THE UNSUSPECTED SMALL STONE STUDY (USSS)

意想不到的小石头研究（USSS）

• 批准号: 6194022
• 负责人: James A. DiSario
• 金额: $ 7.48万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-08-15 至 2001-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6194022
• 关键词: cholangiography; cholecystectomy; cholelithiasis; clinical research; health care cost /financing; human morbidity; human mortality; human subject; human therapy evaluation; information systems; jaundice; liver function; longitudinal human study; outcomes research; pain; patient care management; quality of life; therapy; ultrasonography

DESCRIPTION (adapted from the application) Gallstones are the most common and the most costly digestive disease, with an annual estimated expenditure of 5 billion dollars. Fifteen percent of persons with symptomatic gallstones will have concomitant bile duct stones (BDS). Expert opinion varies, but there are several reports of leaving BDS in situ without adverse outcomes. The aim of this proposal is to determine if conservative or expectant management is a safe and effective therapy for patients with unsuspected small BDS found at intraoperative cholangiography (10C) during laparoscopic cholecystectomy (LC), compared to conventional therapy with endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy (ES). This is a randomized, prospective, multicenter study of patient outcomes and treatment costs. The primary endpoint is overall morbidity I year after randomization. Secondary endpoints include rates of severe morbidity, mortality, abdominal pain, jaundice, abnormal serum liver tests, abnormal transcutaneous abdominal ultrasound examinations, quality of life indices, and overall treatment costs. A database will be established for long-term follow up. The duration of the study is aimed to be 2 years from the onset of funding. One hundred and eighty two (91 per group) patients will be randomized to have expectant management or to have ERCP with sphincterotomy and stone extraction. Eligibility requirements include no history of jaundice, pancreatitis, or cholangitis, and <3 BDS, < 5 mm in diameter found by intraoperative imaging. Follow up will be by standardized interview at 1, 6, and 12 months. Persons in the both expectant and treatment groups will have serum liver tests at 6 and 12 months, post-LC or post-ERCP respectively. The expectantly managed group will have transabdominal ultrasound at 12 months. Expectantly managed individuals with abnormal results will have ERCP. Statistical power for detecting differences will be emphasized (beta=0.01, alpha=0.05). This proposal will allow the investigators to explore an important clinical question, expand a previously constructed study framework to become an interdisciplinary study group including gastroenterologists and surgeons, and to refine and validate study operational systems. Should there be nonsignificant trends detected in the results with the proposed sample size, we intend to proceed with a larger scale multicenter study proposal. The study group and systems developed in this proposal will be used for future multicenter projects on gallstone disease.

描述（改编自应用程序） 胆结石是最常见和最昂贵的消化系统疾病， 1997年，美国的出口额为150亿美元。百分之十五的人 有症状的胆结石患者将伴随胆管结石（BDS）。 专家意见各不相同，但有几份报告称， 没有不良后果。本提案的目的是确定， 保守或期待治疗是一种安全有效的治疗方法， 术中胆管造影发现意外小BDS的患者 (10C)腹腔镜胆囊切除术（LC）中，与传统 内镜逆行胰胆管造影术（ERCP）治疗， 括约肌切开术。 这是一项关于患者结局的随机、前瞻性、多中心研究， 治疗费用。主要终点是治疗后1年的总体发病率。 随机化次要终点包括严重发病率， 死亡率、腹痛、黄疸、血清肝脏检查异常、异常 经皮腹部超声检查、生活质量指数，以及 整体治疗费用。将建立数据库进行长期跟踪 起来研究的持续时间目标是从资金开始算起2年。 182例（每组91例）患者将随机接受 保守治疗或ERCP括约肌切开取石。 资格要求包括无黄疸、胰腺炎或 胆管炎，术中影像学检查发现胆道狭窄<3例，直径<5 mm。 随访将在1、6和12个月时通过标准化访谈进行。人 期待组和治疗组将在6点和12点进行血清肝脏检查， 分别为LC后或ERCP后3个月。预期管理组将 12个月时做经腹超声检查期望管理的个人 结果异常的患者将接受ERCP检查。检测统计功效 将强调差异（β = 0.01，α = 0.05）。 这项提案将使研究人员能够探索一个重要的临床 问题，扩大以前构建的研究框架，成为一个 包括胃肠病学家和外科医生在内的跨学科研究小组， 完善和验证研究操作系统。如果有 我们在拟议样本量的结果中检测到非显著趋势， 打算进行更大规模的多中心研究提案。研究 本提案中开发的组和系统将用于未来 胆石病的多中心项目。