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Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy

2026年9月27日 更新者:Omar Anter Ali Abdelhamid、Assiut University

Development and Internal Validation of a Preoperative Risk Model for Clinically Relevant Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy

Postoperative pancreatic fistula (POPF) especially clinically relevant POPF (CR-POPF; Grades B and C) is one of the critical and challenging post pancreaticoduodenectomy complications. Despite advances in surgical techniques, perioperative care, and centralization of pancreatic surgery Postoperative pancreatic fistula (POPF) remains an important cause for postoperative morbidity and

研究概览

地位

尚未招聘

详细说明

Several risk prediction models have been developed to estimate the likelihood of CR-POPF, including the Fistula Risk Score (FRS), the Alternative Fistula Risk Score (a-FRS) and updated alternative Fistula Risk Score (ua-FRS). However, these models rely predominantly on intraoperative variables, such as pancreatic texture and main pancreatic duct diameter, limiting their value in preoperative risk stratification and patient counselling .

Despite the robustness of these scoring systems, certain aspects require further refinement. In particular, assessment of pancreatic texture remains largely subjective and dependent on intraoperative surgeon palpation, highlighting the need for more objective and quantitative methods. [3,4] Furthermore, elastography has emerged as a promising non-invasive technique for quantitative characterization of pancreatic tissue stiffness and has recently been investigated for preoperative prediction of clinically relevant postoperative pancreatic fistula; however, it has not yet been incorporated into the widely used fistula risk scoring systems.

Onodera's prognostic nutritional index (PNI) is calculated from serum albumin concentration and peripheral blood lymphocyte (PBL) count. It indicates the patient's nutritional and immunological status and is used to predict risk of several kinds of complications after surgery. Moreover, several preoperative nomograms and machine-learning models have demonstrated promising predictive performance for POPF. However, PNI has not been included in any of these scores.

Given the absence of an internally validated preoperative prediction model in the Egyptian population, this study aims to develop and internally validate a preoperative risk model for clinically relevant postoperative pancreatic fistula by incorporation of preoperative PNI and pancreatic texture assessment by elastography with previously emerged scores in patients undergoing pancreaticoduodenectomy. The proposed model may facilitate individualized risk stratification, optimize perioperative planning, improve patient counselling, and support evidence-based surgical decision-making

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Hisham Ali Riad Shaban Ali Riad Hisham Ali Riad Shaban, Professor of General Surgery
  • 电话号码:01005015757
  • 邮箱:heshamreyad@aun.edu.eg

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients undergoing elective pancreaticoduodenctomy

描述

Inclusion Criteria:

  • Adults (≥18 years).
  • Elective pancreaticoduodenectomy.
  • Benign or malignant periampullary and pancreatic lesions.

Exclusion Criteria:

  • - Total pancreatectomy.
  • Distal pancreatectomy.
  • Missing essential preoperative data.
  • Death within 24 hours after surgery.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
preoperative risk model for clinically relevant postoperative pancreatic fistula

preoperative risk model for clinically relevant postoperative pancreatic fistula by incorporation of preoperative PNI and pancreatic texture assessment by elastography with previously emerged scores in patients undergoing pancreaticoduodenectomy

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of clinically relevant postoperative pancreatic fistula
大体时间:Within 90 days after surgery

Proportion of patients developing clinically relevant postoperative pancreatic fistula (Grade B or C) following pancreaticoduodenectomy, according to the International Study Group of Pancreatic Surgery (ISGPS) definition.

Within 90 days after surgery
Discrimination of the preoperative prediction model
大体时间:Within 90 days after surgery

Area under the receiver operating characteristic curve (AUROC) for the preoperative prediction model in predicting clinically relevant postoperative pancreatic fistula.

Within 90 days after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月30日

初级完成 (估计的)

2028年9月30日

研究完成 (估计的)

2028年12月30日

研究注册日期

首次提交

2026年9月16日

首先提交符合 QC 标准的

2026年9月27日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月27日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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