The Cost-effectiveness Analysis of Percutaneous Transhepatic Metal Versus Plastic Biliary Stent Implantation for Treating Malignant Biliary Obstruction (Multiple Center Investigation)

Objective: To compare metal versus plastic biliary stent implantation for treatment of malignant biliary obstruction in cost-effectiveness ratio (CER). Methods: Percutaneous transhepatic self-expandable metal stent (MS, n=61) or 10F plastic stent (PS, n=34) implantation was performed in 95 patients with malignant biliary obstruction in three hospitals of Guangdong province. All patients were followed up until death or at least one year after the procedure. Kaplan-Meier analysis was used to compare the survival and stent patency rates of the patients in the two groups. CERs of two groups were calculated. The main indexes were CERsurvival period (total cost/median survival period), CERpatency period (total cost/median patency period). Results: The total costs of treatment were 53177±3139 yuan (RMB) in MS group and 42564±4950 yuan (RMB) in PS group respectively (P>0.05). CER in MS group was superior to that in PS group (CERsurvival period was 237.4 yuan /d vs 452.6 yuan /d, respectively; CERpatency period was 231.2 yuan /d vs 472.9 yuan /d, respectively). Conclusion: The metal stent implantation is superior to the plastic stent in the CER for treatment of malignant biliary obstruction.

Percutaneous transhepatic metal versus plastic biliary stent in treating malignant biliary obstruction: a multiple center investigation

OBJECTIVE: To compare the efficacy of metal versus plastic biliary stent implantation in the treatment of malignant biliary obstruction. METHODS: Percutaneous transhepatic self-expandable metal stent (MS, n=61) and 10F plastic stent (PS, n=34) were placed in 95 patients with malignant biliary obstruction in three hospitals of Guangdong province. All patients were followed up until death or at least one year after the procedure. Kaplan-Meier analysis was used to compare the survival of the patients and the rates of stent patency. RESULTS: The 30-day mortality rate was lower in the MS group (6/61, 9.8%) than in the PS group (9/34, 26.5%, P<0.05). The 30-day reobstruction rate and the complication rate were 15.0%, 16.4% in the MS group and 32. 4%, 29. 4% in the PS group, respectively (P<0. 01). The median patency period of stents and median survival period of the patients were 230 days, 224 days in the MS group and 90 days, 94 days in the PS group, respectively (P<0. 01). CONCLUSION: Metal stent is clinically superior to plastic stent in the treatment of malignant biliary obstruction.

Feasibility and efficacy evaluation of metallic biliary stents eluting gemcitabine and cisplatin for extrahepatic cholangiocarcinoma

BACKGROUND Effective endoscopic management is fundamental for the treatment of extrahepatic cholangiocarcinoma(ECC).However,current biliary stents that are widely used in clinical practice showed no antitumor effect.Drug-eluting stents(DESs)may achieve a combination of local chemotherapy and biliary drainage to prolong stent patency and improve prognosis.AIM To develop novel DESs coated with gemcitabine(GEM)and cisplatin(CIS)-coloaded nanofilms that can maintain the continuous and long-term release of antitumor agents in the bile duct to inhibit tumor growth and reduce systemic toxicity.METHODS Stents coated with different drug-eluting components were prepared by the mixed electrospinning method,with poly-L-lactide-caprolactone(PLCL)as the drug-loaded nanofiber membrane and GEM and/or CIS as the antitumor agents.Four different DESs were manufactured with four drug-loading ratios(5%,10%,15%,and 20%),including bare-loaded(PLCL-0),single-drug-loaded(PLCL-GEM and PLCL-CIS),and dual-drug-loaded(PLCL-GC)stents.The drug release property,antitumor activity,and biocompatibility were evaluated in vitro and in vivo to confirm the feasibility and efficacy of this novel DES for ECC.RESULTS The in vitro drug release study showed the stable,continuous release of both GEM and CIS,which was sustained for over 30 d without an obvious initial burst,and a higher drug-loaded content induced a lower release rate.The drug-loading ratio of 10%was used for further experiments due to its ideal inhibitory efficiency and relatively low toxicity.All drug-loaded nanofilms effectively inhibited the growth of EGI-1 cells in vitro and the tumor xenografts of nude mice in vivo;in addition,the dual-loaded nanofilm(PLCL-GC)had a significantly better effect than the single-drug-loaded nanofilms(P<0.05).No significant differences in the serological analysis(P>0.05)or histopathological changes were observed between the single-loaded and drug-loaded nanofilms after stent placement in the normal porcine biliary tract.CONCLUSION This novel PLCL-GEM and CIS-eluting stent maintains continuous,stable drug release locally and inhibits tumor growth effectively in vitro and in vivo.It can also be used safely in normal porcine bile ducts.We anticipate that it might be considered an alternative strategy for the palliative therapy of ECC patients.

Radiological interventions in malignant biliary obstruction

Malignant biliary obstruction is commonly caused by gall bladder carcinoma, cholangiocarcinoma and metastatic nodes. Percutaneous interventions play an important role in managing these patients. Biliary drainage, which forms the major bulk of radiological interventions, can be pal iative in inoperable patients or pre-operative to improve liver function prior to surgery. Other interventions include cholecystostomy and radiofrequency ablation. We present here the indications, contraindications, technique and complications of the radiological interventions performed in patients with malignant biliary obstruction.

Endoscopic ultrasound-guided biliary drainage after failed endoscopic retrograde cholangiopancreatography: The road is open for almighty biliopancreatic endoscopists!

Commentary on the article written and published by Peng et al,investigating the role of endoscopic ultrasound(EUS)-guided biliary drainage for palliation of malignant biliary obstruction after failed endoscopic retrograde cholangiopan-creatography(ERCP).For 40 years endoscopic biliary drainage was synonymous with ERCP,and EUS was used mainly for diagnostic purposes.The advent of therapeutic EUS has revolutionized the field,especially with the development of a novel device such as electrocautery-enhanced lumen-apposing metal stents.Complete biliopancreatic endoscopists with both skills in ERCP and in interven-tional EUS,would be ideally suited to ensure patients the best drainage technique according to each individual situation.

Malignant biliary obstruction: treatment with interventional radiology

Objective To evaluate the method of palliative drainage by means of metallic indwelling stents or plastic tubes for patients with malignant biliary obstruction.Methods From January 1995 to Febuary 2001, 243 consecutive patients (161 men and 82 women; aged 26-91 years, mean of 61.3 years) with malignant biliary obstruction were treated with transhepatic placement of metallic stents and/or plastic tubes. Among them, 47 patients had pancreatic carcinoma, 98 cholangiocarcinoma, 28 metastatic carcinoma and 60 hepatic carcinoma. 169 stents of nine types were used in this series. After stenting, 47 patients were treated for local tumors. Procedure- and device-related complications were recorded. Patient survival and stent patency rates were calculated with Kaplan-Meier survival analysis.Results One hundred and three patients underwent successfully stent placement for the first time. Others had their stents installed 1 - 2 weeks after catheterization. Stents were used in 132 patients. Ninety-five patients were treated with a single stent. Seventeen patients had two stents installed for bilateral drainage, 20 patients had two stents installed from top to bottom to create stenting of adequate length, and 12 patients had stents placed across the ampulla. The 2-month mortality rate was 8. 64% (21/243). Major complications occurred in two patients (0.8%, 2/243). Minor complications included self-limited bleeding into the drainage tubes and fever. The average patency of the initial stent was 7. 5 months and average survival was 9 months. Thirteen patients received brachytherapy in their stents, 15 extra radiation therapy, and 19 intra-arterial infusion chemotherapy. The 47 patients treated for local tumors had an average survival of 11. 3 months (log rank 32.8, P < 0.001) with an average patency of 9. 7 months(log rank 4. 7, P<0. 05).Conclusion Percutaneous transhepatic bile drainage as a palliative procedure is well tolerated by patients. After stenting, treatment for local tumor may prolong the duration of stent patency and the survival of patients.

Percutaneous imaging-guided interventions for acute biliary disorders in high surgical risk patients

AIM:To evaluate the efficacy of percutaneous imagingguided biliary interventions in the management of acute biliary disorders in high surgical risk patients.METHODS:One hundred and twenty two patients underwent 139 percutaneous imaging-guided biliary interventions during the period between January 2007 to December 2009.The patients included 73 women and 49 men with a mean age of 61 years(range 35-90 years).Fifty nine patients had acute biliary obstruction,26 patients had acute biliary infection and 37 patients had abnormal collections.The procedures were performed under computed tomography(CT)-(73 patients),sonographic-(41 patients),and fluoroscopic-guidance(25 patients).Success rates and complications were determined.The χ2 test with Yates' correction for continuity was applied to compare between these procedures.A P value < 0.05 was considered significant.RESULTS:The success rates for draining acute biliary obstruction under CT-,fluoroscopy-or ultrasoundguidance were 93.3,62.5 and 46.1,respectively with significant P values(P = 0.026 and 0.002,respectively).In acute biliary infection,successful drainage was achieved in 22 patients(84.6).The success rates in patients drained under ultrasound-and CT-guidance were 46.1 and 88.8,respectively and drainage under CT-guidance was significantly higher(P = 0.0293).In 13 patients with bilomas,percutaneous drainage was successful in 11 patients(84.6).Ten out of 12 cases with hepatic abscesses were drained with a success rate of 83.3.In addition,the success rate of drainage in 12 cases with pancreatic pseudocysts was 83.3.The reported complications were two deaths,four major and seven minor complications.CONCLUSION:Percutaneous imaging-guided biliary interventions help to promptly diagnose and effectively treat acute biliary disorders.They either cure the disorders or relieve sepsis and jaundice before operations.

经皮胆道引流术治疗恶性梗阻性黄疸

目的 回顾性分析恶性梗阻性黄疸的介入性经皮胆道引流治疗方法及其疗效。方法 对4 7例患者采用经皮肝穿刺胆道引流术治疗恶性梗阻性黄疸。先行PTC后探查通过阻塞段 ,如不能越过阻塞段 ,则直接进行外引流 ;如能越过阻塞段 ,则置入内外引流管作内外引流或置入金属支架或塑料内涵管作内引流。结果 内引流组 18例 ,15例置入金属支架 ,共 18枚 ,3例置入塑料内涵管 ,共 4根 ;内外引流组 15例 ,置入 18根内外引流管 ;外引流组 14例 ,置入 17根外引流管。术后 1周总胆红素从术前的 (5 14 .1± 2 0 4 .3) μmol/L降至 (2 38.4± 14 2 .8) μmol/L(P <0 .0 0 1) ,碱性磷酸酶与丙氨酸转氨酶均下降明显 (P均 <0 .0 0 1)。 4例于术后 1个月内死亡。跟踪随访 37例 ,平均随访 5 .3个月 ,8例仍存活。随访期内 18例 (48.6 % )总胆红素降至正常范围。结论 经皮肝穿刺胆道引流术是对恶性梗阻性黄疸的一种安全、有效的姑息性治疗方法 ,可明显缓解黄疸、减轻痛苦、提高生存质量 ,并可改善肝脏功能 ,有限地延长生存时间。

经皮胆道支架联合支架旁^(125)Ⅰ粒子条植入治疗恶性胆道梗阻

目的评估经皮胆道支架联合支架旁125Ⅰ粒子条植入治疗恶性胆道梗阻的疗效。方法选取28例恶性胆道梗阻患者,行经皮胆道支架联合支架旁125Ⅰ粒子条植入,疗效评价标准:统计手术成功率、临床症状缓解情况、术后并发症以及生存期。结果所有患者手术均获得成功,未发生与手术相关严重并发症,术后梗阻性黄疸症状逐步改善,术后1个月血清胆红素水平均较术前明显下降(P<0.01);中位生存期为4.7个月,平均生存期为5.7个月。结论经皮胆道支架联合支架旁125Ⅰ粒子条植入治疗胆道梗阻安全有效,但远期效果仍需进一步观察。

金属支架、内涵管治疗恶性胆管梗阻的临床疗效比较

目的 比较金属支架与塑料支架 (内涵管 )置入术治疗恶性胆管梗阻的临床疗效。资料与方法 95例实施经皮穿肝胆总管支架置入术的恶性胆管梗阻患者 ,其中 6 1例置入自膨式金属支架 (支架组 ) ,34例置入 10F塑料内涵管 (内涵管组 )。所有患者均随访至死亡或至少术后 1年。用Kaplan Meier方法分析比较两组患者的生存率及支架开通率。结果 支架组患者的 30天死亡率 (6 /6 1,9.8%)低于内涵管组 (9/34 ,2 6 .5 %,P <0 .0 5 )。支架组 30天再阻塞率 (15 .0 %)和并发症发生率 (16 .4%)均明显低于内涵管组 (分别为 32 .4%和 2 9.4%,P <0 .0 1)。支架组中位开通期 (2 30天 )和中位生存期 (2 2 4天 )明显长于内涵管组 (分别为 90天和 94天 ,P <0 .0 1)。结论 金属支架置入术治疗恶性胆管梗阻临床疗效优于内涵管置入术。

高位胆管梗阻的介入治疗和近期疗效分析

目的回顾性分析高位梗阻性黄疸患者介入治疗方法及近期疗效。方法100例接受经皮肝穿刺胆汁引流或胆道支架置入治疗的高位梗阻性黄疸患者,其中胆管癌39例,转移瘤22例,肝移植后胆管病变18例,原发性肝癌15例,胆囊癌6例。测定术前,术后3～7d、8～14d血胆红素水平并进行显著性检验。结果79例行单纯外引流或内外引流,21例行胆道支架置入术,所用支架4种31枚。术前血清胆红素含量与术后3～7d胆红素水平差别有显著性(P<0.05),与术后8～14d胆红素水平比较有非常显著的差异(P<0.01)。结论介入治疗高位梗阻性黄疸方法简单、近期疗效满意。

胆道双支架置入治疗肝门部胆管癌

目的 探讨肝门部胆管癌胆道双支架置入的方法、术式和临床疗效。方法 6例肝门部BismuthⅣ型胆管癌患者 ,采取经皮肝穿刺胆道双支架置入治疗 ,根据左右肝管分叉角度的不同采取不同的双支架置入术式。当分叉呈钝角时 ,仅通过右肝管单一穿刺通道置入双支架 ;当分叉呈锐角时 ,2个穿刺通道都在右腋中线进行 ,方便了操作和术后护理。结果 术后患者黄疸明显减轻或消退 ,血清胆红素水平较术前平均下降了 (10 4± 2 9) μmol L(P <0 .0 1) ,收到了较好的近期治疗效果。 6例中有 2例分别于术后 4和 6个月支架再阻塞。结论 胆道双支架置入对于肝门部BismuthⅣ型胆管癌疗效可靠 ,根据左右肝管分叉角度采取不同的双支架置入术式 ,方法可行。

双途径介入治疗原发性肝癌合并梗阻性黄疸

目的 回顾性分析经皮胆道内支架置入术和动脉内栓塞术双介入途径治疗原发性肝癌合并梗阻性黄疸的技术与疗效。方法 对12例原发性肝癌合并梗阻性黄疸的患者采用在经皮肝穿刺胆道内支架置入术的基础上,行动脉内化疗栓塞术的双介入治疗。肝内肿瘤5例为巨块型,6例为多发结节型,1例为弥漫型,病变均累及肝门部或左右肝管。结果 12例患者共置入14枚支架,3支外引流管。7例左右肝管之间相通,各置入1枚支架;5例左右肝管之间无法相通,分别通过支架或外引流管进行内引流或外引流,其中1例于左右肝管间及左肝管与胆总管之间各置入1枚支架。术后1周,血清总胆红素(TBIL)从术前的(405.3±175.4)μmol/L降至(188.3±101.5)μmol/L(P<0.01),碱性磷酸酶与丙氨酸转氨酶均下降明显(P均<0.05)。术后1个月,TBIL均降至100μmol/L以下,其中5例降至正常范围。胆道引流术后进行肝内肿瘤的动脉内化疗栓塞术1～4次(平均2.1次)。均未出现与介入治疗相关的严重并发症。平均生存9.5个月,5例仍存活。结论 经皮胆道内支架置入术与动脉内栓塞术双途径介入可安全、有效地治疗合并梗阻性黄疸的原发性肝癌,可明显缓解黄疸,改善肝脏功能,延长患者生命。

胆道内支架置入术治疗恶性梗阻性黄疸的疗效分析

目的 探讨经皮肝胆道内支架置入治疗恶性梗阻性黄疸的疗效及并发症。方法 对 32例恶性梗阻性黄疸患者经皮肝穿胆道内行支架置入术 ,其中 2 8例为内涵管 ,4例为金属内支架。随访 35～ 376天 ,观察近中期疗效和并发症。结果 经皮肝胆道内支架置入术技术成功率为 10 0 %。置入术后 1周血总胆红素水平较置入前明显下降 (P<0 .0 0 1)。开通时间平均为 10 1天 ,半年开通率为 5 6 .2 5 %。并发症发生率 2 4.98% ,为主要包括胰腺炎和逆行胆道感染等。结论 经皮肝胆道内架置入术疗效可靠 ,是一种安全 ,可作为恶性胆管阻塞介入治疗的一种姑息性疗法。

经皮肝穿刺胆道引流术及胆管内支架植入术在恶性梗阻性黄疸治疗中的应用

目的评价经皮肝穿刺胆道引流(PTBD)及胆管内支架植入术(PTIBS)治疗恶性梗阻性黄疸的疗效。方法对56例恶性梗阻性黄疸患者采取PTBD或PTIBS,所有患者均经B超、CT或MRI明确诊断,并确定梗阻部位,其中高位梗阻19例,低位梗阻37例。梗阻原因包括肝癌14例,胆管癌11例,胆囊癌5例,胃癌伴淋巴结转移14例,壶腹部占位1例,胰头癌11例。术中根据造影结果选择合适方案。结果所有56例均成功完成手术。其中行PTBD11例,PTIBS40例,PTBD并PTIBS5例。TBIL由术前(295.65±152.86)μmol/L降至术后(151.05±107.36)μmol/L(P<0.01)。术后感染对黄疸消退有影响(P<0.01)。梗阻部位与黄疸消退情况比较差异无统计学意义(P=0.063)。结论经皮肝穿刺胆道引流及支架植入术治疗恶性梗阻性黄疸安全有效,可明显减轻黄疸,改善患者生活质量,延长生存期。

支架置入术治疗鼻泪管阻塞的长期疗效

目的 探讨鼻泪管阻塞聚氨酯支架置入术治疗方法的安全性及可行性 ,并评价其长期疗效。方法 对 5 3例 (6 4只眼 )鼻泪管阻塞患者行聚氨酯支架置入术 ,术前及术后行泪道造影检查。术后平均随访 4 8.3个月 (13～ 78个月 ) ,观察支架长期放置及取出后鼻泪管的通畅情况。结果 6 4只眼中 ,6 2只眼成功置入支架 ,技术成功率 96 .9% ,未发生严重并发症。术后 1年随访 ,支架通畅率为 76 .8% ,3及 5年时分别降至 33.3%和 2 8.6 %。 9枚完全阻塞的支架被取出 ,其中 4枚发现有增生的组织 ,5枚有黏液样物质 ,2侧鼻泪管在支架取出后造影通畅 ,另 2侧再次置入支架后通畅 ,但均于 6个月内发生再阻塞。结论 鼻泪管支架置入术简单、安全 ,可以门诊治疗 ,但长期通畅率较低 ,支架取出后再阻塞发生率高。

经皮肝穿刺胆道内支架置入术治疗恶性梗阻性黄疸

目的：回顾性分析介入性经皮肝穿刺胆道内支架置入术治疗恶性梗阻性黄疸的技术与疗效。方法：对２９例患者采用经皮肝穿刺胆道内支架置入术治疗恶性梗阻性黄疸。胆道梗阻部位位于胆总管９例、肝总管１１例，左右肝管汇合部９例。结果：２９例共置入金属内支架３６枚，其中７例置入２枚。术后１周复查血清生化指标，总胆红素（ＴＢＩＬ）从术前的（４８３．７±１９１．８）μｍｏｌ／Ｌ降至（２２１．３±１３１．７）μｍｏｌ／Ｌ（Ｐ＜０．００１），碱性磷酸酶与丙氨酸转氨酶均下降明显（Ｐ均＜０．００１）。３例于术后１个月内死亡，均与胆道引流无直接因果关系。术后１个月，３项血清生化指标均有更为显著的下降。跟踪随访２３例，平均随访６．０个月，８例仍存活。随访期内１４例（６０．９％）ＴＢＩＬ降至正常范围；８例（３４．８％）ＴＢＩＬ下降至术前的半数以下。结论：经皮肝穿刺胆道金属内支架置入术是对恶性梗阻性黄疸的一种安全、有效的姑息性治疗方法，可明显缓解黄疸，改善肝脏功能，提高生存质量，并可有限地延长生存时间。

经皮肝穿刺胆道腔内射频消融联合支架植入治疗恶性梗阻性黄疸(附2例报告)

目的探讨经皮肝穿刺胆道腔内射频消融(RFA)联合支架植入治疗恶性梗阻性黄疸的安全性和疗效。方法对2例恶性梗阻性黄疸患者在行经皮肝穿刺胆道引流术后,行经皮胆道腔内RFA联合支架植入术,观察并发症、疗效及术后50 d支架通畅情况。结果 2例患者均成功接受手术治疗,技术成功率100%。均行分段RFA,术后血清总胆红素水平显著下降。均无胆道出血、胆管穿孔、胆漏等严重并发症发生,随访50 d月支架通畅。结论经皮肝穿刺胆道腔内射频消融联合支架植入作为恶性梗阻性黄疸介入治疗的新方法,是安全及有效的,但仍需有效的随机对照试验来证实。

多支胆管梗阻的介入性引流技术

目的 探讨多支胆管梗阻介入性引流的方法及疗效。方法 2 1例多支胆管梗阻的患者根据不同情况 ,分别采用左右肝管同时植入支架内引流 (13例 )、左右肝管间植入支架经右肝管外引流(3例 )、右肝管支架内引流并左肝管外引流 (3例 )和右前叶肝管支架内引流并右后叶肝管外引流及左肝管内引流或外引流 (2例 )等内外引流技术进行治疗。结果 2 1例患者共植入胆道内支架 36枚 ,其中 35枚支架起到良好的内引流作用 ,1枚因位置不良无内引流作用。 19例患者胆道引流充分 ,黄疸完全消退。 2例患者黄疸未完全消退。结论 多种方式的胆道内外引流技术对大部分多支胆管梗阻患者治疗效果显著 ,值得进一步推广应用。

胆道支架置入术治疗胆道恶性梗阻

目的:评价胆道支架置入术治疗胆道恶性梗阻的价值。方法:135例胆道恶性梗阻患者,应用经皮肝穿胆道造影及支架置入技术,其中87例合并动脉内化疗或化疗栓塞术,48例单纯应用支架置入术。结果:单支置入128例,双支置入7例。支架置入术成功率为99.3%(成功植入142支/首次预计植入143支)。黄疸完全缓解率86.7%(117/135),总有效率97.8%(132/135)。6个月、12个月及24个月生存率分别为71.1%(96/135)、43.7%(59/135)及11.9%(16/135),联合抗肿瘤治疗与单纯支架治疗12个月生存率分别为:54.0%(47/87)及25.0%(12/48),统计学处理有显著性差异(χ2=10.59,P<0.001)。支架再狭窄或阻塞21例,经皮穿刺外引流或支架内再置入支架治疗,黄疸再次消失。结论:胆道支架置入术减黄疗效肯定,与抗肿瘤治疗联合应用可提高患者生存率。