Follow-up Results of 71 Patients Undergoing Metallic Stent Placement for the Treatment of a Malignant Obstruction of the Superior Vena Cava

Purpose To retrospectively clarify the utility of metallic stent placement for the treatment of the malignant obstruction of the superior vena cava (SVC) in 71 patients with VC syndrome (SVCS) on the basis of long-term follow-up data. Materials and Methods Seventy-one patients underwent stent placement and were followed until death. The applicability of the spiral Z-stent (S-Z-stent) mainly used the initial and follow-up results, stent placement for bilateral BCV obstruction and the value of concurrent anticancer therapy were studied. Results The technical success rate was 100%, the initial clinical success rate was 87% (62/71), the primary clinical patency rate was 88% (57/65), and the secondary clinical patency rate was 95% (62/65). The obstruction rate of the stent was 12% (8/65), and an additional stent was useful for relief of recurrent SVCS. Survival of 57 patients in whom there was no recurrence of SVCS until death ranged from 1 week to 29 months (mean, 5.4 months and the S-Z-stent appeared to be suitable for the treatment of the malignant obstruction of SVC. Unilateral stent placement was effective for relief of SVCS with bilateral BCV obstruction. Patients who received concurrent anticancer therapy survived 2 months longer than those who did not. Conclusion Stent placement is an effective treatment for SVCS. Further, the utility of S-Z-stent for SVCS, an additional stent for recurrence, unilateral stent for patients with bilateral BCV obstruction, and anticancer therapy after stent placement were verified.     

Expandable metallic biliary endoprostheses: preliminary clinical evaluation

A biliary endoprosthesis constructed of self-expanding metallic "Z" stents was placed in 23 patients with obstructive jaundice. The biliary obstruction was due to a malignant neoplasm in 21 patients and a postoperative biliary stricture in two patients. The lesions affected the intrahepatic biliary ducts in 13 patients. Twelve patients had undergone radiation therapy before stent placement. The endoprostheses consisted of 196 expandable metallic biliary stents placed singly (n = 10) or in tandem (n = 186). As many as 18 stents were used to relieve an obstruction in one patient. A transhepatic approach was employed in all patients except one in whom stents were placed through a T-tube tract. Within 1 week after placement, all stents expanded to at least 90% of their original diameter. Three misplaced, two deformed, and two dislodged stents caused no obvious clinical problems. At follow-up, which ranged from 2 to 59 weeks, five patients experienced recurrent jaundice. Two patients with recurrent jaundice due to obstruction of the bile duct containing the stent were treated with external catheter drainage. The expandable biliary endoprosthesis is suggested as an effective treatment for benign and malignant biliary obstruction.     

Percutaneous Placement of Metallic Stents in Malignant Biliary Obstruction: One-Stage or Two-Stage Procedure? Pre-Dilate or Not?

The aim of this paper was to evaluate the necessity of percutaneous transhepatic catheter drainage and balloon dilation procedures performed before stent insertion. One hundred and twenty-six patients with unresectable malignant biliary obstruction underwent palliative therapy by means of percutaneous transhepatic placement of 183 metallic biliary endoprotheses. Forty-four (35%) patients underwent metallic stent insertion in a one-stage procedure and 82 (65%) had undergone percutaneous transhepatic catheter drainage before stent insertion. Balloon dilation of the stenosis before stent placement (pre-dilation) was performed in 53 (42%) of 126 patients. The rate of the 30-day mortality was 11%, with no procedure-related deaths. The total rate of early complications was 29%, and 84% of these complications were due to percutaneous transhepatic catheter drainage and pre-dilation procedures. Percutaneous transhepatic catheter drainage and pre-dilation had no clinical or statistically significant effect on the patients’ survival and stent patency rate. Percutaneous transhepatic catheter drainage and balloon dilation increased the cost of stent placement 18% and 19%, respectively. Palliation of malignant biliary obstruction with percutaneous transhepatic stent insertion should be done directly, in the simplest way, without performing percutaneous transhepatic catheter drainage and balloon dilation before stent placement. It is more useful, safe, and cost-effective.     

胆管介入与TAIC治疗恶性梗阻性黄疸的疗效分析

目的 :探讨胆管介入与动脉灌注术对于恶性梗阻性黄疸的治疗价值。材料和方法 :恶性梗阻性黄疸患者 97例。PTCD减黄术后 3 4例留置了内支架 ,45例行TAIC。比较治疗前后血清胆红素变化 ;支架组和无支架组、TAIC组和未 (N)TAIC组生存时间与生存率差别。结果 :治疗后血清胆红素明显下降 ,全部病例平均生存时间 11.1个月。支架组平均生存时间为 15 .4个月 ,无支架组平均生存时间为 8.8个月。TAIC组平均生存时间为 15 .2个月 ,而NTAIC组平均生存时间为 7.5个月。结论 :充分引流后的内支架留置术优于单纯引流术 ,而胆管介入配合TAIC能够延长生存期。     

Separate支架在治疗胃十二指肠恶性梗阻中的应用

目的 探讨Separate支架置入术在姑息性治疗不能手术的胃肠道恶性梗阻的可行性和有效性。方法 34例患者采用经口置入Separate支架治疗不能手术的恶性胃十二指肠梗阻。梗阻的原因分别是胃癌11例、胰腺癌12例、转移性肿瘤3例、胆道肿瘤6例和十二指肠癌2例。透视下分别将Separate支架的外层带膜支架和内层裸支架同轴重叠释放在狭窄病变处。结果 技术成功率为97％，未发生严重并发症。33例患者胃肠道梗阻症状缓解或消失，在Separate支架置入后，患者进食能力评分平均从3．8提高到1．2。随访期间未发现支架移位和肿瘤内生性生长等并发症，l例患者由于肿瘤浸润致支架近端梗阻复发，置入第2枚支架。结论 经口途径置入Separate支架姑息性治疗不能手术的胃十二指肠恶性梗阻是可行的和有效的。     

Palliation of malignant bile duct obstruction with metallic biliary endoprostheses: technique, results, and complications.

Expandable metallic stents were placed in 34 patients with pathologically proved malignant bile duct obstruction to determine ease of insertion, benefits of a one-stage insertion, and cost-effectiveness relative to conventional plastic stents. Thirty-eight strictures, ranging in length from 1 to 7 cm (mean, 3.2 cm), were present in the 34 patients. Strictures were located in the lower common bile duct (n = 22), middle of the common bile duct (n = 6), and hilar confluence (n = 10). In 13 patients (38%) metallic stents were placed at the time of initial biliary drainage (one-stage procedure), while the remaining patients underwent stent placement within 1-7 days of biliary drainage (two-stage procedure). Biliary obstruction was relieved in 31 of 34 patients (91%). Three patients died within 14 days of stent insertion of unrelated causes, without any change in biliary status. Mean duration of follow-up for all patients was 5.3 months (range, 0.5-14 months). Four episodes of stent occlusion occurred in three patients (12% occlusion rate); each episode was treated successfully. The average length of hospital stay for patients who underwent a one-stage procedure was 13 days (range, 3-33 days) and was 20 days (range, 9-42 days) for patients who underwent a two-stage procedure. The facility of one-step insertion, low occlusion rate, and the many strategies available for treatment of occluded stents make metallic stents an attractive alternative to conventional plastic stents in palliating patients with malignant biliary obstruction.     

经皮穿肝经口腔双途径联合支架置入治疗胆管和十二指肠恶性梗阻

目的:探讨胆管和十二指肠恶性梗阻双途径联合支架置入介入治疗的方法和效果.方法:23 例胆管和十二指肠恶性梗阻,17例先经皮肝穿刺置入金属支架解除胆管梗阻,出现十二指肠梗阻后,再在X线透视下,经口腔置入记忆合金网状十二指肠内支架.6例因胆管与十二指肠恶性梗阻并存,先置入十二指肠内支架并同时置入胆管支架.测定术前、术后血清总胆红素水平及体重并进行t检验.结果:23例患者双途径联合支架置入成功后,术前、术后血清总胆红素水平及体重比较差异均有显著性意义(P＜0.05).十二指肠支架置入后,消化道梗阻症状迅即解除,当日即能进食,均无严重并发症发生.随访1～20个月进食情况均良好.结论:经皮肝穿经口腔双途径联合支架置入治疗胆管和十二指肠恶性梗阻是首选的有效治疗方法.     

经皮肝胆管穿刺金属内支架植入治疗恶性梗阻性黄疸

目的：探讨经皮肝胆管穿刺金属内支架植入治疗恶性梗阻性黄疸临床应用价值。方法：108例患者中的9r7例均采用X线透视下经皮肝穿刺胆道内支架植入术治疗恶性梗阻性黄疸。根据梗阻部位的不同解剖决定放置支架的方式。结果：108例患者中,90例植入单支支架于肝总管或（和）胆总管,7例植入2支以上支架于总管和分支胆管,11例行外引流。全部患者2周内血清胆红素从（436±314）mol／L降低到（53±31）mol／L。结论：经皮肝穿刺内支架植入是治疗恶性胆道梗阻性的有效方法。     

Percutaneous unilateral placement of biliary covered metallic stent in patients with malignant hilar biliary obstruction and contralateral portal vein occlusion

Background Unilateral biliary metallic stent placement in the lobe with patent portal vein seemed to be a safe and effective palliative treatment of patients with contralateral portal vein occlusion caused by advanced hilar malignancy, obviating bilateral stent placement in these patients, because the hepatic lobe with portal vein occlusion ceases to produce bile due to interruption of enterohepatic circulation. Purpose To investigate the safety and efficacy of percutaneous unilateral expanded polytetrafluoroethylene (ePTFE)-covered stent placement in malignant hilar biliary obstruction with contralateral portal vein occlusion. Material and Methods From February 2008 to March 2011, 24 consecutive patients with malignant hilar biliary obstruction and unilobar portal vein occlusion were enrolled in this prospective study. All patients were treated by percutaneous placement of ePTFE-covered stents. Results Stent deployment was technically successful in all patients. Two (8%) patients experienced minor self-limiting hemobilia. No major complication was noted. Successful internal drainage was achieved in 22 (91.6%) patients. Mean serum bilirubin level, which was 12.5 mg/dl ± 8.4 before drainage, decreased significantly to 2.7 mg/dl ± 3.4, 1 month after stent placement (P < 0.001). Median survival was 191 days (95% CI, 94-288 days) and cumulative stent patency rates at 1, 3, 6, 9, and 12 months were 100%, 95%, 95%, 95%, and 71%, respectively. Two (8%) patients presented with stent occlusion due to sludge incrustation. Aside from two patients who had died within 30 days after stent placement, the other 22 patients demonstrated slight decrease in diameter of undrained lobe and did not experience cholangitis nor jaundice. Conclusion Unilateral placement of ePTFE-covered stent in the lobe with patent portal vein seems to be a safe and effective method for palliative treatment of patients with contralateral portal vein occlusion. In addition, ePTFE-covered stent placement can prevent tumor ingrowth without functional occlusion of segmental bile ducts.     

Percutaneous self-expanding metal stents versus endoscopic polyethylene endoprostheses for treating malignant biliary obstruction: randomized clinical trial

PURPOSE: To compare percutaneous self-expanding metal stents with conventional endoscopic polyethylene endoprostheses for treatment of malignant biliary obstruction by means of a prospective randomized clinical trial. MATERIALS AND METHODS: Patients with biliary obstruction due to inoperable primary carcinoma of the pancreas, gallbladder, or bile ducts or regional lymph node metastases were included. Evaluated outcomes included technical and therapeutic success rates, morbidity and 30-day mortality rates, hospital stay length and readmission, biliary reobstruction, and overall survival rates. Data were analyzed according to both the intention-to-treat principle and the treatment actually administered. Univariate (Kaplan-Meier method) and multivariate (Cox model) analyses were performed. RESULTS: After randomization, 28 patients were assigned to receive a percutaneous self-expanding metal stent and 26 patients to receive a 12-F endoscopic polyethylene prosthesis. The technical success rates of both implantation procedures were similar (percutaneous, 75% [21 of 28 patients]; endoscopic, 58% [15 of 26 patients]; P =.29), whereas therapeutic success was higher in the percutaneous group (71% [20 of 28 patients] vs 42% [11 of 26 patients]; P =.03). However, major complications were more common in the percutaneous group (61% [17 of 28 patients] vs 35% [nine of 26 patients]; P =.09) but did not account for differences in 30-day mortality rates (percutaneous, 36% [10 of 28 patients]; endoscopic, 42% [11 of 26 patients]; P =.83). Overall median survival was significantly higher in the percutaneous group than in the endoscopic group (3.7 vs 2.0 months; P =.02). Cox regression analysis enabled identification of placement of the percutaneous self-expanding metal stent as the only independent predictor of survival (relative risk, 2.19; 95% CI: 1.11, 4.31; P =.02). CONCLUSION: Placement of a percutaneous self-expanding metal stent is an alternative to placement of an endoscopic polyethylene endoprosthesis in patients with malignant biliary obstruction.     

Malignant biliary obstruction: percutaneous use of self-expandable stents

A total of 83 self-expandable metallic stents were placed percutaneously in 69 patients for palliation of malignant biliary obstruction. Stent diameter was 1 cm; length, 3.5-10.5 cm. Of the 41 patients with common bile duct obstruction, 27 died 0.2-12 months (median, 3.2 months) after stent insertion. Two patients developed recurrent jaundice and cholangitis after 6 and 12 months, respectively. One patient underwent reintervention. Fourteen patients were alive without jaundice 1-8 months (median, 6.3 months) after stent placement. Of the 28 patients with hilar lesions, 13 died 0.7-7.6 months (median, 4.3 months) after stent placement. Fifteen were alive 1-15.5 months (median, 8.1 months) afterward. Recurrent jaundice and cholangitis were seen in eight of the 28 patients (28%) after 1-6 months (median, 3.6 months). The cause of malfunction of the stent(s) was tumor ingrowth in one patient, tumor overgrowth at the proximal end in five patients, and overgrowth at the distal end in two patients. Reintervention was performed in five patients (18%). Stent-related complications were seen in four patients.     

左右肝管同时狭窄的高位胆管梗阻单双支架治疗的对比性研究

目的分析左右肝管同时狭窄的高位胆管梗阻病例行胆管内双支架放置治疗的临床应用价值。资料与方法29例肝门部胆管梗阻患者,单支架放置13例,双支架放置16例。结果单、双支架放置成功率分别为100％、93．75％（P〉0．05）;术后胆红素下降率分别为58．10％、74．63％（P〈0．05）;6个月、1年的生存率分别为78．82％、38．43％和88．17％、45．16％（P〈0．05）;并发症发生率为19．77％、23．10％（P〉0．05）。结论左右肝管同时狭窄的高位胆管梗阻,双支架放置治疗比单支架放置治疗能更有效地解除黄疸,延长生存期,值得临床推广应用。     

Percutaneous self-expandable uncovered metallic stents in malignant biliary obstruction. Complications,follow-up and reintervention in 154 patients

Purpose:
Evaluation of technique, complications and the long-term follow-up data of 154 patients with inoperable malignant biliary obstruction who underwent percutaneous placement of metallic stents. Material and Methods:
During a 6-year period, 224 self-expanding metallic stents (150 biliary Wallstents and 74 Memotherm nitinol stents) were inserted in 154 patients with inoperable malignant biliary obstruction. 100 patients had obstructions at the proximal (supracystic) level, and 54 at the distal (infracystic) level. The causes of obstructions were hilar cholangiocarcinoma (n = 64), pancreatic carcinoma (n = 34), gallbladder carcinoma (n = 24), metastatic carcinoma (n = 21), common bile duct carcinoma (n = 8), and hepatocellular carcinoma (n = 3). A complete follow-up was available for all patients. Results:
The 30-day mortality was 9%, with no procedure-related deaths. The clinical success rate within the first 30 days was 88%. The total rate of early, procedure-related complications was 28%, and half of them were due to the percutaneous transhepatic catheter drainage procedure. Recurrent jaundice occurred in 28 (18%) patients and in 23 (82%) of these, reinterventions were made in order to relieve reobstructions. The mean length of survival for the entire patient group was 4 months, while the mean period of patency for all stents was 6 months. We found no statistically significant difference in patient survival or stent patency periods in regard to the level and cause of obstruction. Conclusion:
Percutaneous metallic stent placement maintains equal palliation in patients with proximal and distal malignant biliary obstructions caused by any tumor type. Most of the early complications were due to procedures performed before stent insertion and could be decreased by direct stent insertions. The most common late complication, reobstruction, is inevitable but can be easily treated in the majority of patients.     

Subacute and chronic benign superior vena cava obstructions: endovascular treatment with self-expanding metallic stents.

OBJECTIVE: Our purpose is to report our clinical experience with patients who underwent endovascular treatment with Wallstents for subacute or chronic benign obstruction of the superior vena cava (SVC). SUBJECTS AND METHODS: Twelve patients who were an average of 54 +/- 12 years old were referred for treatment of severe SVC syndrome related to implanted central venous catheters (n = 8), postradiation fibrosis (n = 2), a permanent pacemaker (n = 1), or a benign tumor (n = 1). Symptoms were present for an average of 16 weeks (range, 4-48 weeks) before treatment. Diagnosis of SVC obstruction was confirmed with helical CT and pretherapeutic phlebography. Four patients had Stanford's type II stenosis; two, type III; and six, type IV. The mean clinical and radiologic follow-up intervals were 11 months (range, 1-36 months) and 7 months (range, 1 week to 32 months), respectively. RESULTS: Recanalization was successful in all patients. Fifteen stents were implanted in the 12 patients. Stents were placed after percutaneous balloon angioplasty in nine patients, and primary stent placement was attempted in three patients. We immediately achieved a satisfactory SVC diameter in all patients, whose symptoms were relieved completely within 1 week of stent placement. No technical or clinical complications occurred. SVC syndrome recurred in one patient 2 months after stent placement and was treated by placing a second stent. CONCLUSION: Endovascular treatment with stent placement should be considered relevant and safe for refractory benign SVC syndrome. However, a larger series and a longer follow-up period are needed to define the role of stent placement for this syndrome.     

Percutaneous hepaticoneojejunostomy and choledochocholedochal reanastomosis using metallic stents: Technical note

A new, nonsurgical approach to biliary duct reconstruction in two high-operative risk patients is presented. The first patient with an obstructed hepaticojejunostomy underwent such reconstruction by placement of Wallstent, which remained patent 9 months until death from recurrent tumor. The second patient with an inadvertently ligated common bile duct underwent a combined percutaneous transhepatic-retrograde endoscopic reconstruction with placement of a Gianturco-Rösch (GR) stent. Because of occlusion by granulation tissue 5 months later, a new GR stent covered with a silicone membrane was placed within the initial stent. Nine months after the second GR stent placement there is no evidence of obstruction.     

胆道支架与十二指肠支架联合应用治疗胆道消化道梗阻

目的评价联合应用双支架治疗胆道及十二指肠梗阻的疗效。方法20例患者实施治疗。16例患者先经过经皮肝穿刺置入胆道支架解决胆道梗阻,患者出现十二指肠梗阻的症状后,14例患者经口腔、2例患者经胃造瘘口置入十二指肠支架。有4例患者同时有胆道和十二指肠梗阻的症状,同时置入胆道和十二指肠支架。结果所有患者都成功置入了双支架,没有出现并发症和再梗阻的表现。生存期1~14个月,平均5个月。结论联合双支架置入是治疗胆道和十二指肠梗阻的有效的方法。     

Percutaneous Metallic Stent Placement in Patients with Cancer Recurrence at Bilioenterostomy Site

PurposeTo investigate the outcomes of percutaneous metallic stent placement in patients with malignant bilioenterostomy obstruction and to assess the risk factors influencing stent patency.Materials and MethodsFrom August 2008 to January 2012, 53 patients with malignant bilioenterostomy obstructions were treated with percutaneous placement of biliary metallic stents; this included expanded polytetrafluoroethylene (ePTFE)–covered stent placement in 36 patients and uncovered stent placement in 17 patients.ResultsA total of 75 stents were successfully placed in 53 patients. No major complications occurred in any patients, and minor complications occurred in nine patients (17%). The mean serum bilirubin level, which was 3.6 mg/dL ± 0.7 before drainage, decreased significantly to 2.5 mg/dL ± 0.4 at 1 month after stent placement (P = .041). Successful internal drainage was achieved in 44 of the 53 patients (83%). Kaplan–Meier analysis showed a median overall survival time of 145 days (95% confidence interval, 100–190 d), a median stent patency time of 313 days (95% confidence interval, 46–580 d), and cumulative stent patency rates at 1, 3, 6, 9, and 12 months of 91%, 75%, 64%, 56%, and 45%, respectively. Multivariate Cox regression analysis showed that the use of uncovered stents (odds ratio, 2.924; P = .033) was the only significant independent factor associated with stent occlusion.ConclusionsPercutaneous metallic stent placement is a safe and effective method for the treatment of patients with malignant bilioenterostomy obstruction. Moreover, as uncovered stent placement is the only significant independent factor associated with stent occlusion, ePTFE-covered stent placement is preferable in these patients.     

射频消融导管联合支架介入治疗恶性梗阻性黄疸的临床研究

目的探讨经皮肝穿刺胆道腔内射频消融（RFA）联合支架介入治疗恶性梗阻性黄疸的效果及安全性。 方法纳入无法行手术切除的恶性梗阻性黄疸患者共13例,均接受经皮肝穿刺胆道腔内RFA联合支架植入术,观察手术并发症、黄疸缓解情况并密切随访术后1、3、6个月的支架畅通情况及生存时间。 结果所有患者均成功接受手术治疗,术后无胆道穿孔、胆漏、胆汁性腹膜炎等严重并发症发生,术后1周,患者血清总胆红素水平较术前显著降低[（95.4±83.0）μmol/L vs. （196.4±148.4）μmol/L, t=5.156,P<0.01],黄疸缓解率为61.5%。随访术后1个月、3个月支架通畅率均为100%,6个月支架通畅率为80%（8/10）。1个月存活率为100%（13/13）,3个月存活率为92%（12/13）,6个月存活率为77%（10/13）,其中2例分别于65 d、132 d后死于晚期肿瘤严重消耗,1例97 d后死于弥散性血管内凝血。2例患者在术后4~5个月内黄疸复发,再次行RFA并重新放入金属支架。 结论联合支架植入治疗在短期内能有效且安全地延长恶性梗阻性黄疸患者胆道支架通畅时间及无症状生存时间,其远期疗效尚需进一步探讨。     

国产镍钛支架治疗恶性胆道梗阻的临床分析

目的:探讨经皮肝穿胆道植入国产镍钛支架治疗恶性梗阻性黄疸的价值和临床效果。方法:在X线监视下,22例恶性梗阻性黄疸患者经皮肝穿植入国产镍钛合金自膨式裸支架24枚,恶性梗阻的原因分别为胆管细胞癌8例,胰头癌6例,肝癌3例,壶腹癌2例,肝门转移性病变3例。结果:22例患者共24枚支架全部成功植入,术后21例患者症状缓解,总胆红素明显降低。1例患者术后1天出血死亡,30天生存率为95.5%.4个月和7个月后分别有3枚支架堵塞,通过支架内支架和钢丝疏导解除。结论:国产镍钛合金自膨式裸支架性能良好,临床疗效满意。     

Management of malignant biliary obstruction: Technical and clinical results using an expanded polytetrafluoroethylene fluorinated ethylene propylene (ePTFE/FEP)-covered metallic stent after 6-year experience

To evaluate the efficacy and safety of an expanded polytetrafluoroethylene-fluorinated ethylene-propylene (ePTFE/FEP)-covered metallic stent in the management of malignant biliary obstruction. Eighty consecutive patients with malignant common bile duct strictures were treated by placement of 83 covered metallic stents. The stent-graft consists of an inner ePTFE/FEP lining and an outer supporting structure of nitinol wire. Clinical evaluation, assessment of serum bilirubin and liver enzyme levels were analyzed before biliary drainage, before stent-graft placement and during the follow-up period at 1, 3, 6, 9 and 12 months. Technical success was obtained in all cases. After a mean follow-up of 6.9±4.63 months, the 30-day mortality rate was 14.2%. Survival rates were 40% and 20.2% at 6 and 12 months, respectively. Stent-graft patency rates were 95.5%, 92.6% and 85.7% at 3, 6 and 12 months, respectively. Complications occurred in five patients (6.4%); among these, acute cholecystitis was observed in three patients (3.8%). A stent-graft occlusion rate of 9% was observed. The percentage of patients undergoing lifetime palliation (91%) and the midterm patency rate suggest that placement of this ePTFE/FEP-covered stent-graft is safe and highly effective in achieving biliary drainage in patients with malignant strictures of the common bile duct.