- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05879159
Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hop Tran Cao, MD
- Phone Number: (713) 745-4670
- Email: hstran@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Hop Tran Cao, MD
- Phone Number: 713-745-4670
- Email: hstran@mdanderson.org
-
Principal Investigator:
- Hop Tran Cao, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery |
Survey
|
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 fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery. |
Survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
through study completion; an average of 1 year.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hop Tran Cao, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-0917
- NCI-2023-04169 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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