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

Not Applicable

Recruiting

• Conditions: Liver

• Registration Number: NCT05879159
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-30
• Study Start: 2023-10-05
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States