Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative C… (NCT07719933) | Clinical Trial Compass
CompletedNot Applicable
Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
China161 participantsStarted 2024-04-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of severe postoperative complications
Timeframe: Within 30 days after surgery
Trial details
NCT IDNCT07719933
SponsorFirst Affiliated Hospital, Sun Yat-Sen University