Malignant biliary obstruction: treatment with self-expandable metallic stents

In a 3-year period, 57 self-expandable metallic biliary stents (Wallstent) were successfully placed in 49 patients with malignant biliary obstruction. Thirty-three of our patients have died. In this group follow-up was 1–12 months with a mean of 4.5 months and stent patency was 1–12 months with a mean of 4.3 months. Sixteen patients are still alive. In this group, follow-up was 2–26 months with a mean of 8.4 months and stent patency was 1–18 months with a mean of 6.8 months. In 4 patients a secondary stent was used due to malpositioning during deployment. In 1 patient bilateral drainage was achieved with two stents. Four patients required 5 reinterventions due to reocclusion, with a reocclusion rate of 9.4 %; 3 of them were treated with secondary metallic stents, 1 with a conventional stent and the remaining 1 with balloon dilatation. Thirty-day mortality rate was 8.1 % and procedure-related mortality was 2 %. Major and minor complication rates were 10 % and 22 %, respectively. Self-expandable metallic stents provide good palliation in patients with malignant biliary obstruction. Correspondence to: M. N. Özmen     

Malignant biliary obstruction: histologic findings after treatment with self-expandable stents.

Histologic analysis was performed of bile duct tissue from 15 patients who underwent treatment for malignant obstructive jaundice with a self-expandable stent. Stents were in place from 5 days to 21 months. Malignancies included adenocarcinoma of the pancreas or gallbladder or cholangiocellular, hepatocellular, or gastric carcinoma. Stents were blocked by sludge in two cases and tumor overgrowth in two others. Microscopic evaluation showed that stent placement caused complete denudation of the mucosa and mild submucosal inflammation with edema. In all but one patient, the stent was incorporated into the bile duct wall and was covered by a fibrogranulomatous tissue layer after 2 months. In some cases, an epithelium-like cell formation covered the inner surface of the stent. Tumor ingrowth was observed in two patients with poorly differentiated tumors. In stents placed for longer than 2 months, mild to moderate fibrosis and foreign body reaction were observed. Hyperplastic biliary epithelium was not found within the stent or at the stent ends.     

Malignant biliary obstruction: complications of percutaneous biliary drainage

The medical records of 161 patients who underwent percutaneous biliary drainage (PBD) for malignant biliary obstruction were reviewed with attention to the complications resulting from this mode of drainage. Observed was a higher incidence of complications--particularly of cholangitis--than that generally reported in the literature. Although PBD is an effective method of biliary drainage, it carries a high risk of cholangitis in patients with cancer, who frequently receive myelosuppressive agents that predispose them to infections.     

Malignant biliary obstruction: Treatment with self-expandable stainless steel endoprosthesis

Metal endoprostheses of the Wallstent type were successfully inserted percutaneously and endoscopically in 80 consecutive patients with malignant obstructive biliary stenoses, who were followed for up to 18 months. The indication for treatment was jaundice due to malignant biliary obstruction. Repeat radiological investigations were performed if the patient had symptoms suggesting stent occlusion. After stent implantation, 88% of patients demonstrated a serum bilirubin decrease by more than 50%. We observed a 15% rate of serious complications, including a 10% rate of cholangitis with septicemia. There were no cases of stent migration or occlusion due to encrustation of bile. Recurrent jaundice occurred in 17.5% of patients due to progressive tumor growth after 3–10 months. In 5 of these patients, tumor overgrowth was redilated and/or restented. Of the 80 patients, 34% are alive after 2–12 months (mean: 242 days); of these, two-thirds are free of jaundice. Sixty-six percent of patients died between 3 days and 1.5 years (mean: 133 days). Although autopsy investigations revealed the possibility of tumor growth onto the inner surface of the stent, through the mesh of the endoprosthesis, no stent occlusion by tumor ingrowth into the lumen occurred. Self-expandable stainless steel endoprostheses provide good palliation in patients with malignant obstructive jaundice.     

金属内支架治疗恶性梗阻性黄疸的临床研究：附33例分析

目的：总结胆管金属内支架放置术的临床经验和疗效分析。材料与方法：恶性梗阻性黄疸患者３３例，男２３例，女１０例。胆管癌１６例，胰头癌２例，原发性肝癌２例，肝转移瘤３例，肝门淋巴结转移瘤压迫胆管１０例。本组共采用金属内支架行内引流３３例，共使用６种３８枚金属内支架。１２例支架放置术后加局部放射治疗和化学治疗（简称放、化疗）。结果：３３例采用经皮经肝穿刺置入胆管支架均获得成功，其中２９例一次性植入支架，４例先行胆汁引流术（ＰＴＢＤ）后再放置金属内支架；９例因胆管梗阻复杂，金属支架置入后仍保留引流导管，其中３例在置管１５～２００天后拔除引流管。２８例（８４．８５％）黄疸消退满意。本组中位生存期７个月，支架植入后加局部放、化疗组中位生存期１０个月。结论：胆管内金属支架治疗恶性梗阻性黄疸，可用于不能手术治疗的高位胆管梗阻，支架植入后加局部放、化疗可望提高远期疗效。     

Silicone biliary stents for percutaneous management of biliary obstruction

Silicone tubes in 2-F increments from 12 to 20 F were developed for long term external-internal drainage of benign and malignant biliary obstructions. Passed coaxially over Teflon catheters and a guidewire, the silicone stents were softer and had larger sideholes than conventional drainage tubes. Once the acute track had matured (two weeks or longer), a silicone stent, 2 F larger than the preceding one, could be placed at each succeeding tube change. We have placed these tubes in 50 patients, 24 of whom had initially placed percutaneous catheters and 26 of whom had surgically placed stents. These tubes remain patent at least as long as conventional catheters and all patients have reported increased comfort using these catheters compared with standard ones.     

The use of SMARTeR stents in patients with biliary obstruction

AIM: The purpose of the study was to evaluate the percutaneous use of the new nitinol SMARTeR stents in patients with biliary obstruction. MATERIALS AND METHODS: Four stents were placed in three patients percutaneously under ultrasound and fluoroscopic guidance. RESULTS: The deployment of the stents was successful in all three patients. All stents maintained their patency and position after short-term follow-up. CONCLUSION: The nitinol SMARTeR stent is useful in the management of patients with biliary obstruction although accurate placement across the ampulla was found to be technically more difficult than with the Wallstent. Larger, long-term follow-up studies are required to evaluate the long-term patency of these new devices.     

Malignant biliary obstruction treated by wallstents and strecker tantalum stents: A retrospective review

Purpose To evaluate retrospectively the role and the effectiveness of self-expandable Wallstents and balloon-expandable Strecker stents in patients with inoperable malignant obstruction of the biliary tree. Methods Fifty patients with malignant biliary obstruction were treated from August 1991 to August 1992 by percutaneous placement of 55 metallic endoprostheses (39 Wallstents, 16 Strecker stents). All patients were followed by clinical evaluation, laboratory data, and ultrasonographic examination until death. Results Wallstent placement was successful in 36 patients without procedure-related complications. One partial occlusion after 1 year was resolved by percutaneous balloon dilatation. Fourteen patients were treated with 16 Strecker stents. Stenting was unsuccessful in four cases; four occlusions (after 6 h, 48 h, 2 and 6 months) were encountered. Conclusion Wallstent endoprostheses have good results and long-term patency. There were some problems with Strecker stents during the placement and there was a higher occlusion rate.     

Treatment of malignant biliary obstruction by percutaneous transhepatic insertion of expandable metallic stents

A group of 55 patients with jaundice secondary to malignant biliary obstruction were treated with percutaneous transhepatic insertion of self-expandable metal stents (Wallstents). Obstruction was caused by pancreatic carcinoma in 22 patients, cholangiocarcinoma in 21 patients, and other malignancies in 12 patients. A total of 16 patients were treated for hilar obstruction, 35 patients for obstruction of the bile duct below the hilum, and 4 patients for obstruction in a bilioenteric anastomosis. Stent insertion was performed as a two-step procedure in 37 patients, but as a one-step procedure in 18 patients. Adequate bile drainage was achieved in all patients. Procedure-related complications occured in 9 % of cases. After 24 months of observation time 46 patients had died (mean survival 4.6 months). The 30-day mortality rate was 5.5 %. A total of 14 patients (25.5 %) developed recurrent jaundice after an average of 5.3 (0–13) months. Percutaneous insertion of Wallstents ensures good palliation, is relatively safe, and may be performed as a one-step procedure. Correspondence to: P. Hannesson     

Malignant hilar and perihilar biliary obstruction: use of MR cholangiography to define the extent of biliary ductal involvement and plan percutaneous interventions.

PURPOSE: To determine the usefulness of magnetic resonance (MR) cholangiography in defining the extent of biliary ductal involvement in patients with malignant hilar and perihilar biliary obstruction and to evaluate whether findings at MR cholangiography alone are sufficient to plan percutaneous interventions in these patients. MATERIALS AND METHODS: Twenty-nine patients with malignant hilar and perihilar biliary obstruction were examined with MR cholangiography. Two radiologists evaluated MR images and determined the extent of biliary ductal involvement. A hypothetical plan for biliary drainage was established prior to any intervention. All patients underwent percutaneous cholangiography, and 27 of 29 patients also underwent biliary drainage and/or stent placement within 7 days after MR cholangiography. By using direct cholangiography as the standard of reference, the usefulness of MR cholangiography in defining the extent of biliary ductal involvement was determined. The type of drainage performed was compared with the type that had been anticipated at MR cholangiography. RESULTS: MR cholangiography was adequate in helping predict the extent of biliary ductal involvement in 28 (96%) of 29 patients and led to underestimation of the extent of the disease in one patient. The therapeutic plan anticipated with MR cholangiography matched the one actually used in 24 (83%) of 29 patients. CONCLUSION: The high accuracy of MR cholangiography for defining extent of ductal involvement in patients with malignant hilar and perihilar obstruction allows adequate planning of percutaneous interventions in a majority of patients.     

Metallic stents in malignant biliary obstruction

Purpose Retrospective analysis of our results with metallic stent placement for malignant biliary strictures. We sought to determine parameters that influence stent patency. Methods A total of 95 Wallstents were implanted in 65 patients (38 men, 27 women; mean age, 65.1 years) with malignant biliary obstruction. Serum bilirubin levels were assessed in 48 patients; the mean value prior to intervention was 15.0 mg/dl. Results In 12 patients (21%) complications occurred as a result of percutaneous transhepatic drainage. Stent implantation was complicated in 13 patients, but was possible in all patients. A significant decrease in bilirubin level was seen in 83.3% of patients following stent implantation. Approximately 30% of patients developed recurrent jaundice after a mean 97.1 days. In 9 patients (15%) the recurrent jaundice was caused by stent occlusion due to tumor growth. The mean follow-up was 141.8 days, the mean survival 118.7 days. Patients with cholangiocarcinomas and gallbladder carcinomas had the best results. Worse results were seen in patients with pancreatic tumors and with lymph node metastases of colon and gastric cancers. Conclusions The main predictive factors for occlusion rate and survival are the type of primary tumor, tumor stage, the decrease in bilirubin level, and the general condition of the patient.     

Flared polyurethane-covered self-expandable nitinol stent for malignant biliary obstruction

PURPOSE: To determine the technical efficacy and safety of a flared polyurethane-covered self-expandable nitinol stent in the management of malignant biliary obstruction and to evaluate its clinical efficacy by estimating stent patency and patient survival rates. MATERIALS AND METHODS: Thirteen patients with common bile duct strictures (nonhilar) caused by malignant disease were treated by placement of 13 nitinol stents. The stents used include a flared section in the proximal portion (12 mm in diameter and 10 mm in length) and a section in the remnant portion that is fully covered with high-elasticity polyurethane, with an unconstrained diameter of 10 mm and a total length of 50-80 mm. Patient survival and stent patency rates were calculated with use of Kaplan-Meier survival analysis. The follow-up bilirubin and serum amylase and lipase levels were calculated, and the differences in means were evaluated with use of a Wilcoxon signed-rank test. The average follow-up duration was 22.9 weeks (range, 8-56 weeks). RESULTS: Placement was successful in all cases. The 30-day mortality rate was 0%. The survival rates were 38% and 24% at 20 and 50 weeks, respectively. Seventy-seven percent of study patients had adequate palliative drainage during their the remainder of their lives. The stent patency rates were 71% and 48% at 20 and 50 weeks, respectively. Three patients (23%) presented with stent occlusion requiring repeat intervention. There were no procedure-related complications such as proximal or distal migration. No complications occurred other than stent occlusion. One patient's stent was removed under endoscopic guidance 15 weeks after its insertion. Bilirubin levels had significantly decreased 1 week after stent insertion (P <.001). CONCLUSION: Preliminary results suggest that placement of a flared polyurethane-covered self-expandable nitinol stent is feasible and effective in achieving biliary drainage. The stents do not migrate, but there is tumor ingrowth into the flared portion of the stent. Treatment of a larger group of patients will be mandatory to validate these long-term results.     

Polyurethane-covered self-expandable nitinol stent for malignant biliary obstruction: preliminary results

Purpose: To evaluate the immediate and long-term results in ten patients with malignant biliary obstruction using a polyurethane-covered, self-expandable nitinol stent. Methods: A nitinol stent, fully covered with high-elasticity polyurethane, with an unconstrained diameter of 10 mm and a total length of 60–80 mm, was placed transhepatically under fluoroscopic guidance in ten patients. The length of the biliary obstruction varied between 30–50 mm. The follow-up examination included a clinical assessment, serum bilirubin measurement, and ultrasound examinations at one-month intervals in all patients. Results: Initial stent deployment was successful in eight patients. Two patients experienced proximal migration, which was solved by insertion of two, uncovered Wallstents. One patient had the stent removed after two weeks because of severe nausea and vomiting. One patient had delayed migration of the covered stent after 40 weeks. The follow-up duration was 3–40 weeks (Mean: 16.9 weeks). Seven patients died (3–26 weeks) and three patients survived (24–40 weeks). The bilirubin measurements in all patients had significantly decreased one week after stent insertion. The levels of amylase and lipase had did not increase after stent insertion. Conclusions: A polyurethane-covered, self-expandable nitinol stent can be used effectively and safely in the treatment of malignant biliary obstruction. The preliminary results are favorable, but there is a need for further large studies to determine both long-term survival and patency.     

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.     

Metallic stents for treatment of benign biliary obstruction: a long-term study comparing different stents

PURPOSE: To investigate the role of metallic stents in the treatment of benign biliary strictures and analyze the differences in primary patency associated with the various types of stents deployed. MATERIALS AND METHODS: Between 1990 and 1997, 21 patients with benign obstructive jaundice were treated with transhepatic placement of metallic stents (11 Wallstents in 10 patients, nine Palmaz stents in seven patients, and four tantalum Strecker stents in four patients). Nineteen patients presented with strictures not responding to balloon angioplasty (postsurgical, n = 13; cholangitis, n = 5; unknown, n = 1). Estimates for cumulative patency, patency rate in the different stent groups, and survival were calculated with use of life-table analysis; the log-rank test was used to compare the different stent groups. The prognostic relevance of the selected variables-stent type, stent length, etiology, and location-were modeled with respect to patency according to Weibull distribution. RESULTS: The median follow-up time was 80.5 months (range, 2-116 months). The median survival time was 91 months. One patient was lost to follow-up after 3 months. Repeat intervention for recurrent obstructive jaundice was necessary in 11 patients (55%), and the median patency rate was 26 months (range, 2-96 months). The Palmaz stent was the most effective in achieving long-term patency, with a median patency duration of 36 months (range, 22-96 months), versus 9 months (range, 3-67 months) for the Wallstent and 6 months (range, 2-15 months) for the tantalum Strecker stent. The cumulative patency rate with the Palmaz stent was significantly higher than for the tantalum Strecker stent (log-rank test, P = .017) and nonsignificantly higher compared with the Wallstent (log-rank test, P = .07). Multivariate analysis showed that the type of stent (Wald test, P = .003) and stent length (Wald test, P < .0001) influenced the patency rate. CONCLUSIONS: These results suggest that the type of stent and the stent length have a significant influence on the patency rate. In this series, the Palmaz stent was most effective in achieving long-term patency in benign biliary strictures.     

经皮胆管内支架放置术并发症及发生意外情况的处理方法

目的 回顾性分析经皮肝胆管引流术和置入金属内支架过程中的17例产生并发症或发生意外情况的处理方法。方法 对64例恶性胆管梗阻的患者行经皮经肝引流和置入金属内支架术，17例发生并发症和遇到意外情况。分别为：心率减慢，血压下降5例；支架脱落在十二指肠1例；微导丝断裂2例；胆管穿孔2例；支架位置不佳3例；肝肾功能衰竭导致出血2例；交换导丝折断1例；球囊破裂导致支架移位1例。结果 5例出现心率减慢，血压下降者，对症给予药物治疗或停止操作；1例支架脱落在十二指肠（1枚）后，自动排出体外；2例穿刺胆管时微导丝断裂在肝实质内，无症状直至病故；2例胆管穿孔，采用保守治疗均无临床症状；3例支架释放后位置不佳，再置入短支架；2例肝肾衰竭患者愈后差。1例交换导丝折断在十二指肠内，经胃镜取出。1例球囊破裂导致支架移位，再置入1术支架。结论 年老体弱和高位胆管梗阻的患者，采用经皮胆管内支架放置术是安全有效的方法，但有一定难度，易出现并发症，应慎重。     

Treatment of malignant biliary obstruction with a PTFE-covered self-expandable nitinol stent.

OBJECTIVE: We wanted to determine the technical and clinical efficacy of using a PTFE-covered self-expandable nitinol stent for the palliative treatment of malignant biliary obstruction. MATERIALS AND METHODS: Thirty-seven patients with common bile duct strictures caused by malignant disease were treated by placing a total of 37 nitinol PTFE stents. These stents were covered with PTFE with the exception of the last 5 mm at each end; the stent had an unconstrained diameter of 10 mm and a total length of 50-80 mm. The patient survival rate and stent patency rate were calculated by performing Kaplan-Meier survival analysis. The bilirubin, serum amylase and lipase levels before and after stent placement were measured and then compared using a Wilcoxon signed-rank test. The average follow-up duration was 27.9 weeks (range: 2-81 weeks). RESULTS: Placement was successful in all cases. Seventy-six percent of the patients (28/37) experienced adequate palliative drainage for the remainder of their lives. There were no immediate complications. Three patients demonstrated stent sludge occlusion that required PTBD (percutaneous transhepatic biliary drainage) irrigation. Two patients experienced delayed stent migration with stone formation at 7 and 27 weeks of follow-up, respectively. Stent insertion resulted in acute elevations of the amylase and lipase levels one day after stent insertion in 11 patients in spite of performing endoscopic sphincterotomy (4/6). The bilirubin levels were significantly reduced one week after stent insertion (p < 0.01). The 30-day mortality rate was 8% (3/37), and the survival rates were 49% and 27% at 20 and 50 weeks, respectively. The primary stent patency rates were 85%, and 78% at 20 and 50 weeks, respectively. CONCLUSION: The PTFE-covered self-expandable nitinol stent is safe to use with acceptable complication rates. This study is similar to the previous studies with regard to comparing the patency rates and survival rates.