Accelerated Recovery Program for Liver Surgery

Overseen By Hop Tran Cao, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cirrhosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special recovery plan can help patients leave the hospital sooner after liver surgery. Participants will follow various recovery methods, with one group possibly going home the same day as the surgery. The trial requires participants to complete 14 questionnaires over a month to track their recovery experiences. It is suitable for those with a specific type of liver tumor that can be treated with minimally invasive surgery and who can remain nearby the hospital after surgery. As an unphased trial, it offers a unique opportunity to contribute to innovative recovery strategies and potentially benefit from cutting-edge care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this accelerated recovery protocol is safe for liver surgery patients?

Research has shown that enhanced recovery programs, like the one under study, are generally safe and well-tolerated. These programs can reduce hospital stays and improve recovery for liver surgery patients by encouraging early movement, minimizing painkiller use, and promoting a quicker return to normal eating.

One study found that following the program's steps significantly shortened hospital stays. Another study noted that patients who adhered to these steps experienced better short-term outcomes, such as fewer post-surgery complications.

Overall, the safety data for these programs is promising. They have been successfully used in similar surgeries, suggesting they are safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Accelerated Recovery Program for liver surgery because it aims to significantly reduce recovery time compared to standard post-operative care. This innovative protocol allows some patients to potentially be discharged on the same day as their minimally invasive surgery, thanks to a focused recovery plan that includes a clear liquid diet, encouragement of independent movement, and minimized opioid use. By integrating telehealth follow-ups and efficient discharge procedures, this approach could enhance patient convenience and reduce hospital stays, which are big wins for both patients and healthcare systems.

What evidence suggests that this trial's treatments could be effective for accelerated recovery after liver surgery?

Research has shown that the Accelerated Recovery Program, also known as Enhanced Recovery After Surgery (ERAS), offers significant benefits for liver surgery patients. In this trial, participants in the Accelerated Recovery Protocol arm will follow a recovery pathway that may allow discharge on the day of surgery. Studies have found that these protocols help patients leave the hospital sooner and recover more quickly. Patients in this program often experience less pain and require fewer painkillers. Additionally, these programs are associated with fewer post-surgery complications. Overall, evidence suggests that an accelerated recovery program can help patients recover faster and more comfortably after minimally invasive liver surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Hop Tran Cao, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 without cirrhosis who have a liver tumor that can be removed with minimally invasive surgery. Participants must not have serious heart or lung conditions, should stay close to the medical center post-surgery, and must understand and sign consent.

Inclusion Criteria

My liver tumor can be removed with a minimally invasive surgery.

Ability to understand and the willingness to sign a written informed consent document

I don't have serious heart or lung conditions that would stop me from having minimally invasive surgery.

Exclusion Criteria

I have been diagnosed with cirrhosis.

Pregnant patients

My tumor cannot be removed with minimally invasive surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive liver resection with an accelerated recovery protocol or standard recovery pathway

1 day

In-person surgery and post-operative assessment

Post-operative Monitoring

Participants are monitored post-surgery with telehealth visits on post-operative days 1 and 2, and an in-person clinic visit within 14 days of discharge

14 days

2 telehealth visits, 1 in-person visit

Follow-up

Participants complete questionnaires over a 30-day period to assess recovery

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Questionnaires

Trial Overview The study tests whether an accelerated recovery program helps patients leave the hospital sooner after minimally invasive liver surgery. It involves following specific procedures and completing questionnaires.

How Is the Trial Designed?

Group I: Comparison/Control Arm Experimental Treatment 1 Intervention

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.

Group II: Accelerated Recovery Protocol Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Intuitive Surgical Inc

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

Enhanced recovery protocols may lead to a shorter hospital stay and reduced costs for patients undergoing major upper gastrointestinal, liver, and pancreatic surgeries, based on a review of 10 studies involving 1014 participants.

Despite these potential benefits, the overall quality of evidence is low, and the trials showed a high risk of bias, indicating that further research is needed to confirm these findings and assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery protocols for major upper gastrointestinal, liver and pancreatic surgery. Bond-Smith, G., Belgaumkar, AP., Davidson, BR., et al.[2022]

A modified fast-track program for liver resection, involving early mobilization and high-dose methylprednisolone, resulted in a median hospital stay of just 4 days, demonstrating its efficacy in hastening recovery.

The program was safe, with a 6% readmission rate and zero 30-day mortality, indicating that early discharge after major liver surgery is feasible and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second Generation of a Fast-track Liver Resection Programme. Schultz, NA., Larsen, PN., Klarskov, B., et al.[2018]

In a study of 64 patients undergoing liver resections in a fast-track program, the median hospital length of stay (LOS) was significantly reduced to 6 days compared to 8 days in a historical cohort of 62 patients, indicating improved recovery protocols.

Factors that prolonged LOS in the fast-track group included the presence of complications, the extent of liver resection, and the ability to drink more than 1250 ml of fluid the day after surgery, highlighting the need for targeted support for patients with limited fluid intake post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast-track program for liver resection--factors prolonging length of stay. Blind, PJ., Andersson, B., Tingstedt, B., et al.[2015]

The enhanced recovery after surgery (ERAS) program significantly improved postoperative recovery in liver transplant patients, leading to lower rates of complications such as ventilator-associated pneumonia and urinary tract infections, while also enhancing quality of life as indicated by higher Barthel scores.

Patients in the ERAS group experienced shorter stays in the intensive care unit and overall hospital, as well as reduced medical expenses, demonstrating the program's effectiveness in both clinical outcomes and cost savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of enhanced recovery after surgery following liver transplantation. Jin, B., Gu, Y., Xi, S., et al.[2023]

The study involved 336 patients undergoing liver surgery, with 170 in the enhanced recovery after surgery (ERAS) group and 166 in the control group, showing that ERAS significantly improved preoperative nutrition support and reduced postoperative discomfort.

Patients in the ERAS group experienced faster recovery, including earlier feeding, less pain, and shorter hospital stays, indicating that ERAS is a safe and effective approach for enhancing recovery after liver surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Practice and application of enhanced recovery after surgery in perioperative period of liver operation]. Gu, LL., Zhang, XJ., Li, J., et al.[2019]

Enhanced recovery protocols (ERPs) in hepatic resection led to earlier oral intake and return of bowel function without increasing overall morbidity or mortality, demonstrating their safety and efficacy.

Patients undergoing ERP had a significantly shorter hospital length of stay, with 43% discharged within 4 days compared to 27% in the pre-ERP group, indicating improved recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of an Enhanced Recovery Protocol After Hepatic Resection. Lee, JA., Young, S., O'Connor, V., et al.[2021]

Liver resection surgery significantly impacts physical health more than mental health, as shown by a decrease in the physical component summary (PCS) of the SF-36 from baseline to postoperative day 7.

Preoperative physical health, measured by PCS, can predict postoperative complications, with patients experiencing complications showing significantly lower baseline PCS scores compared to those without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of physical and mental recovery status after elective liver resection. Arnberger, M., Vogt, A., Studer, P., et al.[2014]

Implementing a flexible enhanced recovery after surgery (ERAS) program for 168 patients undergoing partial hepatectomy led to a median hospital discharge of 6 days, with earlier discharges associated with fewer complications.

Patients who had early removal of tubes and started oral feeding sooner experienced a statistically significant reduction in hospital stay, demonstrating that a tailored approach to ERAS can improve recovery without increasing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonstrict and individual enhanced recovery after surgery (ERAS) in partial hepatectomy. Xu, X., Wang, Y., Feng, T., et al.[2020]

Implementing an enhanced recovery pathway in liver surgery can lead to better patient outcomes, including improved patient-reported experiences and shorter hospital stays.

This approach not only facilitates a quicker return to oncology treatments but also helps reduce overall healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery in liver surgery. Day, RW., Aloia, TA.[2019]

The enhanced recovery programme significantly reduced the median length of hospital stay for patients undergoing liver surgery for colorectal metastases, with an average of 7 days compared to 8 days for standard care.

Despite the improved hospital stay, the enhanced recovery programme did not show any significant impact on long-term survival rates at one, three, or five years post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the enhanced recovery programme on long-term survival following liver resection for colorectal liver metastases. Lambert, J., Mair, T., Arujunan, K., et al.[2023]

The implementation of the Enhanced Recovery After Surgery (ERAS) program in 1143 patients undergoing hepatectomy significantly improved disease-free survival (DFS) and overall survival (OS) rates, with 1-year DFS at 96.3% and OS at 93.1% compared to lower rates in the non-ERAS group.

Patients in the ERAS group experienced fewer postoperative complications, including lower rates of hemorrhage and deep vein thrombosis, as well as shorter hospital stays, indicating that the ERAS program enhances recovery and safety after liver surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Enhanced Recovery After Surgery on Long-Term Outcomes and Postoperative Recovery in Patients Undergoing Hepatectomy: A Retrospective Cohort Study. Zhang, Z., Gu, W., Zhang, Y.[2022]

A study involving 154 patients who underwent colorectal surgery as part of an Enhanced Recovery After Surgery (ERAS) program found that longer surgical procedures and cancer diagnoses were linked to higher rates of hospital readmission within 6 months post-surgery.

Patients who had open surgeries reported significantly higher pain scores at the 6-month mark compared to those who had laparoscopic procedures, indicating that the type of surgical approach can impact long-term pain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes 6 months after enhanced recovery after colorectal surgery. Deiss, T., Chen, LL., Sarin, A., et al.[2022]

Enhanced recovery after surgery programs (ERPs) significantly improved functional recovery and reduced complications in patients undergoing open liver resection, with a comparable length of hospital stay of 7 days for both ERP and historical cohorts.

In laparoscopic liver resection, ERPs did not show significant differences in recovery outcomes except for a lower readmission rate, indicating that the benefits of ERPs are more pronounced in open surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of enhanced recovery on open and laparoscopic liver resections. Giovinazzo, F., Kuemmerli, C., Moekotte, A., et al.[2020]

Citations

1. trialx.com trialx.com/clinical-trials/listings/249398/accelerated-recovery-after-mis-hepatectomy-aramis-hep-to-support-early-discharge-for-patients-undergoing-minimally-invasive-liver-resection/

Accelerated Recovery After MIS Hepatectomy (ARAMIS ... Our study will investigate the feasibility of an accelerated recovery program to minimize length of stay (LOS) and facilitate outpatient surgery ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11341879/

Feasibility, safety and effectiveness of the enhanced recovery ... Our study highlights the significant benefits of implementing an ERAS protocol for major hepatic resections. By closely adhering to the various components of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1365182X25006380

Finetuning and optimizing an enhanced recovery protocol ... Conclusion. The implementation of an optimized CP in liver surgery resulted in a shorter hospital stay and higher adherence rate to the ERAS-protocol.

4. withpower.com withpower.com/trial/phase-liver-9-2023-9a290

Accelerated Recovery Program for Liver Surgery The Accelerated Recovery Program, also known as Enhanced Recovery After Surgery (ERAS), has been shown to be safe for liver surgery patients.

5. jogs.org jogs.org/article/S1091-255X(23)02606-9/abstract

Enhanced Recovery after Surgery Programs for Liver ... The meta-analysis demonstrated that enhanced recovery after surgery programs could reduce morbidity, hospital stays and cost, blood loss, and time to bowel ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210740124002146

Safety and efficacy of the enhanced recovery after surgery ... The aim of this research was to evaluate the efficacy and safety of enhanced recovery after surgery (ERAS) protocol in hepatectomy patients with liver cancer.

7. wjgnet.com wjgnet.com/1948-9366/full/v17/i7/107085.htm

Efficacy and safety of enhanced recovery after surgery ... The current meta-analysis indicated that ERAS protocols can significantly improve short-term clinical outcomes in liver transplant recipients, ...