Longitudinal Outcomes in Hepatic Resection

Surgery Clinical Trial

Official title:

Longitudinal Outcomes in Hepatic Resection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02997098
• Other study ID #: Pro00078618
• Status: Withdrawn
• Start date: May 4, 2017
• Est. completion date: May 2037

Study information

• Verified date: July 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This observational registry of patients undergoing liver surgery collects patients both retrospectively and prospectively. Patients undergoing liver resection for any non-transplant indication will be evaluated for clinical outcomes (such as surgical complications, survival, and disease progression) based on clinical and patient factors (like indication, age, and other treatments for the disease).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2037
• Est. primary completion date: May 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring liver resection

Exclusion Criteria:

• Patients under the age of 18 years

• Patients undergoing liver transplant

Related Conditions & MeSH terms

• Liver Diseases
• Surgery

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		10 years
Secondary	Disease-free survival		10 years
Secondary	Surgical-site infection		3 months
Secondary	Postoperative bleeding		3 months
Secondary	Blood clot		3 months
Secondary	Use of other therapy	e.g., antibiotics in liver abscess, chemotherapy in liver cancer	5 years
Secondary	Operative time		1 day
Secondary	Intraoperative blood loss		1 day
Secondary	Number of segments resected	If applicable	1 day