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Evaluation of Resection Techniques for Pancreatic Tumors


2016-04-16


2025-04-26


2025-04-26


431

Study Overview

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.

  • Surgery
  • Liver Tumor
  • Pancreas Tumor
  • PROCEDURE: Resection techniques for pancreatic and liver tumors
  • 028.HPB.2016.D

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 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  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
Patient SurvivalIt 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 stayIt will be calculated in days. The days stayed in hospital post-procedure.Up to 1 year
Complication ratesPatient may visit physician or hospital for any symptoms or may need hospitalizations.through study completion, an average of 1 year
Operative timeThe time required for the procedure.up to 10 hours
Transfusion rateIf any post-procedure transfusion required, will be recorded.through study completion, an average of 1 year
30 and 90 day readmission rateAfter the procedure any hospital admissions up to 30 days will be recorded.through study completion, an average of 1 year
Hospital chargesThe hospital charges for the procedure will be recorded.through study completion, an average of 1 year
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Patients that have undergone pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)
  • Patients 18 years old or older

  • Exclusion Criteria:

  • Patients that have not undergone pancreatic resection surgeries
  • Patients under 18 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Alejandro Mejia, M.D., The Liver Institute, Methodist Dallas Medical Center

    Publications

    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