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

NCT05879159 | Recruiting

• 2 other identifiers: 2022-0917NCI-2023-04169
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  through study completion; an average of 1 year.

Study Arms (2)

Accelerated Recovery Protocol

EXPERIMENTAL

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

Comparison/Control Arm

EXPERIMENTAL

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

Questionnaires BEHAVIORAL

Survey

Accelerated Recovery Protocol; Comparison/Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Intuitive Surgical Inc: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hop Tran Cao, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hop Tran Cao, MD

CONTACT

(713) 745-4670; hstran@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: October 5, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)