新型一体化可携带~(125)I粒子胆道内外引流管的设计与临床应用
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摘要
目的设计新型一体化可携带125I粒子的胆道内外引流管,用于治疗胆管恶性梗阻病变,以达到胆汁引流和腔道内近距离放疗的双重效果。方法 2016年9月至2018年1月郑州大学第一附属医院15例恶性梗阻性黄疸患者行胆管支架植入术,后引入新型一体化可携带125I粒子的胆道内外引流管。评价技术成功率,临床有效率,并发症,支架通畅时间和患者生存期。结果引流管置入简单顺利,技术均获成功。术后1个月胆红素水平较术前明显下降(P<0.01),血象和免疫指标较前无明显变化(P>0.05)。术后2例(13.3%)患者发生胆管炎,2例(13.3%)胆道少量出血,对症治疗后恢复正常。未出现胆管穿孔、严重出血、放射性肠炎和放射源泄漏等严重并发症。随访55～402 d,6例(40.0%)发生胆管再梗阻,支架中位通畅时间255 d,6个月通畅率64.5%。5例死亡,10例存活,9个月存活率64.3%,中位生存时间368 d。结论新型一体化可携带125I粒子的胆道内外引流管可同期实现胆汁引流和近距离放疗,初步临床使用可行、安全、有效,长期疗效需进一步随访观察和对照研究。
Objective To design a new integrated portable biliary internal-external drainage catheter carrying125 I seeds used for the treatment of malignant biliary obstruction lesions so as to achieve the dual curative effects of biliary drainage and brachytherapy. Methods A total of 15 patients with malignant obstructive jaundice, who were admitted to the First Affiliated Hospital of Zhengzhou University, China,during the period from September 2016 to January 2018, were enrolled in this study. Biliary stent implantation was performed in all patients, which was followed by insertion of a new integrated portable biliary internal-external drainage catheter carrying125 I seeds. The technical success rate, clinical success rate, complications, stent patency time and patient survival rate were evaluated. Results The placement of the drainage tube was simple and smooth, and the technical procedure was successful in all patients. One month after treatment, the bilirubin level was decreased significantly when compared with preoperative one(P<0.01), while the blood indexes and immunological indicators showed no obvious changes(P>0.05). After treatment, 2 patients(13.3%) developed cholangitis and 2 patients(13.3%) had small amount of biliary bleeding, which returned to normal after symptomatic treatment. No severe complications such as perforation of bile duct, massive bleeding, radiation enteritis and radioactive source leakage, etc., occurred. The patients were followed up for 55-402 days, 6 patients(40.0%) developed biliary re-obstruction. The median patency time of stent was 255 days, and 6-month stent patency rate was 64.5%. Five patients died and 10 patients survived, the 9-month survival rate was 64.3%, the median survival time was 368 days. Conclusion By using the new integrated portable biliary internal-external drainage catheter carrying125 I seeds, the effects of bile drainage and brachytherapy can be simultaneously achieved. Preliminary clinical practice indicates that this new drainage catheter is feasible, safe and effective, although its long-term efficacy needs to be clarified with further follow-up observations and controlled studies.
Objective To design a new integrated portable biliary internal-external drainage catheter carrying125 I seeds used for the treatment of malignant biliary obstruction lesions so as to achieve the dual curative effects of biliary drainage and brachytherapy. Methods A total of 15 patients with malignant obstructive jaundice, who were admitted to the First Affiliated Hospital of Zhengzhou University, China,during the period from September 2016 to January 2018, were enrolled in this study. Biliary stent implantation was performed in all patients, which was followed by insertion of a new integrated portable biliary internal-external drainage catheter carrying125 I seeds. The technical success rate, clinical success rate, complications, stent patency time and patient survival rate were evaluated. Results The placement of the drainage tube was simple and smooth, and the technical procedure was successful in all patients. One month after treatment, the bilirubin level was decreased significantly when compared with preoperative one(P<0.01), while the blood indexes and immunological indicators showed no obvious changes(P>0.05). After treatment, 2 patients(13.3%) developed cholangitis and 2 patients(13.3%) had small amount of biliary bleeding, which returned to normal after symptomatic treatment. No severe complications such as perforation of bile duct, massive bleeding, radiation enteritis and radioactive source leakage, etc., occurred. The patients were followed up for 55-402 days, 6 patients(40.0%) developed biliary re-obstruction. The median patency time of stent was 255 days, and 6-month stent patency rate was 64.5%. Five patients died and 10 patients survived, the 9-month survival rate was 64.3%, the median survival time was 368 days. Conclusion By using the new integrated portable biliary internal-external drainage catheter carrying125 I seeds, the effects of bile drainage and brachytherapy can be simultaneously achieved. Preliminary clinical practice indicates that this new drainage catheter is feasible, safe and effective, although its long-term efficacy needs to be clarified with further follow-up observations and controlled studies.
引文
[1] Nam HS, Kang DH, Kim HW, et al. Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction[J]. World J Gastroenterol, 2017, 23:1627-1636.
[2]姚红响,陈根生,叶冠雄,等.单纯胆管支架与125I粒子支架腔内治疗恶性梗阻性黄疸[J].中华肝胆外科杂志, 2014, 20:869-872.
[3] Jiao D, Wu G, Ren J, et al. Study of self-expandable metallic stent placement intraluminal125I seed strands brachytherapy of malignant biliary obstruction[J]. Surg Endosc, 2017, 31:4996-5005.
[4]郭金和,朱光宇,朱海东,等.胆管内照射支架的研发及临床应用的初步结果[J].中华医学杂志, 2011, 91:2310-2313.
[5]姜中华,张秀华,王飞,等.内镜辅助双极射频消融在胆管恶性狭窄金属支架堵塞后再通中的应用[J].中华肝胆外科杂志, 2015, 21:678-681.
[6] Chen Y, Wang XL, Yan ZP, et al. The use of125I seed strands for intraluminal brachytherapy of malignant obstructive jaundice[J]. Cancer Biother Radiopharm, 2012, 27:317-323.
[7]王勇,刘会春,李宗狂,等.经皮胆道支架联合125I粒子腔内植入治疗恶性梗阻性黄疸的初步研究[J].中华放射学杂志, 2014, 48:403-407.
[8]黄兢姚,杨维竹,江娜,等.125I粒子条胆道支架治疗恶性胆道梗阻38例[J].介入放射学杂志, 2014, 23:633-636.
[9]陈旭,朱光宇,滕皋军,等.胆管内照射支架应用的实验研究[J].介入放射学杂志, 2012, 21:399-404.
[10] Liu Y, Liu JL, Cai ZZ, et al. A novel approach for treatment of unresectable extrahepatic bile duct carcinoma:design of radioactive stents and an experimental trial in healthy pigs[J]. Gastrointest Endosc, 2009, 69:517-524.
[11]戴真煜,姚立正,李文会,等.经皮胆道支架联合支架125I粒子条植入治疗恶性胆道梗阻[J].介入放射学杂志, 2011, 20:706-708.
[12]李文会,罗剑钧,戴真煜,等.腔内近距离放疗联合及支架植入治疗恶性胆道梗阻[J].介入放射学杂志, 2015, 24:215-218.
[13] Dechao J, Han X, Yanli W, et al. Y-configured metallic stent combined with125I seed strands cavity brachytherapy for a patient with typeⅣKlatskin tumor[J]. J Contemp Brachytherapy, 2016,8:356-360.
[14]邹雷,金焰,乔鸥,等.125I粒子可更换持续照射系统治疗不可切除肝门部胆管癌[J].中华肝胆外科杂志, 2015, 21:418-420.
[15]王涛,刘胜,郑延波,等.125I粒子条联合胆道内支架治疗恶性梗阻性黄疸的临床疗效[J].中华肿瘤杂志, 2016, 38:228-231.
[16]张西坤,徐忠法,牛洪欣,等.移动式125I粒子链共轴引流导管在恶性梗阻性黄疸治疗中的应用[J].山东医药, 2017, 57:97-98.
[17]刘素丽,赵春青,王佳,等.内镜下碘-125粒子置入腔内照射治疗胆管癌的临床研究[J].中华消化内镜杂志, 2015, 32:529-533.
[18]潘洪涛,刘会春,费圣贤,等.胆道支架联合125I粒子腔内照射治疗肝门胆管癌的临床疗效[J].中华放射学杂志, 2016,50:393-396.
[19] Zhu HD, Guo JH, Zhu GY, et al. A novel biliary stent loaded with125I seeds in patients with malignant biliary obstruction:preliminary results versus a conventional biliary stent[J]. J Hepatol,2012, 56:1104-1111.
[20]郝亮,汪建,王斌,等.模拟胆管内不同弧度125I粒子链的剂量学研究[J].中华放射医学与防护杂志, 2017, 37:758-762.
[2]姚红响,陈根生,叶冠雄,等.单纯胆管支架与125I粒子支架腔内治疗恶性梗阻性黄疸[J].中华肝胆外科杂志, 2014, 20:869-872.
[3] Jiao D, Wu G, Ren J, et al. Study of self-expandable metallic stent placement intraluminal125I seed strands brachytherapy of malignant biliary obstruction[J]. Surg Endosc, 2017, 31:4996-5005.
[4]郭金和,朱光宇,朱海东,等.胆管内照射支架的研发及临床应用的初步结果[J].中华医学杂志, 2011, 91:2310-2313.
[5]姜中华,张秀华,王飞,等.内镜辅助双极射频消融在胆管恶性狭窄金属支架堵塞后再通中的应用[J].中华肝胆外科杂志, 2015, 21:678-681.
[6] Chen Y, Wang XL, Yan ZP, et al. The use of125I seed strands for intraluminal brachytherapy of malignant obstructive jaundice[J]. Cancer Biother Radiopharm, 2012, 27:317-323.
[7]王勇,刘会春,李宗狂,等.经皮胆道支架联合125I粒子腔内植入治疗恶性梗阻性黄疸的初步研究[J].中华放射学杂志, 2014, 48:403-407.
[8]黄兢姚,杨维竹,江娜,等.125I粒子条胆道支架治疗恶性胆道梗阻38例[J].介入放射学杂志, 2014, 23:633-636.
[9]陈旭,朱光宇,滕皋军,等.胆管内照射支架应用的实验研究[J].介入放射学杂志, 2012, 21:399-404.
[10] Liu Y, Liu JL, Cai ZZ, et al. A novel approach for treatment of unresectable extrahepatic bile duct carcinoma:design of radioactive stents and an experimental trial in healthy pigs[J]. Gastrointest Endosc, 2009, 69:517-524.
[11]戴真煜,姚立正,李文会,等.经皮胆道支架联合支架125I粒子条植入治疗恶性胆道梗阻[J].介入放射学杂志, 2011, 20:706-708.
[12]李文会,罗剑钧,戴真煜,等.腔内近距离放疗联合及支架植入治疗恶性胆道梗阻[J].介入放射学杂志, 2015, 24:215-218.
[13] Dechao J, Han X, Yanli W, et al. Y-configured metallic stent combined with125I seed strands cavity brachytherapy for a patient with typeⅣKlatskin tumor[J]. J Contemp Brachytherapy, 2016,8:356-360.
[14]邹雷,金焰,乔鸥,等.125I粒子可更换持续照射系统治疗不可切除肝门部胆管癌[J].中华肝胆外科杂志, 2015, 21:418-420.
[15]王涛,刘胜,郑延波,等.125I粒子条联合胆道内支架治疗恶性梗阻性黄疸的临床疗效[J].中华肿瘤杂志, 2016, 38:228-231.
[16]张西坤,徐忠法,牛洪欣,等.移动式125I粒子链共轴引流导管在恶性梗阻性黄疸治疗中的应用[J].山东医药, 2017, 57:97-98.
[17]刘素丽,赵春青,王佳,等.内镜下碘-125粒子置入腔内照射治疗胆管癌的临床研究[J].中华消化内镜杂志, 2015, 32:529-533.
[18]潘洪涛,刘会春,费圣贤,等.胆道支架联合125I粒子腔内照射治疗肝门胆管癌的临床疗效[J].中华放射学杂志, 2016,50:393-396.
[19] Zhu HD, Guo JH, Zhu GY, et al. A novel biliary stent loaded with125I seeds in patients with malignant biliary obstruction:preliminary results versus a conventional biliary stent[J]. J Hepatol,2012, 56:1104-1111.
[20]郝亮,汪建,王斌,等.模拟胆管内不同弧度125I粒子链的剂量学研究[J].中华放射医学与防护杂志, 2017, 37:758-762.