Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection

Liver Clinical Trial

Official title:

Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879159
• Other study ID #: 2022-0917
• Secondary ID: NCI-2023-04169
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Hop Tran Cao, MD
• Phone: (713) 745-4670
• Email: hstran[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.

Description:

Primary Objectives:

Our study will investigate the feasibility of an accelerated recovery program to minimize length of stay (LOS) and facilitate outpatient surgery for patients undergoing minimally invasive, lower complexity (Kawaguchi-Gayet grade I) liver resection. This program (ARAMIS Hep) will combine minimally invasive surgical (MIS) approaches (robotic OR laparoscopic), enhanced recovery after surgery (ERAS) protocols, and Telehealth to liberalize discharge criteria in a safe manner.

Secondary Objectives:

In addition to demonstrating a reduction in LOS, our study will also provide preliminary data to aid in the broader implementation of this approach. Specifically, we will gain insight into the patient experience, measure patient-reported outcomes on recovery trajectories, and understand barriers to integrating a novel pathway into existing institutional frameworks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tumor amenable to MIS Kawaguchi-Gayet grade I hepatectomy (see figure 1 below)

• No evidence of cirrhosis (based on imaging, evidence of portal hypertension, clinical features, or laboratory results)

• No significant cardiopulmonary disease that would prevent patients from undergoing MIS resection

• Ability to stay within 50 miles of medical center for immediate postop period

• Age of 18 years or above - because no adverse event data are currently available on enhanced recovery and early discharge after hepatic resection for patients <18 years of age, children are excluded from this study

• Ability to understand and the willingness to sign a written informed consent document

• Non-English-speaking patients are eligible for participation

Exclusion Criteria:

Patients who will be excluded include those with:

• Tumors NOT amenable to MIS Kawaguchi-Gayet grade I hepatectomy

• Tumors not amenable to MIS or Robotic-assisted surgical resection

• Evidence of Cirrhosis on imaging, clinically, or lab testing

• Inability to stay within 50 miles of the Cancer Center in the immediate post-operative period

• Age below 18 years

• Inability to consent for trial/protocol

• Patients who are pregnant

Related Conditions & MeSH terms

• Liver

Intervention

Behavioral:
• Questionnaires
Survey

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Intuitive Surgical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0		through study completion; an average of 1 year.

External Links

•   M D Anderson Cancer Center