Accelerated recovery program for patients undergoing minimally invasive liver surgery
Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
This study is testing a new recovery program to see if it helps patients who have minimally invasive liver surgery leave the hospital sooner and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05879159 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of an accelerated recovery program designed to reduce the length of hospital stay for patients undergoing minimally invasive liver surgery. The program, known as ARAMIS Hep, integrates minimally invasive surgical techniques, enhanced recovery after surgery (ERAS) protocols, and Telehealth to safely liberalize discharge criteria. By focusing on lower complexity liver resections, the study will also gather data on patient experiences and recovery trajectories to inform broader implementation of this approach in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include adults with tumors suitable for minimally invasive Kawaguchi-Gayet grade I hepatectomy who do not have cirrhosis or significant cardiopulmonary disease.
Not a fit: Patients with tumors not amenable to minimally invasive surgical techniques or those with cirrhosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly shorten hospital stays and improve recovery experiences for patients undergoing liver surgery.
How similar studies have performed: Other studies have shown success with similar accelerated recovery approaches in surgical settings, indicating potential for this program's effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Hop Tran Cao, MD — M.D. Anderson Cancer Center
- Study coordinator: Hop Tran Cao, MD
- Email: hstran@mdanderson.org
- Phone: (713) 745-4670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.