BACKGROUND:Urologic guidelines recommend perioperative instillation of chemotherapy after transurethral resection of bladder tumor (TURBT) to decrease tumor recurrence, yet implementation of this recommendation is partial due to associated morbidity. Hypertonic saline destroys cells by osmotic dehydration and might present a safer alternative. OBJECTIVE:To evaluate the safety of 3% hypertonic saline (Hypersal) intravesical instillation following TURBT in rats and in humans. METHODS:In 8 rats whose bladders were electrically injured, intravesical blue-dyed Hypersal was administered. We measured serum sodium levels before and after instillation and pathologically evaluated their pelvic cavity for signs of inflammation or blue discoloration. Twenty-four patients were recruited to the human trial (NIH-NCT04147182), 15 comprised the interventional and 10 the control group (one patient crossed over). Hypersal was given postoperatively. Serum sodium was measured before, 1 hour and 12–24 hours after instillation. Adverse effects were documented and compared between the groups. RESULTS:In rats, average sodium levels were 140.0 mEq/L and 140.3 mEq/L before and following instillation, respectively. Necropsy revealed no signs of inflammation or blue discoloration. In humans the average plasma sodium levels were 138.6 mEq∖L, 138.8 mEq∖L and 137.7 mEq∖L before, 1 hour and 12–24 hours after instillation, respectively. During the postoperative follow-up there was one case of fever. A month after the surgery, dysuria was reported by 5 patients while urgency and hematuria were reported by one patient each. The most severe adverse events were grade 2 on the Clavien-Dindo scale. Adverse events were similar in the control group. CONCLUSIONS:Hypersal instillation is safe and tolerable immediately after TURBT.

中文翻译：

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经膀胱尿道肿瘤电切术后立即输注高渗盐水以预防复发–一期研究

背景：泌尿外科指南建议在经尿道膀胱肿瘤切除术（TURBT）后进行围手术期滴注化疗，以减少肿瘤复发，但由于相关的发病率，该建议的部分实施。高渗盐水通过渗透脱水破坏细胞，可能是一种更安全的选择。目的：评估TURBT后3％高渗盐水（Hypersal）膀胱内滴注在大鼠和人类中的安全性。方法：对8只膀胱电损伤的大鼠进行膀胱内染成蓝色的Hyalsal。我们测量了滴注前后的血清钠水平，并通过病理学评估了它们的骨盆腔是否发炎或发蓝。招募了24名患者参加了人体试验（NIH-NCT04147182），15例为介入治疗组，另10例为对照组（一名交叉患者）。手术后进行了hypersal。滴注前，滴眼后1小时和12-24小时测量血清钠。记录不良反应并在各组之间进行比较。结果：在大鼠中，滴注前后平均钠水平分别为140.0 mEq / L和140.3 mEq / L。尸检显示没有炎症或蓝色变色的迹象。在人类中，滴注前，注射后1小时和12-24小时的平均血浆钠水平分别为138.6 mEq∖L，138.8 mEq∖L和137.7 mEq∖L。术后随访中有1例发烧。手术后一个月，有5名患者报告了排尿困难，而每名患者则报告了尿急和血尿。最严重的不良事件是Clavien-Dindo量表的2级。对照组的不良事件相似。结论：TURBT后立即输注全功夫是安全的并且可以忍受的。