Recruiting

ARAMIS Hep

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05879159

Conditions

Liver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Study Details

Brief summary:

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

Conditions

Liver

Study ID

NCT05879159

Start date

Oct 5, 2023

Status verified date

Apr, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

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.

Interventions

Questionnaires

Survey

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Hop Tran Cao, MD

(713) 745-4670hstran@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Hop Tran Cao, MD

713-745-4670hstran@mdanderson.org

Principal Investigator:

Hop Tran Cao, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.