跳至主要内容
临床试验/NCT07382791
NCT07382791招募中不适用

The Analysis of Delayed Gastric Emptying After Pancreatic Surgery

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
3,500
试验地点
1
主要终点
Length of nasogastric tube intubation after surgery

研究概览

简要总结

Delayed gastric emptying (DGE) is a common complication of pancreatic surgery. Once it occurs, it often affects the patient's postoperative quality of life and may even delay subsequent necessary treatments, such as adjuvant chemotherapy. 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 patients who underwent pancreatic surgery at our hospital. We aim to compare whether surgical methods, the placement of gastrointestinal feeding tubes, lesion margin clearance rates, and postoperative remnant pancreatic volume affect the occurrence of delayed gastric emptying and related quality of life. This analysis is intended to understand and analyze the risk factors for delayed gastric emptying in pancreatic surgery patients, the indications for gastrointestinal feeding tube placement, as well as the management and prognosis of delayed gastric emptying, with the expectation of providing more diverse and specific treatment recommendations for patients with delayed gastric emptying after pancreatic surgery in the future.

Keywords: Pancreatic surgery, Delayed gastric emptying, Gastrointestinal feeding tube III. Background Delayed Gastric Emptying after Pancreatic Surgery Delayed gastric emptying is a common complication of pancreatic surgery. However, once it occurs, it often affects the patient's postoperative quality of life and may even delay subsequent necessary treatments, such as adjuvant chemotherapy.

IV. Objectives To compare whether surgical methods, the placement of gastrointestinal feeding tubes, lesion margin clearance rates, and postoperative remnant pancreatic volume affect the occurrence of delayed gastric emptying and related quality of life in patients.

V. Methodology and Procedures Data Collection The Principal Investigator and Co-Investigator will retrospectively collect basic data of patients 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, gastrointestinal feeding tube placement, margin clearance, and remnant pancreatic volume on the occurrence of delayed gastric emptying and related quality of life. The goal is to understand and analyze risk factors, indications for feeding tube placement, management, and prognosis.

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:

  1. Males or females aged 20 years or older.
  2. Patients scheduled to undergo pancreatic surgery.

Exclusion Criteria:

  1. Patients under 20 years of age at this hospital.
  2. Presence of other active malignancies prior to diagnosis.
  3. Minors, pregnant women, breastfeeding women, and patients with psychiatric disorders.

Statistical Analysis Patient medical records will be utilized to analyze risk factors for delayed gastric emptying, indications for gastrointestinal feeding tube placement, management, and prognosis for patients undergoing pancreatic surgery, aiming to provide diverse and specific treatment recommendations in the future.

Confidentiality and Privacy Protection To ensure patient privacy and personal information security, after querying the relevant data of enrolled subjects, the data sheet will use new codes to represent the subjects' identities. Experimenters and analysts will only have access to this de-linked data sheet for analysis. All electronic data will be password-protected and accessible only by specific personnel related to this project.

All data not used or after analysis will be stored at the NTU Department of Surgery for 15 years and then destroyed by shredder or incineration to remove identifiable personal data, unless required for medical or research purposes. Researchers (including external personnel) will sign a written pledge stating that medical record data will not be reused, disclosed to third parties, or used for purposes outside this study, unless required by law or audited by the Research Ethics Committee.

Budget and Equipment Item Purpose Amount (TWD) Database Analysis Software Data Analysis 50,000 Statistical Consulting Data Analysis 50,000 Statistical Consulting Chart Creation 50,000 English Editing, Publication, Printing, Stationery Thesis Publication 50,000 Part-time Student

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

  • Males or females aged 20 years or older.
  • Patients scheduled to undergo pancreatic surgery.

排除标准

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

研究组 & 干预措施

pancreatectomy group

干预措施: pancreatectomy (Procedure)

结局指标

主要结局

Length of nasogastric tube intubation after surgery

时间窗: 3 months after poancreatetcomy

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

研究点 (1)

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