Evaluation of Resection Techniques for Pancreatic Tumors

Recruiting

• Conditions: Surgery; Pancreas Tumor; Liver Tumor

• Registration Number: NCT05128890
• Lead Sponsor: Methodist Health System

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.

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 Timeline

• Study Start: 2016-04-16
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-04-26
• Study Completion: 2025-04-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 431

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transfusion rate	through study completion, an average of 1 year	If any post-procedure transfusion required, will be recorded.
Operative time	up to 10 hours	The time required for the procedure.
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.
Length of stay	Up to 1 year	It will be calculated in days. The days stayed in hospital post-procedure.
Complication rates	through study completion, an average of 1 year	Patient may visit physician or hospital for any symptoms or may need hospitalizations.
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.
Hospital charges	through study completion, an average of 1 year	The hospital charges for the procedure will be recorded.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States