Liver NeoplasmsNCT07719933
Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
An observational study of Liver Neoplasms and Postoperative Complications, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Liver resection is an important surgical treatment for patients with liver diseases. Despite advances in surgical and anesthetic management, postoperative complications remain a major concern and may affect patient recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Neoplasms, Postoperative Complications
- What is being tested?
- terlipressin
- Type of treatment
- Injection or infusion
- How many people
- 161 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 14 May 2025
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients who undergo laparoscopic hepatectomy for liver diseases at the First Affiliated Hospital of Sun Yat-sen University. Eligible patients will be prospectively enrolled according to predefined criteria and followed throughout the perioperative period. Clinical characteristics, intraoperative management, terlipressin exposure, and postoperative outcomes will be collected and analyzed.
Who may be able to join
- Adults aged 18 to 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective laparoscopic partial hepatectomy
- Provided written informed consent
Who cannot join
- Inability to tolerate the planned surgical procedure based on pre-anesthetic assessment
- Severe hepatic dysfunction (Child-Pugh class B or higher)
- Severe renal dysfunction (blood urea nitrogen > 9 mmol/L or serum creatinine > 178 μmol/L)
- Significant cardiovascular or cerebrovascular disease, including active coronary artery disease, severe valvular stenosis, hypertrophic obstructive cardiomyopathy, or history of extensive cerebral infarction
- Known allergy to study medications
- Body mass index (BMI) > 35 kg/m² or < 18 kg/m²
Show all 10Show fewer
- Hemoglobin level < 90 g/L
- Pregnancy or lactation
- Participation in another clinical trial within the preceding 3 months
- Any other condition considered inappropriate for study participation by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Liver resection is an important surgical treatment for patients with liver diseases. Despite advances in surgical and anesthetic management, postoperative complications remain a major concern and may affect patient recovery. Maintaining stable blood circulation during surgery is an important part of perioperative care.
Terlipressin is a vasoactive medication that may help maintain blood pressure and improve hemodynamic stability during surgery. However, the relationship between intraoperative continuous terlipressin infusion and postoperative outcomes after laparoscopic hepatectomy remains unclear.
Read more
This prospective observational cohort study aims to evaluate the association between continuous intraoperative terlipressin infusion and postoperative severe complications in patients undergoing laparoscopic hepatectomy.
Patients undergoing laparoscopic hepatectomy at the First Affiliated Hospital of Sun Yat-sen University will be enrolled and followed according to a predefined study protocol. Perioperative clinical information, anesthetic management data, terlipressin exposure, and postoperative outcomes will be collected and analyzed. The primary outcome is the occurrence of severe postoperative complications, defined as Clavien-Dindo grade III or higher complications.
Read the detailed description
Liver resection is an important surgical procedure for the treatment of patients with various liver diseases. Although advances in surgical techniques and perioperative management have improved outcomes, postoperative complications remain a significant concern after major abdominal surgery. Perioperative hemodynamic management plays an important role in maintaining adequate organ perfusion and may influence postoperative recovery.
Terlipressin is a vasoactive medication that increases vascular tone and may help maintain hemodynamic stability during surgery. In clinical practice, terlipressin may be administered during surgery based on the judgment of the attending anesthesiologist. However, the association between intraoperative continuous terlipressin infusion and postoperative outcomes in patients undergoing laparoscopic hepatectomy remains unclear.
This prospective observational cohort study was designed to evaluate the association between continuous intraoperative terlipressin infusion and postoperative severe complications in patients undergoing laparoscopic hepatectomy. Patients undergoing laparoscopic hepatectomy will be prospectively enrolled according to predefined eligibility criteria and followed according to the study protocol.
Clinical characteristics, perioperative management information, intraoperative terlipressin exposure, and postoperative outcomes will be collected prospectively. The primary objective of this study is to assess whether intraoperative continuous terlipressin infusion is associated with the incidence of severe postoperative complications after laparoscopic hepatectomy.
- Conditions
- Liver Neoplasms, Postoperative Complications
- Being tested
- terlipressin
- Keywords
- Terlipressin, Laparoscopic hepatectomy, Liver resection, Postoperative complications, Retrospective cohort study, Pleural effusion
- Medical subject headings
- Liver Neoplasms, Postoperative Complications, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressinDrug
Terlipressin is a vasopressin analogue used for perioperative hemodynamic management. In this prospective observational cohort study, continuous intraoperative terlipressin infusion was administered during laparoscopic hepatectomy according to the clinical judgment of the attending anesthesiologist. The use of terlipressin was based on routine clinical practice and was not assigned or mandated by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin Exposure Group | Patients who received continuous intraoperative terlipressin infusion during laparoscopic hepatectomy according to the clinical judgment of the attending anesthesiologist. Terlipressin administration was not assigned by the study protocol and was determined based on routine clinical practice. Receives: Drug: terlipressin | |
| Non-Terlipressin Exposure Group | Patients who underwent laparoscopic hepatectomy and did not receive continuous intraoperative terlipressin infusion during surgery. The absence of terlipressin administration was determined by routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe postoperative complications
Severe postoperative complications will be defined as Clavien-Dindo grade III or higher complications occurring after laparoscopic hepatectomy.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Apr 2024
- Primary completion31 Dec 2024
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xuyu Zhang, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719933
- Sponsor's protocol ID
- SunYetSen2023855
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because of institutional regulations and patient privacy protection requirements. Data may only be accessed by authorized researchers after appropriate ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
- ClinicalTrials.gov ID
- NCT07719933
- Acronym / sponsor ID
- SunYetSen2023855
- Conditions
- Liver Neoplasms, Postoperative Complications
- Keywords
- Terlipressin, Laparoscopic hepatectomy, Liver resection, Postoperative complications, Retrospective cohort study, Pleural effusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 22 Jul 2026 (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.
Liver resection is an important surgical treatment for patients with liver diseases. Despite advances in surgical and anesthetic management, postoperative complications remain a major concern and may affect patient recovery. Maintaining stable blood circulation during surgery is an important part of perioperative care.
Terlipressin is a vasoactive medication that may help maintain blood pressure and improve hemodynamic stability during surgery. However, the relationship between intraoperative continuous terlipressin infusion and postoperative outcomes after laparoscopic hepatectomy remains unclear.
This prospective observational cohort study aims to evaluate the association between continuous intraoperative terlipressin infusion and postoperative severe complications in patients undergoing laparoscopic hepatectomy.
Patients undergoing laparoscopic hepatectomy at the First Affiliated Hospital of Sun Yat-sen University will be enrolled and followed according to a predefined study protocol. Perioperative clinical information, anesthetic management data, terlipressin exposure, and postoperative outcomes will be collected and analyzed. The primary outcome is the occurrence of severe postoperative complications, defined as Clavien-Dindo grade III or higher complications.
Detailed description
Liver resection is an important surgical procedure for the treatment of patients with various liver diseases. Although advances in surgical techniques and perioperative management have improved outcomes, postoperative complications remain a significant concern after major abdominal surgery. Perioperative hemodynamic management plays an important role in maintaining adequate organ perfusion and may influence postoperative recovery.
Terlipressin is a vasoactive medication that increases vascular tone and may help maintain hemodynamic stability during surgery. In clinical practice, terlipressin may be administered during surgery based on the judgment of the attending anesthesiologist. However, the association between intraoperative continuous terlipressin infusion and postoperative outcomes in patients undergoing laparoscopic hepatectomy remains unclear.
This prospective observational cohort study was designed to evaluate the association between continuous intraoperative terlipressin infusion and postoperative severe complications in patients undergoing laparoscopic hepatectomy. Patients undergoing laparoscopic hepatectomy will be prospectively enrolled according to predefined eligibility criteria and followed according to the study protocol.
Clinical characteristics, perioperative management information, intraoperative terlipressin exposure, and postoperative outcomes will be collected prospectively. The primary objective of this study is to assess whether intraoperative continuous terlipressin infusion is associated with the incidence of severe postoperative complications after laparoscopic hepatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipressin Exposure Group | – | Drug: terlipressinPatients who received continuous intraoperative terlipressin infusion during laparoscopic hepatectomy according to the clinical judgment of the attending anesthesiologist. Terlipressin administration was not assigned by the study protocol and was determined based on routine clinical practice. |
| Non-Terlipressin Exposure Group | – | –Patients who underwent laparoscopic hepatectomy and did not receive continuous intraoperative terlipressin infusion during surgery. The absence of terlipressin administration was determined by routine clinical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients who undergo laparoscopic hepatectomy for liver diseases at the First Affiliated Hospital of Sun Yat-sen University. Eligible patients will be prospectively enrolled according to predefined criteria and followed throughout the perioperative period. Clinical characteristics, intraoperative management, terlipressin exposure, and postoperative outcomes will be collected and analyzed.
Key inclusion criteria (4 listed)
- Adults aged 18 to 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective laparoscopic partial hepatectomy
- Provided written informed consent
Key exclusion criteria (10 listed)
- Inability to tolerate the planned surgical procedure based on pre-anesthetic assessment
- Severe hepatic dysfunction (Child-Pugh class B or higher)
- Severe renal dysfunction (blood urea nitrogen > 9 mmol/L or serum creatinine > 178 μmol/L)
- Significant cardiovascular or cerebrovascular disease, including active coronary artery disease, severe valvular stenosis, hypertrophic obstructive cardiomyopathy, or history of extensive cerebral infarction
- Known allergy to study medications
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 |
|---|---|---|
| terlipressinTerlipressin is a vasopressin analogue used for perioperative hemodynamic management. In this prospective observational cohort study, continuous intraoperative terlipressin infusion was administered during laparoscopic hepatectomy according to the clinical judgment of the attending anesthesiologist. The use of terlipressin was based on routine clinical practice and was not assigned or mandated by the study protocol. | Drug | Terlipressin Exposure Group |
Primary outcome
Incidence of severe postoperative complications
Time frame: Within 30 days after surgery
Severe postoperative complications will be defined as Clavien-Dindo grade III or higher complications occurring after laparoscopic hepatectomy.
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 28 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because of institutional regulations and patient privacy protection requirements. Data may only be accessed by authorized researchers after appropriate ethical approval.
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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.
Xuyu Zhang, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms and Postoperative Complications, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 4 inclusion and 10 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 28 Jul 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 China. 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. 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?
Incidence of severe postoperative complications (time frame: Within 30 days after surgery). 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 28 Jul 2026.