Delayed Gastric Emptying After Pancreatic Surgery
报名条件(概要)
- 年龄:20 Years – 75 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
Taiwan
研究药物 / 干预措施
pancreatectomy
申办方
National Taiwan University Hospital
研究简介(原文)
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
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Yu Wen Tien, Ph.D.ywtien5106@ntu.edu.tw0972651427
中国/港澳台研究中心
- National Taiwan University HospitalTaipei,Taiwn,Taiwan
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Delayed Gastric Emptying After Pancreatic Surgery ClinicalTrials.gov Identifier: NCT07382791 Sponsor: National Taiwan University Hospital Investigational product: pancreatectomy About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Delayed Gastric Emptying After Pancreatic Surgery 试验编号:NCT07382791 申办方:National Taiwan University Hospital 研究药物:pancreatectomy 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。