- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05014425
Risk Factors for Post Whipple Pancreatic Fistula
August 14, 2021 updated by: Ramy A. Hassan, Assiut University
Risk Factors Predicting Development of Pancreatic Fistula Following Pancreaticoduodenectomy
Postoperative pancreatic fistula (POPF) following pancreaticoduodenectomy is considered a life-threatening complication.
This study was designed to analyze the risk factors for development of such fistula in a tertiary care center (Al-Rajhi Liver Hospital/ Assiut University).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
96
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients underwent pancreaticoduodenectomy at Al-Rajhi liver Hospital, Assiut university from January 2017 to December 2020
Description
Inclusion Criteria:
- All patients underwent pancreaticoduodenectomy for pancreatic cancer
Exclusion Criteria:
- All types of pancreatic resection other than pancreaticoduodenectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of pancreatic fistula following pancreaticoduodenectomy
Time Frame: Baseline
|
Analysis of risk factors for development of pancreatic fistula following pancreaticoduodenectomy
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
December 31, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
August 14, 2021
First Submitted That Met QC Criteria
August 14, 2021
First Posted (ACTUAL)
August 20, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 20, 2021
Last Update Submitted That Met QC Criteria
August 14, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pancreatic fistula
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.