- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07926490
Risk Factors for Postoperative Outcomes and Complications in Patients With Large Intrathoracic Tumors: A Multicenter Analysis
Risk Factors for Outcomes and Postoperative Complications in Patients with Large Intrathoracic Neoplasms (GIANTOR) What is the purpose of this study? The main goal of this study is to evaluate the results of surgery for removing very large tumors inside the chest. While common lung cancers are well-studied, other types of chest tumors (like solitary fibrous tumors or nerve-related tumors) can grow slowly and reach a massive size (over 5 cm) before they are found. Because these cases are rare, there is little data on the best way to operate on them. Researchers want to identify the risks and complications associated with these surgeries to improve patient care.
Why is this study important? Operating on large chest tumors is technically difficult because they often press against or grow into nearby vital organs. Currently, doctors mostly rely on reports of single cases rather than large groups of patients. This study will look at a large multicenter group to provide more reliable information on surgical techniques (such as open surgery vs. minimally invasive) and long-term recovery.
Who can participate in this study? The study includes patients who meet the following criteria:Adults aged 18 years or older.Patients with intrathoracic tumors measuring 5 cm or larger.Tumors that can be either benign (non-cancerous) or malignant (cancerous).Patients who underwent surgery with the intent to completely remove the tumor.The study excludes patients with common non-small cell lung cancer (NSCLC), thymomas, or sarcomas of the chest wall.
How is the study designed? This is a multicenter, retrospective and prospective cohort study. It is led by the IRCCS Azienda Ospedaliero-Universitaria di Bologna and involves six other major thoracic surgery centers in Italy (Rome, Padua, Turin, Pisa, and Milan).Researchers will review medical records of approximately 400 patients who had surgery between January 2005 and December 2024. Data will be collected on:Surgical complications during and after the operation.The type of surgical access used.Patient survival and disease recurrence.
What are the expected outcomes? Researchers hope to:Determine the rate of complications and deaths related to the surgery.Find specific risk factors (like patient health or tumor size) that lead to more complications.Compare different surgical methods to see which works best for large tumors.Measure long-term survival and how long patients stay free of disease after surgery.The results will be shared through scientific journals and international conferences to help surgeons worldwide manage these complex cases more safely.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Pietro Bertoglio, MD
- Numéro de téléphone: 0516478362
- E-mail: pietro.bertoglio@aosp.bo.it
Lieux d'étude
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Bologna
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Bologna, Bologna, Italie, 40138
- Recrutement
- IRCSS Azienda Ospedaliero-Universitaria di Bologna
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Contact:
- Pietro Bertoglio, MD
- Numéro de téléphone: 0516478362
- E-mail: pietro.bertoglio@aosp.bo.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study population consists of patients who underwent surgery for large intrathoracic tumors at the participating centers between January 2005 and December 2024. Subjects will be identified through a review of medical records, surgical registries, and outpatient documentation available at the participating facilities, and enrollment will take place during scheduled outpatient follow-up visits or via telephone contact made during postoperative follow-up, in accordance with the standard care pathway. In both cases, patient selection will be conducted in accordance with the inclusion and exclusion criteria established in the protocol, following verification of the available clinical documentation.
La description
Inclusion Criteria:
- Age ≥ 18 years
- Intrathoracic tumors ≥ 5 cm in size
- Tumors with either benign or malignant histology
- Tumors treated surgically with the aim of complete resection
Exclusion Criteria:
- NSCLC
- Thymomas
- Wall sarcomas
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: RETROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Intraoperative complication rate, postoperative complication rate
Délai: baseline
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baseline
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Relationship between the development of complications and the presence of pre- or intraoperative risk factors
Délai: baseline
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baseline
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Perioperative mortality rate
Délai: baseline
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baseline
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Rate of surgical approach utilization
Délai: baseline
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baseline
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Overall Survival and Disease-Free Survival
Délai: baseline
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baseline
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association of surgical approach utilization with postoperative complications
Délai: baseline
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baseline
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- GIANTOR
Informations sur les médicaments et les dispositifs, documents d'étude
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