Routine Intraoperative White Test for Bile Leak Detection in Liver Resection
NCT07511907
Bile Duct Diseases, Bile Duct Disorder
Warsaw, Masovian Voivodeship, Poland
View Trial DetailsNCT Number: NCT06905041
To assess the impact of preoperative anemia on postoperative outcomes in patients undergoing liver resection
Trial opening soon.
Get Notified20 year–75 year
All sexes
Observational
Globally, anemia affects approximately 33% of the population, with nearly 50% of cases attributed to iron deficiency. In Thailand, anemia remains a significant public health issue, with prevalence rates of 24% among women of reproductive age, 23.8% among nonpregnant women, and 32.2% among pregnant women. Iron deficiency anemia (IDA) is the leading and most common cause of anemia worldwide, and it is highly prevalent in Thailand. Moreover, the situation in Thailand is often exacerbated by the widespread incidence of thalassemia and hemoglobinopathies, with 30% to 40% of the population carrying thalassemia genes.
According to the World Health Organization (WHO), anemia is defined as a hemoglobin concentration of less than 12 g/dL in nonpregnant women and less than 13 g/dL in men. The prevalence of preoperative anemia among surgical patients has been reported to be between 32% and 48%. Preoperative anemia is one of the most common medical conditions encountered in surgical patients, with a prevalence ranging from 20% to 45% depending on the type of surgery. Specifically, in hepato-pancreato-biliary (HPB) surgery, 16.9% to 32.8% of patients present with anemia prior to surgery.
Preoperative anemia is a well-established predictor of the need for perioperative blood transfusions in liver resection, as supported by multiple studies. Perioperative allogeneic blood transfusions are associated with numerous adverse outcomes, both short-term and long-term. These include transfusion reactions, increased rates of postoperative infections, cardiopulmonary and thromboembolic events, prolonged mechanical ventilation, re-operations, extended hospital and ICU stays, elevated postoperative morbidity, increased tumor recurrence, reduced disease-specific survival, and decreased overall survival.
A large retrospective study reported a prevalence of preoperative anemia at 32.8%, which was associated with higher rates of postoperative major morbidities and mortality. After adjusting for confounding factors-such as age, type of liver resection, ASA classification, preoperative laboratory results, comorbidities, functional status, and diagnosis-patients with preoperative anemia were found to have a 21% higher risk of developing major morbidities within 30 days (adjusted odds ratio 1.21, 1.09-1.33). These morbidities included organ space infections, sepsis, septic shock, prolonged postoperative ventilator use (>48 hours), unplanned reintubation, pneumonia, and acute kidney injury requiring dialysis. However, preoperative anemia was not associated with increased postoperative mortality in liver resection (adjusted odds ratio 0.88, 0.66-1.16).
Furthermore, a retrospective study involving 4,170 patients demonstrated that preoperative anemia was associated with an increased risk of major postoperative complications compared to patients without anemia (24% versus 19%). After adjusting for confounders, including age, sex, race, obesity, extent of liver resection, comorbidities, functional status, and clinical and biochemical markers of liver dysfunction and portal hypertension, preoperative anemia was linked to a threefold increased risk of blood transfusion, a twofold increased risk of prolonged hospitalization, and higher healthcare costs in anemic patients. These findings suggest that anemia significantly impacts resource utilization in liver resection.
In a broader context, a study involving 227,425 patients from the ACS-NSQIP database who underwent major non-cardiac surgery reported that 30.4% of patients had preoperative anemia. The results showed that preoperative anemia was associated with increased morbidity and mortality within 30 days, even after adjusting for several known risk factors, including transfusions. Despite this evidence, there are limited studies specifically evaluating the impact of preoperative anemia on outcomes in specific surgeries, particularly liver resection.
The findings of this study could enhance physicians' understanding of the impact of preoperative anemia on postoperative outcomes, emphasizing the importance of its evaluation and treatment. Therefore, the assessment and management of preoperative anemia are essential components of patient blood management in liver resection. Proper assessment and timely intervention could mitigate associated risks and improve surgical outcomes.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Withdrawal criteria:
Time frame: From enrollment to the postoperative day 30
Time frame: From enrollment to the postoperative day 30
Contact information is provided by the study sponsor or research team.
Warangkana Lapisatepun, MD. PhD.
CONTACT
Worakitti Lapisatepun, MD.
CONTACT
Chiang Mai University
Other
The Impact of Preoperative Anemia on Postoperative Outcomes in Liver Resection: A Propensity Score Matching Analysis
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.
Published trials that share one or more normalized conditions with this study.
NCT07511907
Bile Duct Diseases, Bile Duct Disorder
Warsaw, Masovian Voivodeship, Poland
View Trial DetailsNCT07142876
Abdominal Injuries, Adenocarcinoma
View Trial DetailsNCT06894524
Adenocarcinoma, Carcinoma
View Trial DetailsNCT06638502
Colorectal Carcinoma Liver Metastases, Liver Resection
Baltimore, Maryland, United States
View Trial Details