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一项前瞻性多中心对照研究的结果:比较显微镜下与全内镜经蝶窦手术治疗无功能性垂体腺瘤的手术效果——经蝶窦切除范围(TRANSSPHER)研究

Results of a prospective multicenter controlled study comparing surgical outcomes of microscopic versus fully endoscopic transsphenoidal surgery for nonfunctioning pituitary adenomas: the Transsphenoidal Extent of Resection (TRANSSPHER) Study.

作者信息

Little Andrew S, Kelly Daniel F, White William L, Gardner Paul A, Fernandez-Miranda Juan C, Chicoine Michael R, Barkhoudarian Garni, Chandler James P, Prevedello Daniel M, Liebelt Brandon D, Sfondouris John, Mayberg Marc R

机构信息

1Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona.

2Pacific Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute at Providence Saint John's Health Center, Santa Monica, California.

出版信息

J Neurosurg. 2019 Mar 22;132(4):1043-1053. doi: 10.3171/2018.11.JNS181238. Print 2020 Apr 1.

Abstract

OBJECTIVE

Many surgeons have adopted fully endoscopic over microscopic transsphenoidal surgery for nonfunctioning pituitary tumors, although no high-quality evidence demonstrates superior patient outcomes with endoscopic surgery. The goal of this analysis was to compare these techniques in a prospective multicenter controlled study.

METHODS

Extent of tumor resection was compared after endoscopic or microscopic transsphenoidal surgery in adults with nonfunctioning adenomas. The primary end point was gross-total tumor resection determined by postoperative MRI. Secondary end points included volumetric extent of tumor resection, pituitary hormone outcomes, and standard quality measures.

RESULTS

Seven pituitary centers and 15 surgeons participated in the study. Of the 530 patients screened, 260 were enrolled (82 who underwent microscopic procedures, 177 who underwent endoscopic procedures, and 1 who cancelled surgery) between February 2015 and June 2017. Surgeons who used the microscopic technique were more experienced than the surgeons who used the endoscopic technique in terms of years in practice and number of transsphenoidal surgeries performed (p < 0.001). Gross-total resection was achieved in 80.0% (60/75) of microscopic surgery patients and 83.7% (139/166) of endoscopic surgery patients (p = 0.47, OR 0.8, 95% CI 0.4-1.6). Volumetric extent of resection, length of stay, surgery-related deaths, and unplanned readmission rates were similar between groups (p > 0.2). New hormone deficiency was present at 6 months in 28.4% (19/67) of the microscopic surgery patients and 9.7% (14/145) of the endoscopic surgery patients (p < 0.001, OR 3.7, 95% CI 1.7-7.7). Microscopic surgery cases were significantly shorter in duration than endoscopic surgery cases (p < 0.001).

CONCLUSIONS

Experienced surgeons who performed microscopic surgery and less experienced surgeons who performed endoscopic surgery achieved similar extents of tumor resection and quality outcomes in patients with nonfunctioning pituitary adenomas. The endoscopic technique may be associated with lower rates of postoperative pituitary gland dysfunction. This study generally supports the transition to endoscopic pituitary surgery when the procedure is performed by proficient surgeons, although both techniques yield overall acceptable surgical outcomes.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: prospective cohort trial; evidence: class III.Clinical trial registration no.: NCT02357498 (clinicaltrials.gov).

摘要

目的

许多外科医生已采用全内镜经蝶窦手术而非显微镜下经蝶窦手术来治疗无功能性垂体瘤,尽管尚无高质量证据表明内镜手术能带来更优的患者预后。本分析的目的是在前瞻性多中心对照研究中比较这两种技术。

方法

比较成人无功能性腺瘤患者在内镜或显微镜下经蝶窦手术后的肿瘤切除范围。主要终点是术后MRI确定的肿瘤全切除。次要终点包括肿瘤切除的体积范围、垂体激素结果和标准质量指标。

结果

7个垂体中心和15名外科医生参与了该研究。在2015年2月至2017年6月期间,对530例筛查患者中的260例进行了入组(82例接受显微镜手术,177例接受内镜手术,1例取消手术)。在从业年限和经蝶窦手术例数方面,使用显微镜技术的外科医生比使用内镜技术的外科医生经验更丰富(p<0.001)。显微镜手术患者中有80.0%(60/75)实现了肿瘤全切除,内镜手术患者中有83.7%(139/166)实现了肿瘤全切除(p = 0.47,OR 0.8,95%CI 0.4 - 1.6)。两组之间的切除体积范围、住院时间、手术相关死亡和非计划再入院率相似(p>0.2)。显微镜手术患者中有28.4%(19/67)在6个月时出现新的激素缺乏,内镜手术患者中有9.7%(14/145)出现新的激素缺乏(p<0.001,OR 3.7,95%CI 1.7 - 7.7)。显微镜手术的持续时间明显短于内镜手术(p<0.001)。

结论

经验丰富的进行显微镜手术的外科医生和经验较少的进行内镜手术的外科医生在无功能性垂体腺瘤患者中实现了相似的肿瘤切除范围和质量结果。内镜技术可能与较低的术后垂体功能障碍发生率相关。本研究总体上支持在由熟练外科医生进行手术时向内镜垂体手术的转变,尽管两种技术都产生了总体可接受的手术结果。■证据分类问题类型:治疗性;研究设计:前瞻性队列试验;证据:III级。临床试验注册号:NCT02357498(clinicaltrials.gov)

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