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Accelerated Recovery Program for Liver Surgery
N/A
Recruiting
Led By Hop Tran Cao, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial tests if a program can reduce hospital stay for those having liver surgery by speeding up their recovery.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on recovery methods rather than medication, side effects are not typical as in drug trials. However, participants may experience discomfort from standard surgical risks or from completing questionnaires.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Investigations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Infections and infestations
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Immune system disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Comparison/Control ArmExperimental Treatment1 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 ProtocolExperimental Treatment1 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,440 Total Patients Enrolled
Intuitive Surgical IncUNKNOWN
Hop Tran Cao, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cirrhosis.My tumor cannot be removed with minimally invasive surgery.I am unable to give consent for the trial.My liver tumor cannot be removed with a minimally invasive surgery.I am under 18 years old.My liver tumor can be removed with a minimally invasive surgery.I do not speak English but can join the study.My liver does not show signs of cirrhosis or portal hypertension.I don't have serious heart or lung conditions that would stop me from having minimally invasive surgery.I can stay within 50 miles of the hospital after surgery.I am 18 years old or older.I cannot stay near the Cancer Center after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Accelerated Recovery Protocol
- Group 2: Comparison/Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment currently underway for this investigation?
"The clinical trial registry hosted on clinicialtrials.gov reports that this particular medical study is no longer enrolling patients, as the last time it was edited was May 26th 2023. Thankfully, there are two alternative trials currently accepting participants."
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