Evaluation of Resection Techniques for Pancreatic Tumors

March 26, 2024 updated by: Methodist Health System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

431

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

Study Contact Backup

  • Name: Loretta W Bedell, MPH
  • Phone Number: 74680 214 947 4680
  • Email: MHSIRB@MHD.COM

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Methodist Dallas Medical Center
        • Contact:
          • Colette N Ndjom, MS
          • Phone Number: 71280 214-947-4681
          • Email: mhsirb@mhd.com
        • Contact:
          • Loretta W Bedell, MPH
          • Phone Number: 74680 217-947-4680
          • Email: mhsirb@mhd.com
        • Principal Investigator:
          • Alejandro Mejia, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)

Description

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

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Survival
Time Frame: through study completion, an average of 1 year
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
Time Frame: Up to 1 year
It will be calculated in days. The days stayed in hospital post-procedure.
Up to 1 year
Complication rates
Time Frame: through study completion, an average of 1 year
Patient may visit physician or hospital for any symptoms or may need hospitalizations.
through study completion, an average of 1 year
Operative time
Time Frame: up to 10 hours
The time required for the procedure.
up to 10 hours
Transfusion rate
Time Frame: through study completion, an average of 1 year
If any post-procedure transfusion required, will be recorded.
through study completion, an average of 1 year
30 and 90 day readmission rate
Time Frame: through study completion, an average of 1 year
After the procedure any hospital admissions up to 30 days will be recorded.
through study completion, an average of 1 year
Hospital charges
Time Frame: through study completion, an average of 1 year
The hospital charges for the procedure will be recorded.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Methodist Health System

Investigators

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

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)

April 16, 2016

Primary Completion (Estimated)

April 26, 2025

Study Completion (Estimated)

April 26, 2025

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 028.HPB.2016.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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