MINIMALLY INVASIVE SURGERY IN CHILDREN WITH CANCER

癌症儿童的微创手术

• 批准号: 2108000
• 负责人: GEORGE W HOLCOMB
• 金额: $ 12.11万
• 依托单位: NATIONAL CHILDHOOD CANCER FOUNDATION
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-20 至 1998-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2108000
• 关键词: child (0-11); clinical trials; cooperative study; health care cost /financing; human subject; human therapy evaluation; neoplasm /cancer surgery; pediatric neoplasm /cancer; postoperative state; prognosis; questionnaires; statistics /biometry

Minimally invasive surgery (MIS) is being rapidly applied to many adult and pediatric surgical conditions. The prevailing atmosphere has been consumer-driven to the point that traditional evaluation processes have been severely limited or bypassed completely. Most reports are single author or institutional anecdotal assessments with few controlled appraisals of safety and efficacy. New indications within the domain of surgical oncology have been proposed for MIS which would supplant the standard open thoracic and abdominal procedures. While most of these have been referable to adult patients, the role of MIS in the management of children with cancer is currently unknown and must be carefully evaluated. Because pediatric solid tumors are rare, a large consortium of pediatric institutions will be required to adequately study this new technology. The Childrens Cancer Group (CCG) is such a multi-institutional, multidisciplinary cooperative group which has a long-standing track record in the successful completion of this type of complex clinical trial. The CCG Surgery Discipline Committee is well known for its structure, organization, academic productivity and quality control mechanisms to support such an effort. Also the committee has a uniquely documented, broad-based expertise in MIS technology as required by the protocol. This study proposes to determine the role of MIS in the management of pediatric cancer by testing three hypotheses: 1) MIS is a safe and practical procedure in children with cancer; 2) MIS is as efficacious as standard open surgical operations for the diagnosis, staging and assessment of resectability of pediatric solid tumors; and 3) MIS will improve recovery and convalescence of children with cancer and decrease the cost of care. The specific aims related to hypothesis #1 will be evaluated in a phase Il investigation format during year one of the study. If this hypothesis is validated, the specific goals used to test hypothesis #2 and #3 will be analyzed in a prospective randomized phase Ill protocol of MIS versus traditional surgical techniques. This will require approximately two years to accomplish. The following proposal is intended to respond to RFA #CA-93-032 and will outline the significance of the study, experience of the CCG surgeons, preeminent expertise of the Principal Investigator, research goals and design, specific study methodology, necessary statistical analyses, requested budget justification and required supporting documents.

微创手术（MIS）正在迅速应用于许多成年人 和小儿手术状况。 盛行的气氛已经 消费者驱动的地步，传统评估过程 受到严格限制或完全绕过。大多数报告是单个报告 作者或机构轶事评估很少受控 对安全性和有效性的评估。 已经提出了手术肿瘤学领域内的新指示 对于那些将取代标准的开放式胸腔和腹部的MIS 程序。虽然其中大多数已转介给成年患者，但 MIS在癌症儿童管理中的作用目前尚不清楚 并且必须仔细评估。 因为小儿实体瘤很少见，所以小儿大联盟 将需要机构充分研究这项新技术。这 儿童癌组（CCG）是一种多机构的， 多学科合作小组，有长期的记录 在成功完成此类复杂临床试验中。这 CCG手术学科委员会以其结构而闻名 组织，学术生产力和质量控制机制 支持这样的努力。委员会也有一个独特的记录， 协议要求的基于MIS技术的广泛专业知识。 这项研究建议确定MIS在管理中的作用 通过检验三个假设来小儿癌：1）MIS是安全的，并且 癌症儿童的实际程序； 2）MIS像 标准的开放手术手术，用于诊断，分期和 评估小儿实体瘤的可察； 3）MIS意志 改善癌症儿童的康复和康复 护理费用。 与假设1有关的具体目的将在IL阶段进行评估 研究格式在研究的第一年。 如果这个假设是 经过验证，用于检验假设2和＃3的特定目标将是 通过MIS与 传统的手术技术。这将需要大约两年 完成。 以下建议旨在回应RFA＃CA-93-032，并将 概述研究的重要性，CCG外科医生的经验， 主要研究者，研究目标和 设计，特定的研究方法，必要的统计分析， 要求预算辩护，并需要支持文件。