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2016-04-16
2025-04-26
2025-04-26
431
NCT05128890
Methodist Health System
Methodist Health System
OBSERVATIONAL
Evaluation of Resection Techniques for Pancreatic Tumors
The objective of this study is to compare open and minimally invasive pancreatic and liver resection techniques and analyze the different outcome variables from the clinical standpoint. The plan is to investigate patient survival, length of stay, complication rates, operative time, transfusion rate, 30 and 90-day readmission rate, and hospital charges.
The plan is to conduct a retrospective chart review of patients who have undergone pancreatic and liver resection by using Meditech and Epic. A non-identified database will be created after retrospectively reviewing each patient case involving pancreatic or liver resection at MDMC. The study period will start in January 2006 until December 2020. Variables will include demographics, clinical disease diagnoses, and operative parameters as well as indirect charges from the hospitalizations.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-08-12 | N/A | 2024-03-26 |
2021-11-09 | N/A | 2024-03-28 |
2021-11-22 | N/A | 2024-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Patient Survival | It will be calculated in days.Minimally invasive techniques are being adopted for complex pancreatic and liver surgery and there is a need to understand if these techniques are advantageous to the patient, if the cost is justified and if the risks are acceptable when compared to the gold standard open surgery. | through study completion, an average of 1 year |
| Length of stay | It will be calculated in days. The days stayed in hospital post-procedure. | Up to 1 year |
| Complication rates | Patient may visit physician or hospital for any symptoms or may need hospitalizations. | through study completion, an average of 1 year |
| Operative time | The time required for the procedure. | up to 10 hours |
| Transfusion rate | If any post-procedure transfusion required, will be recorded. | through study completion, an average of 1 year |
| 30 and 90 day readmission rate | After the procedure any hospital admissions up to 30 days will be recorded. | through study completion, an average of 1 year |
| Hospital charges | The hospital charges for the procedure will be recorded. | through study completion, an average of 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Colette N Ndjom, MS Phone Number: 214-947-4681 Email: ClinicalResearch@mhd.com |
Study Contact Backup Name: Loretta W Bedell, MPH Phone Number: 214 947 4680 Email: MHSIRB@MHD.COM |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
