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临床试验/NCT04151394
NCT04151394已完成不适用

Side-to-side Duodenojejunostomy After Resection of Third and Fourth Duodenal Part With Pancreatic Preservation

Universidad de Extremadura1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
1
主要终点
Complication

研究概览

简要总结

Lower partial duodenectomy could be indicated in case of injury, wide neck diverticulum, tumor invasion by other tumors such as retroperitoneal sarcoma and primary tumor of 3rd and 4th portion of the duodenum. Reconstruction after resection is usually performed by a end-to-end or end-to-side anastomosis.

The investigators analyze the short and long-term results of a case series with resection for various lesions in the third and fourth duodenal portions and reconstruction of the intestinal transit through side-to-side duodenojejunostomy

详细描述

The investigators retrospectively looked at patients who, from January 2010 to December 2018, underwent surgical procedures for duodenal tumors or other type of primary lesions.

Patients with primary duodenal lesions who underwent surgery were included in the study. Patients with secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration were excluded. Similarly, if the surgeons appreciate the involvement of the pancreas during the procedure, for which they would have to perform a pancreaticoduodenectomy, the patient would be excluded.

Diagnostic management included establishment of a medical history, performance of clinical examination and imaging tests, including endoscopic exploration and, when neoplasm was suspected, computerized tomography (CT) scan, to confirm the tumor origin and growth, as well as infiltration, if any, of adjacent structures. These also allowed to rule out distant metastases, and to assess resectability and the option for reconstruction according to the location.

The variables taken into account were age, sex, the American Society of Anesthesiologists (ASA) classification, preoperative examinations performed and type of lesion susppected as benign, duodenal adenocarcinoma or gastrointestinal stromal tumor (GIST). Perioperative clinical results, surgical approach, type of resection and reconstruction, and intraoperative complications were recorded. Details of the postoperative course were collected. Some of the key short-term data recorded included length of hospital stay, complications' ranking (according to the Clavien-Dindo score; 'severe complication' is defined as greater or equal to IIIa), re-operation, re-admission and operative mortality (< 90 days after operation). Some of the key long-term data recorded were, digestive symptoms along follow-up, specific disease-free survival (DFS) and overall survival (OS)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary duodenal lesions who underwent surgery

排除标准

  • Secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration

结局指标

主要结局

Complication

时间窗: 90 days

Surgical complications rates

Overall survival

时间窗: 10 years

Patients overall survival after resection

次要结局

未报告次要终点

研究者

发起方
Universidad de Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerardo Blanco-Fernández

Head of Surgery, Clinical Professor

Universidad de Extremadura

研究点 (1)

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