Tranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial.

BACKGROUND: Tranexamic acid (TXA) may reduce intraoperative blood loss, but it has not been investigated in pancreaticoduodenectomy (PD). METHODS: A pragmatic, multicentre, randomized, blinded, placebo-controlled trial was conducted. Adult patients undergoing planned PD for biliary, duodenal, or pancreatic diseases were randomly assigned to TXA or placebo groups. Patients in the TXA group were administered 1 g TXA before incision, followed by a maintenance infusion of 125 mg/h TXA. Patients in the placebo group were administered the same volume of saline as those in the placebo group. The primary outcome was blood loss during PD. The secondary outcomes included perioperative blood transfusions, operating time, morbidity, and mortality. RESULTS: Between September 2019 and May 2021, 218 patients were randomly assigned and underwent surgery (108 in the TXA group and 110 in the placebo group). Mean intraoperative blood loss was 659 ml in the TXA group and 701 ml in the placebo group (mean difference -42 ml, 95 per cent c.i. -191 to 106). Of the 218 patients, 202 received the intervention and underwent PD, and the mean blood loss during PD was 667 ml in the TXA group and 744 ml in the placebo group (mean difference -77 ml, 95 per cent c.i. -226 to 72). The secondary outcomes were comparable between the two groups. CONCLUSION: Perioperative TXA use did not reduce blood loss during PD. REGISTRATION NUMBER: jRCTs041190062 (https://jrct.niph.go.jp).

Removing part of the pancreas is an operation with a risk of major blood loss. Tranexamic acid is a drug thought to reduce blood loss. This study asked the question, 'Does tranexamic acid reduce blood loss during surgery on the pancreas?' Half of patients received tranexamic acid during surgery. The other half received only standard care. This study showed that tranexamic acid did not decrease the blood loss during the surgery and may have little effect in patients having a pancreaticoduodenectomy.

The significance of the time to arterial perfusion in intraoperative ICG angiography during colorectal surgery.

BACKGROUND: Intraoperative indocyanine green angiography (ICG-A) is a promising tool to confirm blood supply; however, the assessment is difficult without clear demarcation. In this study, the clinical impact of the time to arterial perfusion (TAP) on anastomotic leakage (AL) was evaluated, especially in patients without ICG demarcation. METHODS: The TAP was assessed using ICG-A during colorectal surgery in 110 patients. ICG demarcation required changing the transection line, and the TAP was measured at the new stump. The patients were divided into marginal flow (MF) and direct flow (DF) groups according to the arterial route. Delayed TAP was defined as the third quartile or slower TAP in each group. RESULTS: Sixty-six patients (60%) were classified into the MF group, including 64 patients who underwent rectal or sigmoid resection with high ligation of the inferior mesenteric artery. The cut-off value of the delayed TAP in the MF group was significantly slower than that in the DF group (30 and 22 s, respectively, p < 0.001). In the entire cohort, the transection line was changed in 2 patients, resulting in no AL. Nevertheless, AL still developed in 6 patients (5.4%), 5 of whom were in the MF group, and delayed TAP was found in 5 of 6 patients. Delayed TAP was significantly associated with AL in the MF group (p = 0.046). CONCLUSIONS: In patients without ICG demarcation, delayed TAP might be helpful for predicting the high-risk patients with AL in the MF group; however, performing diverting stoma or strictly careful observation might be a realistic reaction.

The survival benefit of neoadjuvant chemotherapy for resectable colorectal liver metastases with high tumor burden score.

BACKGROUND: The indications for neoadjuvant chemotherapy (NAC) in resectable colorectal liver metastases (CRLMs) remain unclear. Tumor burden score (TBS) is a prognostic tool based on tumor size and number of tumors. However, its utility in the NAC setting for initially resectable CRLM has never been investigated. METHODS: TBS is a distance from the origin on a Cartesian plane to the coordinates (x, y) = (tumor size in centimeter, number of tumors). TBS < 3 was defined as "TBS-low", whereas TBS ≥ 3 as "TBS-high". Between 2008 and 2018, 102 patients who underwent hepatectomy for resectable CRLM were retrospectively analyzed using the Kaplan-Meier method and Cox proportional hazards regression models. RESULTS: Among the TBS-low (n = 46) and TBS-high (n = 56) groups, baseline patient characteristics were mostly similar except for TBS-related parameters. NAC was more frequently administered in the TBS-high group (p = 0.038). The overall survival (OS) rates were similar between the two groups. Subgroup analysis showed that NAC was associated with non-significantly improved 5-year OS in the TBS-high group [76.1% with NAC and 54.9% without NAC (p = 0.093)]. In multivariate analysis, NAC was an independent prognostic factor for favorable OS only in the TBS-high group, while adjuvant chemotherapy (AC) was associated with improved OS only in the TBS-low group. CONCLUSION: In patients with resectable CRLM, the TBS-high population had a survival benefit from NAC, while the TBS-low population benefited from AC. TBS may serve as an indicator for patients who will benefit from NAC.

Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial.

INTRODUCTION: Pancreaticoduodenectomy (PD) is a major gastroenterological surgery that results in a substantial amount of blood loss. Several studies have demonstrated that major blood loss during PD is associated with both short-term and long-term poor outcomes. Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery. Nevertheless, the effect of perioperative TXA use in patients undergoing PD has not been investigated. This study aims to investigate the effect of TXA on blood loss during PD. METHODS AND ANALYSIS: A multicentre (six hospitals), randomised, blind (patient-blinded, surgeon-blinded, anaesthesiologist-blinded, monitor-blinded), placebo-controlled trial of TXA during PD was started in September 2019. Patients undergoing PD for biliary, duodenal or pancreatic diseases are randomly assigned to the TXA or placebo group. The stratification factors are the institutions and preoperative clinical diagnosis. Before skin incision, the participants in TXA group are administrated 1 g TXA as a loading infusion followed by a maintenance infusion of 125 mg/hour TXA until the end of surgery or 8 hours from the incision. Participants in the placebo group are administrated the same volume of saline that is indistinguishable from the TXA. The primary outcome is blood loss during PD. The secondary outcomes are intraoperative and postoperative (up to day 2) blood transfusions, operation time, anaesthesia time, postoperative laboratory variables, length of hospital stay, in-hospital and 90-day mortality and postoperative complications occurring within 28 days of surgery or requiring readmission. To date, 115 patients of a planned 220 have been enrolled in the study. ETHICS AND DISSEMINATION: This protocol was approved by the Nagoya University Clinical Research Review Board and is registered with Japan Registry of Clinical Trials on 15 August 2019. The results of this trial will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: jRCTs041190062.