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

NCT07719933 | Completed FDA Drug

• 1 other identifier: SunYetSen2023855
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Neoplasms; Postoperative Complications

Keywords

Terlipressin; Laparoscopic hepatectomy; Liver resection; Postoperative complications; Retrospective cohort study; Pleural effusion

Outcome Measures

Primary Outcomes (1)

• Incidence of severe postoperative complications

  Severe postoperative complications will be defined as Clavien-Dindo grade III or higher complications occurring after laparoscopic hepatectomy.

  Within 30 days after surgery

Study Arms (2)

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.

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.

Interventions

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.

Terlipressin Exposure Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Liver Neoplasms; Postoperative Complications; Pleural Effusion

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Xuyu Zhang, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: May 14, 2025
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)