative therapy. The primary endpoint of this trial is the patient-reported quality of life (QoL) outcome “lymphedema-specific QoL”, which will be assessed 15 months after randomization. Secondary endpoints are further patient reported outcomes (PROs), arm volume measurements, economic evaluations, and imaging at different timepoints. A long-term follow-up will be conducted up to 10 years after randomization. A total of 280 patients will be recruited in over 20 sites worldwide. Ethics and dissemination This study will be conducted in compliance with the Declaration of Helsinki and the ICH-GCP E6 guideline. Ethical approval has been obtained by the lead Ethics Committee ‘Ethikkommission Nordwest- und Zentralschweiz‘ (2023–00733, 22.05.2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset’s type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the FAIR principles. Trial registration The trial is registered at https://clinicaltrials.gov (ID: NCT05890677 ) and on the Swiss National Clinical Trials Portal (SNCTP, BASEC project-ID: 2023-00733) at https://kofam.ch/de . The date of first registration was 23.05.2023. Strengths and limitations of this study - This is a pragmatic, randomized, international, multicentre, superiority trial, which has the potential to impact the clinical practice of therapy for patients with chronic BCRL. - The pragmatic design will reflect clinical practice, thereby directly providing applicable results. - A comprehensive long-term follow-up will be conducted, extending up to 10 years, to assess and analyze long-term outcomes. - Patient advocates were intensely involved throughout the trial design. - To date, no multicentric RCT has compared microsurgical techniques (LVA and VLNT) possibly combined with liposuction with CDT alone, thereby limiting patient’s access to available treatment options. - The assessment of treatment quality (both conservative and surgical) at various sites is challenging due to potential variations resulting from the pragmatic design, which may influence the study’s outcomes.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».