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

NCT ID: NCT05879159

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2027-02-01

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.

Conditions

Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Accelerated Recovery Protocol

Accelerated Recovery after Minimally Invasive Hepatic Surgery (ARAMIS-Hep)

Participants randomized to this arm will undergo a recovery pathway that potentially allows for discharge on the day of surgery (post-operative day 0).

• You will receive a clear liquid diet, be encouraged to ambulate independently, and opioid use will be minimized in the recovery unit.
• You will be assessed in the post-operative recovery unit. If you meet discharge criteria, you will be discharged the afternoon/evening of surgery. If you do not, you will be admitted for overnight observation.
• You will have a telehealth video visit on post-operative days 1 and 2
• You will have in-person clinic visit within 14 days of discharge.

You will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery

Group Type: EXPERIMENTAL

Questionnaires

Intervention Type: BEHAVIORAL

Survey

Comparison/Control Arm

Standard Post-operative recovery pathway after minimally invasive hepatic surgery.

Participants randomized to this arm will undergo our institution's standard recovery pathway for minimally invasive liver surgery.

• You will be transferred to the Transitional PACU for overnight observation.
• Your diet will be advanced to gastrointestinal "first food" diet on Post-operative Day 1, with opioid weaning and frequent ambulation.
• You will be discharged once criteria are met.
• You will have an in-person clinic visit within 14 days of discharge.

You will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery.

Group Type: EXPERIMENTAL

Questionnaires

Intervention Type: BEHAVIORAL

Survey

Interventions

Questionnaires

Survey

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intuitive Surgical Inc

UNKNOWN

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hop Tran Cao, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hop Tran Cao, MD

Role: CONTACT

hstran@mdanderson.org

(713) 745-4670

Facility Contacts

Hop Tran Cao, MD

Role: primary

hstran@mdanderson.org

713-745-4670

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2023-04169

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0917

Identifier Type: -

Identifier Source: org_study_id