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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.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Bologna
      • Bologna、Bologna、意大利、40138
        • 招聘中
        • IRCSS Azienda Ospedaliero-Universitaria di Bologna
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:RETROSPECTIVE

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Intraoperative complication rate, postoperative complication rate
大体时间:baseline
baseline
Relationship between the development of complications and the presence of pre- or intraoperative risk factors
大体时间:baseline
baseline

次要结果测量

结果测量
大体时间
Perioperative mortality rate
大体时间:baseline
baseline
Rate of surgical approach utilization
大体时间:baseline
baseline
Overall Survival and Disease-Free Survival
大体时间:baseline
baseline
association of surgical approach utilization with postoperative complications
大体时间:baseline
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月30日

初级完成 (估计的)

2027年5月30日

研究完成 (估计的)

2027年5月30日

研究注册日期

首次提交

2026年7月20日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • GIANTOR

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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