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NCT Number: NCT05879159

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

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Hop Tran Cao, MD

CONTACT

[email protected]

713-745-4670

Hop Tran Cao, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Behavioral

Survey

Primary outcomes

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Time frame: through study completion; an average of 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Hop Tran Cao, MD

CONTACT

[email protected]

(713) 745-4670

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Intuitive Surgical

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 30, 2023
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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