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NCT Number: NCT07719933

Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort 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.

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terlipressin

Drug

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 22, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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