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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05879159
Enrollment
36
Registered
2023-05-30
Start date
2023-10-05
Completion date
2027-02-01
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver

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.

Interventions

BEHAVIORALQuestionnaires

Survey

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
Intuitive Surgical Inc
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTHop Tran Cao, MD
hstran@mdanderson.org(713) 745-4670
PRINCIPAL_INVESTIGATORHop Tran Cao, MD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026