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临床试验/NCT04755036
NCT04755036已完成不适用

National Survey and Case-vignette Study of Clinical Decisions in Pancreatic Cancer

Hospital Miguel Servet1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2020年1月1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
69
试验地点
1
主要终点
Measurement of consensus in therapeutical decisions in pancreatic cancer between low/mid vs high volume hospitals

研究概览

简要总结

Very few surveys have been carried out about oncosurgical decisions made in patients with pancreatic cancer (PC), and none have established whether the therapeutic approaches differ between low/medium and high volume centers.

A survey was sent out to centers from Spanish Group of Pancreatic Surgery (GECP) asking about usual pre, intra and postoperative management of PC patients and describing five imaginary cases of PC corresponding to common scenarios that surgeons regularly assess in oncosurgical meetings. Investigators define consensus when 80% of answers were equal.

详细描述

In 2019, the Hepato-Pancreato-Biliary Surgery Section of the Spanish Association of Surgeons and the Spanish Chapter of the IHPBA created the Spanish Group of Pancreatic Surgery (henceforth, GECP). The GECP notified the associates of both societies about the creation of the group by email, and also made announcements on their respective web pages. The GECP comprises a council of eight people. On applying to join, hospitals appoint a contact person who receives information on the work of the group, which is carried out on a multicenter basis. Currently, 72 hospitals are part of the GECP. GECP members perform 78% of PDs throughout Spain.

In January 2020, a survey was sent out to the local surgeon manager of each GECP center, describing decisions in pre, intra, and postoperative management of patients with PC undergoing PD and five imaginary cases of patients with PC in the pancreatic head corresponding to five common scenarios that surgeons regularly assess in multidisciplinary oncological meetings (MDTB). It was explained in the cover letter that respondents' answers should not necessarily be the ones that appear in the textbooks or clinical guidelines but should reflect standard clinical practices at their centers. In the interests of objectivity, it was decided that the responses should be anonymous. The questions about decisions and cases were devised by the first author and sent to the seven other members of the GECP organizing committee who evaluated them and finally agreed on their definitive format. The cases presented were: resectable PC without vascular invasion, resectable PC with venous invasion below 180º, borderline PC with venous invasion above 180º, PC with arterial invasion below 180º and severe venous invasion, and PC with liver metastases.

Investigators classified hospital level divided as follows (level 1: 0-250 beds or area <200,000 inhabitants; level 2: 251-500 beds or area <400,000; level 3: > 500 beds or area> 400,000); whether liver transplantation is performed at the center (to assess whether greater experience in vascular reconstruction affected intraoperative vascular management); the number of hospital beds; the number of pancreaticoduodenectomies (PD), distal pancreatectomies (DP) and total pancreatectomies (TP) performed at each center in 2018; and data on the surgeon who completed the survey including age, gender, position and years of experience in pancreatic surgery. Respondents were given a period of 60 days to submit their replies.

The data were collected through an electronic survey using Google Forms and were analyzed with the R statistical software (https://www.r-project.org/). Categorical variables were expressed as number of cases and percentages. For continuous variables, normality was assessed with the Shapiro-Wilk test. Variables that were normal were expressed by means and standard deviation, while those that deviated from normality were expressed with medians and interquartile range. As contrast tests, the chi-square test with Yates correction was used for categorical variables, and the Student's t test and the Mann-Whitney U test for continuous normal and non-normal variables respectively. We defined the existence of a common national criterion when 80% of the respondents applied the same clinical practice.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Resposnible for each center of GECP

排除标准

  • 未提供

结局指标

主要结局

Measurement of consensus in therapeutical decisions in pancreatic cancer between low/mid vs high volume hospitals

时间窗: Survey sent in 2020. Time to receive surveys up to 12 weeks

Percentage of consensus in therapeutical decisions. Difference (p\<0.05) (if exists) between high and low volume centers

次要结局

未报告次要终点

研究者

发起方
Hospital Miguel Servet
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Serradilla, MD, FACS

Senior Consultant in Department of Surgery

Hospital Miguel Servet

研究点 (1)

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