SURGICAL DEBULKING PLUS OCTREOTIDE VERSUS OCTREOTIDE ALONE IN ACROMEGALY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项多中心、研究者发起的随机研究，比较单用长效奥曲肽（山多他汀）治疗肢端肥大症与手术降压加奥曲肽治疗肢端肥大症，以确定手术降压是否能改善治疗效果。目前可用的治疗方法（手术、生长抑素类似物）的数据通常难以比较，也没有完成随机试验。受试者将随机分为A组或B组（1:2的比例）。A组从单独的药物治疗开始：患者接受3次剂量的桑多他汀治疗。B组仅从手术治疗开始。如果手术后患者没有治愈，患者将继续服用三剂山多他汀（超过3个月）。终点是功能测量（IGF-I）和肿瘤大小（MRI）。这项研究可能会导致患者初始治疗的改变，因为这种类型的大腺瘤的手术不是初始治疗。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter, investigator-initiated randomized study of long-acting octreotide (Sandostatin) alone vs. surgical debulking plus octreotide in acromegaly to determine if surgical debulking improves treatment effect. Data on currently available treatments (surgery, somatostatin analogs) are often difficult to compare, and no randomized trials have been completed. Subjects will be randomized to Arm A or B (1:2 ratio). Arm A begins with medical treatment alone: Patients are followed for 3 doses on Sandostatin. Arm B begins with surgical treatment alone. If after surgery the patient is not cured, the patient will go on Sandostatin for 3 doses (over 3 months). Endpoints are functional measures (IGF-I) and tumor size (MRI). The study may lead to a change in the initial management of patients, because surgery of macroadenomas of this sort is not initial treatment.