Evaluation of Resection Techniques for Pancreatic Tumors

Sponsor
Methodist Health System (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05128890
Collaborator
(none)
250
83.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Resection techniques for pancreatic and liver tumors

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 October 31, 2017. Variables will include demographics, clinical disease diagnoses, and operative parameters as well as indirect charges from the hospitalizations.

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Evaluation of Resection Techniques for Pancreatic Tumors
Actual Study Start Date :
May 26, 2016
Anticipated Primary Completion Date :
May 25, 2023
Anticipated Study Completion Date :
May 25, 2023

Outcome Measures

Primary Outcome Measures

  1. Patient Survival [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.

  2. Length of stay [Up to 1 year]

    It will be calculated in days. The days stayed in hospital post-procedure.

  3. Complication rates [through study completion, an average of 1 year]

    Patient may visit physician or hospital for any symptoms or may need hospitalizations.

  4. Operative time [up to 10 hours]

    The time required for the procedure.

  5. Transfusion rate [through study completion, an average of 1 year]

    If any post-procedure transfusion required, will be recorded.

  6. 30 and 90 day readmission rate [through study completion, an average of 1 year]

    After the procedure any hospital admissions up to 30 days will be recorded.

  7. Hospital charges [through study completion, an average of 1 year]

    The hospital charges for the procedure will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • • Patients that have undergone pancreatic or liver resection surgeries from January 2006 until October 31, 2017 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Methodist Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT05128890
Other Study ID Numbers:
  • 028.HPB.2016.D
First Posted:
Nov 22, 2021
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022