- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07382791
Delayed Gastric Emptying After Pancreatic Surgery
The Analysis of Delayed Gastric Emptying After Pancreatic Surgery
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:
- Males or females aged 20 years or older.
- Patients scheduled to undergo pancreatic surgery.
Exclusion Criteria:
- 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.
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
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yu Wen Tien, Ph.D.
- Phone Number: 0972651427
- Email: ywtien5106@ntu.edu.tw
Study Locations
-
-
Taiwn
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Taipei, Taiwn, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Yu Wen Tien, Ph.D.
- Phone Number: 0972651427
- Email: ywtien5106@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males or females aged 20 years or older.
- Patients scheduled to undergo pancreatic surgery.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
pancreatectomy group
|
All procedures demanding pancreatic parenchyma transaction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of nasogastric tube intubation after surgery
Time Frame: 3 months after poancreatetcomy
|
3 months after poancreatetcomy
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Paralysis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pancreatic Neoplasms
- Gastroparesis
- Surgical Procedures, Operative
- Digestive System Surgical Procedures
- Pancreatectomy
Other Study ID Numbers
- 20217135RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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