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临床试验/NCT07446946
NCT07446946已完成不适用

Surgical Management of Pancreatic Cancer With Liver Metastasis (Oligometastasis)

Richard Hunger0 个研究点目标入组 68,303 人开始时间: 2010年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68,303
主要终点
30-Day in-hospital mortality

研究概览

简要总结

Pancreatic cancer is one of the most serious forms of cancer. When it has already spread to the liver, treatment usually consists of chemotherapy rather than surgery. However, in recent years, some hospitals have begun removing both the pancreatic tumor and liver metastases during the same operation in carefully selected patients. This approach remains controversial, and it is unclear how often it is performed in everyday clinical practice and whether it is safe.

The aim of this study was to better understand current practice patterns in Germany and to evaluate the short-term safety of simultaneous pancreatic and liver surgery. Using nationwide hospital data, we examined all adult patients who underwent pancreatic resection for a malignant pancreatic tumor over a 14-year period.

The study was designed to test several key hypotheses. First, we hypothesized that simultaneous resection of pancreatic tumors and liver metastases is not an exceptional event but is already being performed in routine clinical care. Second, we examined whether adding liver surgery increases the risk of dying during the hospital stay compared to pancreatic surgery alone. Third, we investigated whether the extent of liver resection (minor versus major anatomical procedures) influences perioperative risk. Finally, we assessed whether hospital experience and surgical case volume affect patient safety in this complex setting.

Because the data were derived from a nationwide administrative registry, the study focuses on short-term outcomes during hospitalization. It does not address long-term survival or the overall oncologic benefit of combined surgery. Instead, the purpose of this analysis is to provide objective real-world data on how frequently this surgical strategy is used and whether it appears to be feasible from a perioperative safety perspective.

详细描述

Study Design and Registry Framework This investigation represents a nationwide retrospective cohort study based on the German Diagnosis-Related Group (DRG) hospital discharge database covering the period 2010-2023. The DRG system constitutes a mandatory administrative registry capturing all inpatient hospitalizations across Germany, thereby providing full national coverage without center-level voluntary participation bias.

The registry includes patient demographics, ICD-10 diagnosis codes, OPS procedure codes, discharge status, and institutional identifiers. For this study, all adult patients (≥18 years) with a principal diagnosis coded as malignant neoplasm of the pancreas (ICD-10 C25) who underwent pancreatic resection were included.

Quality Assurance Plan The German DRG registry operates under a legally mandated standardized coding framework. Coding is performed by trained hospital coders and subject to institutional internal audits as well as external audits by health insurance funds and the Medical Service of Health Insurance (MD). Financial reimbursement is directly linked to coding accuracy, creating systematic incentives for data validity.

For this study:

Only validated national DRG datasets were used. Data were obtained from the Federal Statistical Office. All data were anonymized prior to analysis. Logical consistency checks were performed before statistical analysis. No site-level monitoring was required, as this is a population-based administrative dataset.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • C25 as primary diagnosis
  • pancreatic resection (OPS:5-524, 5-525)

排除标准

  • Missing data on age or sex
  • transplantation procedures
  • Patients with a total pancreatectomy following a partial pancreatic resection during the same hospitalization

研究组 & 干预措施

Pancreatic cancer with liver metastases

Primary diagnosis C25 and side diagnosis C78.7

Pancreatic cancer without liver metastases

Primary diagnosis C25 and without side diagnosis C78.7

结局指标

主要结局

30-Day in-hospital mortality

时间窗: 30 days

Postoperative death within 30 days after index surgery

Failure-to-Rescue

时间窗: Within 30 days after index surgery

Death after the occurrence of a major complication

次要结局

未报告次要终点

研究者

发起方
Richard Hunger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Richard Hunger

Researcher

Medizinische Hochschule Brandenburg Theodor Fontane

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