Living Donor HepatectomyNCT04079673
Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota
A study of Living Donor Hepatectomy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
As the only curative treatment for end-stage liver diseases, liver transplantation has been widely carried out around the world. The shortage of organs from deceased donors facilitate the adoption of living donor liver transplantation. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Living Donor Hepatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Oct 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Expected to receive living liver hepatectomy in National Taiwan University Hospital, age between 20 and 55 years old.
Who cannot join
- Previous use of antibiotics within four weeks.
- Previous gastrointestinal surgery.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, National Taiwan University Hospital
Taipei, 100
About this study
Official title: The Effect of Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota and Gastrointestinal Function Recovery in Living Donor Hepatectomy
As the only curative treatment for end-stage liver diseases, liver transplantation has been widely carried out around the world. The shortage of organs from deceased donors facilitate the adoption of living donor liver transplantation. Living donor hepatectomy is the most massive operation a healthy person could undergo, so donor safety is of utmost importance. However, previous studies focused on the outcomes of liver transplant recipients. There are still many uncertainties about the recovery in living liver donors.
The body microorganisms that reside in the human intestinal tract, referred to as the gut microbiota, are essential to human metabolism and immunity. The physiological functions of microbiota include defense against pathogens, providing nutrients such as vitamin B12 folate and vitamin K, and modulating gut integrity and permeability. Despite relatively stable microbiota during life, different illnesses, surgeries, medications dietary factors, and lifestyle changes could contribute to the imbalance of ecosystems resulting many gastrointestinal and extra-gastrointestinal disorders. Many researches have established a relationship between the gut microbiome and patients with liver disease such as liver cirrhosis, alcoholic liver disease and obesity related liver diseases etc. These liver disorders are associated with bacterial overgrowth, dysbiosis, and increased intestinal permeability. However, the relationship between hepatectomy and microbiota has not been fully investigated, especially in healthy liver donors.
Many routine perioperative management can impact the state of the microbiome and therefore can impact clinical outcomes, like bowel preparation and antibiotics. Potential factors affecting the gut microbiota also include perioperative manipulation, stress released hormones, and opioids. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including volatile anesthetics and opioids, is associated with altered gut microbiota. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages. Epidural analgesia has been proved to improve gastrointestinal function in major abdominal and thoracic surgery. However, the effect of perioperative epidural anesthesia and analgesia on microbiota is not clear.
- Conditions
- Living Donor Hepatectomy
- Being tested
- Patient controlled epidural analgesia, Intravenous patient controlled analgesia
- Keywords
- epidural anesthesia, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient controlled epidural analgesiaProcedure or surgery
Also called PCEA
Patient controlled epidural analgesia with marcaine 0.66mg/ml +fentanyl 1.75mcg/ml for postoperative pain control
Intravenous patient controlled analgesiaDrug
Also called IVPCA
Intravenous patient controlled analgesia with morphine 1mg/ml for postoperative pain control
| Study group | Role | What they receive |
|---|---|---|
| Patient controlled epidural analgesia | Active comparator | Use of patient controlled epidural analgesia (PCEA) for postoperative pain control Receives: Procedure: Patient controlled epidural analgesia |
| Intravenous patient controlled analgesia | Sham comparator | Use of intravenous patient controlled analgesia(IVPCA) for postoperative pain control Receives: Drug: Intravenous patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota analysis
16S metagenomic sequence processing
Measured: one month
Secondary outcomes (5)
LPS-binding protein
LPS-binding protein(mcg/mL)
Measured: one month
Intestinal fatty acid binding protein
Intestinal fatty acid binding protein(ng/mL)
Measured: one month
IgA
IgA(mcg/mL)
Measured: one month
IL-6
IL-6(ng/mL)
Measured: one month
I-FEED scoring
I-FEED scoring system for postoperative gastrointestinal function:
- Intake(score): tolerating oral diet(0), limited tolerance(1), complete Intolerance(3)
- Feeling nauseated(score): none(0), responsive to treatment(1), resistant to treatment(3)
- Emesis(score): none(0), ≧1 episode of low volume(<100mL) and none bilious(1), ≧1 episode of high volume(>100mL) or bilious(3)
- Exam(score): no distension(0), distension without tympany(1), significant distension with tympany(3)
- Duration of symptoms(score):0-24hours(0),24-72hours(1),>72hours(2)
Total score: 0-2 normal, 3-5 postoperative GI intolerance, >6 postoperative GI dysfunction
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start19 Oct 2019
- Primary completion25 Sep 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor HepatectomyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-Cheng Chan, M.D.,PhD, Principal investigator, Department of Anesthesiology, Natioanal Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079673
- Sponsor's protocol ID
- 201812090RINC
- Status last verified
- May 2026
- First submitted
- 3 Sep 2019
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Epidural Anesthesia and Analgesia on Gut Microbiota and Gastrointestinal Function Recovery in Living Donor Hepatectomy
- ClinicalTrials.gov ID
- NCT04079673
- Acronym / sponsor ID
- 201812090RINC
- Conditions
- Living Donor Hepatectomy
- Keywords
- epidural anesthesia, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 6 Sep 2019 (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.
As the only curative treatment for end-stage liver diseases, liver transplantation has been widely carried out around the world. The shortage of organs from deceased donors facilitate the adoption of living donor liver transplantation. Living donor hepatectomy is the most massive operation a healthy person could undergo, so donor safety is of utmost importance. However, previous studies focused on the outcomes of liver transplant recipients. There are still many uncertainties about the recovery in living liver donors.
The body microorganisms that reside in the human intestinal tract, referred to as the gut microbiota, are essential to human metabolism and immunity. The physiological functions of microbiota include defense against pathogens, providing nutrients such as vitamin B12 folate and vitamin K, and modulating gut integrity and permeability. Despite relatively stable microbiota during life, different illnesses, surgeries, medications dietary factors, and lifestyle changes could contribute to the imbalance of ecosystems resulting many gastrointestinal and extra-gastrointestinal disorders. Many researches have established a relationship between the gut microbiome and patients with liver disease such as liver cirrhosis, alcoholic liver disease and obesity related liver diseases etc. These liver disorders are associated with bacterial overgrowth, dysbiosis, and increased intestinal permeability. However, the relationship between hepatectomy and microbiota has not been fully investigated, especially in healthy liver donors.
Many routine perioperative management can impact the state of the microbiome and therefore can impact clinical outcomes, like bowel preparation and antibiotics. Potential factors affecting the gut microbiota also include perioperative manipulation, stress released hormones, and opioids. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including volatile anesthetics and opioids, is associated with altered gut microbiota. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages. Epidural analgesia has been proved to improve gastrointestinal function in major abdominal and thoracic surgery. However, the effect of perioperative epidural anesthesia and analgesia on microbiota is not clear.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient controlled epidural analgesia | Active comparator | Procedure: Patient controlled epidural analgesiaUse of patient controlled epidural analgesia (PCEA) for postoperative pain control |
| Intravenous patient controlled analgesia | Sham comparator | Drug: Intravenous patient controlled analgesiaUse of intravenous patient controlled analgesia(IVPCA) for postoperative pain control |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Expected to receive living liver hepatectomy in National Taiwan University Hospital, age between 20 and 55 years old.
Key exclusion criteria (2 listed)
- Previous use of antibiotics within four weeks.
- Previous gastrointestinal surgery.
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 |
|---|---|---|
| Patient controlled epidural analgesiaAlso: PCEAPatient controlled epidural analgesia with marcaine 0.66mg/ml +fentanyl 1.75mcg/ml for postoperative pain control | Procedure or surgery | Patient controlled epidural analgesia |
| Intravenous patient controlled analgesiaAlso: IVPCAIntravenous patient controlled analgesia with morphine 1mg/ml for postoperative pain control | Drug | Intravenous patient controlled analgesia |
Primary outcome
Microbiota analysis
Time frame: one month
16S metagenomic sequence processing
5 secondary outcomes
LPS-binding protein
Time frame: one month
Intestinal fatty acid binding protein
Time frame: one month
IgA
Time frame: one month
IL-6
Time frame: one month
I-FEED scoring
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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.
Kuang-Cheng Chan, M.D.,PhD principal investigator
Department of Anesthesiology, Natioanal Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Living Donor Hepatectomy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 May 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microbiota analysis (time frame: one month). 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 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.