CClinicalTrials.gg
RecruitingNCT05879159Updated Apr 15, 2026

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

An interventional study of Questionnaires in Liver, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Liver
03

In context

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    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

    Behavioral: Questionnaires

  • Experimental
    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.

    Behavioral: Questionnaires

Interventions

  • BehavioralQuestionnaires

    Survey

06

What researchers measure

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.

07

Study locations

1 of 1 sites recruiting
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
    • Hop Tran Cao, MD · Contact · hstran@mdanderson.org · 713-745-4670
    • Hop Tran Cao, MD · Principal investigator
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05879159
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
Intuitive Surgical
Responsible party
Sponsor
First posted
May 30, 2023
Start date
Oct 5, 2023
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Apr 15, 2026

Study contacts

Hop Tran Cao, MD
Contact
hstran@mdanderson.org
(713) 745-4670
Hop Tran Cao, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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