Solanki Shailesh, Kanojia Ravi Prakash, Gupta Pramod Kumar, Singhai Palak, Lal Sadhna Bhasin, Mahajan Jai Kumar
Department of Pediatric Surgery, PGIMER, Chandigarh, India.
Department of Biostatistics, PGIMER, Chandigarh, India.
J Indian Assoc Pediatr Surg. 2023 Jul-Aug;28(4):307-313. doi: 10.4103/jiaps.jiaps_29_23. Epub 2023 Jul 11.
Kasai portoenterostomy (KPE) is the initial treatment for biliary atresia (BA). Even after initial jaundice clearance, a significant number of children presented with the reappearance of symptoms due to ongoing fibrosis involving porta and intrahepatic ducts. Mitomycin-C (MMC) is an antifibrotic agent, and the study hypothesized that local application of MMC at porta can decrease fibrosis, which can improve jaundice clearance and lead to better native liver survival (NLS).
This prospective randomized control trial included children with BA, who were allocated to groups A or B. The patients in both groups underwent standard KPE; in addition, a 5 French infant feeding tube (IFT) was placed near the porta through the Roux limb in Group B children. During the postoperative period, MMC was locally instilled over the porta in Group B children through IFT. Postoperative jaundice clearance and NLS were assessed and compared.
A total of 27 children were enrolled in the study, 16 in Group A and 11 in Group B. Both groups were comparable preoperatively. Although the NLS was not statistically significant in Group B, the survival was quite higher, that was 91%, 81%, and 73% at 6 months, 1 year, and 2 years, respectively, compared to 63%, 50%, and 38% in Group A.
Children in Group B clinically showed an early jaundice clearance and a better trend of serial bilirubin levels as well as longer NLS than Group A, but it was not statistically significant. The procedure was technically easy, and no complication was encountered related to surgical technique or MMC instillation.
肝门空肠吻合术(KPE)是胆道闭锁(BA)的初始治疗方法。即使在初始黄疸清除后,仍有相当数量的儿童因肝门和肝内胆管持续纤维化而再次出现症状。丝裂霉素-C(MMC)是一种抗纤维化药物,该研究假设在肝门局部应用MMC可减少纤维化,从而改善黄疸清除并提高自体肝生存率(NLS)。
这项前瞻性随机对照试验纳入了BA患儿,将其分为A组或B组。两组患者均接受标准KPE;此外,B组患儿通过Roux袢在肝门附近放置一根5号法国婴儿喂养管(IFT)。术后期间,通过IFT向B组患儿的肝门局部滴注MMC。评估并比较术后黄疸清除情况和NLS。
共有27名儿童参与研究,A组16名,B组11名。两组术前情况具有可比性。虽然B组的NLS无统计学意义,但生存率相当高,6个月、1年和2年时分别为91%、81%和73%,而A组分别为63%、50%和38%。
B组患儿临床显示黄疸清除较早,系列胆红素水平趋势较好,NLS也比A组长,但无统计学意义。该操作技术上简单,未遇到与手术技术或MMC滴注相关的并发症。