机构地区:[1]浙江大学医学院附属邵逸夫医院普外科,杭州310016 [2]浙江大学医学院,杭州310016
出 处:《中华外科杂志》2024年第7期697-702,共6页Chinese Journal of Surgery
基 金:国家自然科学基金(面上项目)(82172599);浙江省科学技术厅省级重点研发计划(2020C03024)。
摘 要:目的评估自固定自脱型胰肠吻合引流支架应用于胰肠吻合术的安全性和有效性。方法本研究为动物实验研究。基于胰肠吻合"瘘管愈合"学说创建的洪氏胰肠吻合技术研制自固定自脱型胰肠吻合引流支架,动物实验前已完成10项生物相容性体外试验。实验于2022年2—9月完成。取25只普通级巴马小型猪,采用丝线双重结扎胰腺颈部,使结扎远端主胰管扩张建模。将建模成功的23只巴马小型猪采用分层随机法分为三组,即支架组(11只)、手工缝合组(8只)、假手术组(4只)。比较支架组和手工缝合组的胰肠吻合时间、术后腹腔引流液淀粉酶浓度及胰肠吻合口承受的压力值。通过腹部X线片观察自固定自脱型胰肠吻合引流支架脱落时间。通过术后病理学检查观察胰肠吻合口愈合时间、愈合方式和狭窄率。采用独立样本t检验分析定量资料;采用Fisher确切概率法分析分类资料。结果支架组和手工缝合组的胰管直径和胰腺质地、胰肠吻合时间、术后腹腔引流液淀粉酶浓度和胰肠吻合口承受压力值的差异均无统计学意义(P值均>0.05)。腹部X线检查结果显示,引流支架组术后21 d胰肠吻合引流支架逐渐脱落排除体外,术后3个月后支架均脱落。大体和镜下病理学检查结果显示,支架组术后7 d吻合口愈合;手工缝合组术后14 d吻合口愈合。支架组和手工缝合组术后35 d内的吻合口狭窄率分别为2/8和6/8(Fisher确切概率法:P=0.132)。结论自固定自脱型胰肠吻合引流支架可安全有效地用于巴马小型猪的胰肠吻合术中,与手工缝合法胰肠吻合技术相比,吻合口愈合时间可能更早,狭窄率可能更低。Objectives:To evaluate the efficacy and safety of the self-fixing and self-detachable drainage stent in pancreaticojejunostomy and to provide supportive data for the follow clinical trials.Methods:This is an experimental research in animals which completed from February 2022 to September 2022.A self-fixing and self-detachable pancreaticojejunostomy drainage stent was designed for Hong′s pancreaticojejunostomy technique based on the theory of“fistula healing”in pancreaticojejunostomy.Ten biocompatibility tests were completed invitro before this study.Twenty-five Bama minipigs were selected and double-ligated in the neck of the pancreas to dilate the distal main pancreatic duct.Twenty-three of them were successfully modelled and divided into three groups by a stratified random method:pancreaticojejunostomy drainage stent group(referred to as stent group)with 11 pigs,pancreatic duct to jejunal mucosa anastomosis group(referred to as manual suture group)with 8 pigs,sham operation group with 4 pigs.The anastomic time,amylase content in postoperative abdominal drainage fluid and the tolerable pressure value of pancreaticojejunostomy were compared between the stent group and the manual suture group.An abdominal X-ray fluoroscopy examination was adopted to detect the detach time of the stent.A postoperative pathological examination was performed to verify the healing time,the type of treatment and the stricture rate of pancreaticojejunostomy.Quantitative data was analyzed by independent sample t-test.The classified data were analyzed by Fisher′s exact test.Results:There were no significant differences in the diameter of the pancreatic duct and pancreatic texture,the time of pancreaticojejunostomy,the amylase content in postoperative peritoneal drainage fluid,and the tolerable pressure value of the pancreaticojejunostomy between the stent group and the manual suture group(all P>0.05).Abdominal X-ray fluoroscopy showed that the stents gradually detached and were removed from the body 21 days after operation,and all
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