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临床试验/NCT07405099
NCT07405099Enrolling By Invitation不适用

The Analysis of End-stage Renal Disease for Outcomes in Pancreatic Surgery

National Taiwan University Hospital0 个研究点目标入组 100 人开始时间: 2016年1月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
主要终点
Rate of clinically relevant POPF and Clavian Dindo IIIA or higher complication

研究概览

简要总结

End-stage renal disease (ESRD) patients often present risk factors for many surgical complications. The severity of renal failure and whether the patient is receiving renal replacement therapy are also related to the difficulty of pancreatic and other major surgeries, causing many ESRD patients to hesitate when choosing surgery. Therefore, this project aims to retrospectively collect basic data, preoperative and postoperative blood tests (blood cell counts, biochemistry, tumor markers, glucose-related, lipid-related), and preoperative and postoperative imaging examinations (CT, MRI, Ultrasound, PET scan, Endoscopy, etc.) of ESRD patients who underwent pancreatic surgery at our hospital. We aim to compare whether surgical methods, severity of renal failure, use of renal replacement therapy, and lesion margin clearance rates affect the occurrence of surgical complications, length of hospital stay, length of ICU stay, re-operation rates or severe complications, medical costs, and related quality of life. This analysis is intended to understand and analyze the surgical prognosis, care priorities, common complications, and the management and outcomes of our team for ESRD patients undergoing pancreatic surgery, with the expectation of providing more diverse and specific treatment recommendations for these patients in the future.

详细描述

Background End-stage renal disease patients often present risk factors for many surgical complications. However, the severity of renal failure and whether the patient is receiving renal replacement therapy are also related to the difficulty of pancreatic and other major surgeries, causing many end-stage renal disease patients to hesitate when choosing surgery options.

IV. Objectives To compare whether surgical methods, severity of renal failure, use of renal replacement therapy, and lesion margin clearance rates affect the patient's occurrence of surgical complications, length of hospital stay, length of ICU stay, re-operation or severe complications, medical costs, and related quality of life.

V. Methodology and Procedures Data Collection The Principal Investigator and Co-Investigator will retrospectively review medical records to collect basic data of patients with end-stage renal disease who underwent pancreatic surgery at this hospital. This includes preoperative and postoperative blood tests (blood counts, biochemistry, tumor markers, glucose-related, lipid-related) and imaging examinations (CT, MRI, Ultrasound, PET scan, Endoscopy, etc.). This data will be used to compare the impact of surgical methods, renal failure severity, renal replacement therapy status, and margin clearance on surgical complications, hospital stay, ICU stay, re-operations, severe complications, medical costs, and quality of life. The goal is to analyze the prognosis, care priorities, and management outcomes for ESRD patients undergoing pancreatic surgery.

From the hospital portal system, approximately 500 medical records of patients with pancreatic diseases who underwent pancreatic surgery or invasive treatment performed by the Principal Investigator and Co-Investigator between January 2005 and July 2021 will be collected. This observational study will collect routine imaging and laboratory tests performed at the hospital to analyze treatment indications, surgical indicators, and prognosis.

Inclusion Criteria:

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Males or females aged between 20 and 75 years.
  • Patients scheduled to undergo pancreatic surgery.

排除标准

  • Patients under 20 or over 75 years of age at this hospital.
  • Presence of other active malignancies prior to diagnosis.
  • Minors, pregnant women, breastfeeding women, and patients with psychiatric disorders.

结局指标

主要结局

Rate of clinically relevant POPF and Clavian Dindo IIIA or higher complication

时间窗: within 6 months after operation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

National Taiwan University Clinical Trial Center

Clinical Professor

National Taiwan University Hospital

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