Clinical trial NCT05879159: Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
Official title: Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical Inc
First posted: 2023-05-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Hop Tran Cao, MD
role: PRINCIPAL_INVESTIGATOR
References: