LiverNCT05879159
Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
A study testing Questionnaires in people with Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Liver
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Survey
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start5 Oct 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiverStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Sponsor
- Investigators
- Hop Tran Cao, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879159
- Sponsor's protocol ID
- 2022-0917
- Other IDs
- NCI-2023-04169
- Status last verified
- Oct 2026
- First submitted
- 18 May 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
- ClinicalTrials.gov ID
- NCT05879159
- Acronym / sponsor ID
- 2022-0917
- Conditions
- Liver
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated Recovery Protocol | Experimental | Behavioral: QuestionnairesAccelerated 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 |
| Comparison/Control Arm | Experimental | Behavioral: QuestionnairesStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesSurvey | Behavioural | Accelerated Recovery Protocol, Comparison/Control Arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hop Tran Cao, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.