Evaluation of Resection Techniques for Pancreatic Tumors

Surgery Clinical Trial

Official title:

Evaluation of Resection Techniques for Pancreatic Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05128890
• Other study ID #: 028.HPB.2016.D
• Status: Recruiting
• Start date: April 16, 2016
• Est. completion date: April 26, 2025

Study information

• Verified date: February 2024
• Source: Methodist Health System
• Contact: Colette N Ndjom, MS
• Phone: 214-947-4681
• Email: ClinicalResearch[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 431
• Est. completion date: April 26, 2025
• Est. primary completion date: April 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Tumor
• Neoplasms
• Pancreas Tumor
• Pancreatic Neoplasms
• Surgery

Intervention

Procedure:
• Resection techniques for pancreatic and liver tumors
to compare open versus minimally invasive pancreatic resection techniques and analyze the different outcome variables from the clinical standpoint

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

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