New 14-mm diameter Niti-S biliary uncovered metal stent for unresectable distal biliary malignant obstruction

AIM To investigate whether an uncovered self-expandable metal stent(UCSEMS) with a large diameter could prevent recurrent biliary obstruction(RBO).METHODS Thirty-eight patients with malignant biliary obstruction underwent treatment with an UCSEMS with a 14-mm diameter(Niti-S 14). Retrospectively, we evaluated technical and functional success rate, RBO rate, time to RBO, survival time, and adverse events in these patients.RESULTS Stent placement success and functional success were achieved in all patients. Two patients(5.3%) had RBO due to tumor ingrowth or overgrowth. The median time to RBO was 190(range, 164-215) d. The median survival time was 120(range, 18-502) d. The 6-mo non-RBO rate was 91%. Other adverse events other than RBO occurred as follows: Acute cholecystitis, post-ERCP pancreatitis, hemobilia, and fever without exacerbation of liver injury, and liver abscess in 4(10.3%), 3(7.9%), 2(5.3%), 1(2.6%), and 1(2.6%), respectively. Migration of the stents was not observed.CONCLUSION Niti-S 14 is considered to be a preferable metal stent because of a low rate of RBO with no migration.     

Single-stage EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction

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An audit of metal stent palliation for malignant biliary obstruction

BACKGROUND AND AIMS: Endoscopic stent insertion is the optimum method of palliation for malignant biliary obstruction. Metal stents have several advantages over the polyethylene alternatives, but are significantly more expensive. It has been reported that patients need to survive beyond 6 months to make metal stents more cost-effective. The aim of this study was to audit the performance of expanding metal biliary stents in our endoscopy unit, and to identify factors that might help with patient selection. METHODS: The records of all patients who were selected for endoscopic metal stent insertion at the Royal Perth Hospital for malignant biliary obstruction between September 1994 and November 1998 were reviewed. RESULTS: Thirty-two patients (16 males, mean age 71 years (range 34-88 years) were identified and followed up for a mean 201 days (range 3-810 days). Fifteen (47%) had cholangiocarcinoma, 13 (41%) had pancreatic cancer, and four had metastatic disease as the cause of obstruction. Mortality rates after metal stent insertion were 16, 41 and 55% at 30, 90 and 180 days, respectively. In total, 24 (75%) patients died during the follow-up period. Eleven (34%) stents became obstructed during follow up with a median time to occlusion of 125 days (range 44-729 days). Patients with cholangiocarcinoma had significantly longer survival than pancreatic cancer cases (median 286 vs 58 days, P = 0.04). No other factors were found to correlate with the survival or stent complications. CONCLUSIONS: Less than half of this mixed cohort survived beyond 6 months. Metal stent palliation of malignant biliary obstruction should probably be targeted at those with cholangiocarcinoma, as these patients tend to survive longer.     

New antireflux plastic stent for patients with distal malignant biliary obstruction

BACKGROUND Endoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction(MBO). However, the main problem with stent placement is the relatively short duration of stent patency.Although self-expanding metal stents(SEMSs) have a longer patency period than plastic stents(PSs), the higher costs limit the wide use of SEMSs. A PS with an antireflux valve is an attractive idea to prolong stent patency, but no ideal design for an antireflux PS(ARPS) has been proposed. We developed a new ARPS with a "duckbilled" valve attached to the duodenal end of the stent.AIM To compare the patency of ARPSs with that of traditional PSs(TPSs) in patients with unresectable distal MBO.METHODS We conducted a single-center, prospective, randomized, controlled, double-blind study. This study was conducted at the West China Hospital of Sichuan University. Consecutive patients with extrahepatic MBO were enrolled prospectively. Eligible patients were randomly assigned to receive either an ARPS or a TPS. Patients were followed by clinic visits or telephone interviews every 1-2 mo until stent exchange, death, or the final study follow-up in October 2018. The primary outcome was the duration of stent patency. Secondary outcomes included the rate of technical success, the rate of clinical success,adverse events, and patient survival.RESULTS Between February 2016 and December 2017, 38 patients were randomly assigned to two groups, with 19 patients in each group, to receive ARPSs or TPSs. Stent insertion was technically successful in all patients. There were no significant differences between the two groups in the rates of clinical success or the rates of early or late adverse events(P = 0.660, 1.000, and 1.000, respectively). The median duration of stent patency in the ARPS group was 285 d [interquartile range(IQR),170], which was significantly longer than that in the TPS group(median, 130 d;IQR, 90, P = 0.005). No significant difference in patient survival was noted between the two groups(P = 0.900).CONCLUSION The new ARPS is safe and effective for the palliation of unresectable distal MBO,and has a significantly longer stent patency than a TPS.     

One- and two-step self-expandable metal stent placement for distal malignant biliary obstruction: a propensity analysis

Background

Although self-expandable metal stents (SEMS) are widely used for distal malignant biliary obstruction, one-step SEMS (direct placement without a prior plastic stent) and two-step SEMS (placement at second endoscopic retrograde cholangiopancreatography [ERCP] following plastic stent placement) have not been fully compared.

Methods

In this multicenter retrospective study, patients were included who underwent first-time endoscopic SEMS placement between September 1994 and December 2010. We compared the one-step and two-step strategies using a propensity analysis.

Results

In total, 370 patients were identified and one-step SEMS was performed in 59 patients. After adjustment using propensity scores, the median times to dysfunction were 116 and 219?days, respectively, for one-step and two-step SEMS (P?=?0.058). Stent migration was more frequently observed in one-step SEMS as compared with two-step SEMS (25 vs. 11?%, P?=?0.031). In one-step SEMS, the number of days of hospitalization associated with first-time SEMS placement was shorter compared with that in two-step SEMS (21 vs. 30?days, P?=?0.001), and the total costs of SEMS-related interventions within 6?months were lower (6510 and 8100 USD, P?=?0.004). The pathological diagnosis rates for pancreatic and biliary tract cancer at initial ERCP were 52 and 61?%. After failed diagnosis at initial ERCP, pathological diagnosis rates for pancreatic cancer were 32 versus 76?% (P?=?0.005) by repeated ERCP versus endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA).

Conclusions

One-step SEMS was associated with increased stent migration, despite having potential cost-effectiveness. The additional yield of pathological diagnosis at repeated ERCP was low compared with that yielded by EUS-guided FNA.     

Tips and troubleshooting for transpapillary metal stenting for distal malignant biliary obstruction

Endoscopic placement of a self‐expandable metal stent (SEMS) has become a mainstream treatment to relieve non‐resectable distal malignant biliary obstructions—its longer patency and cost‐effectiveness were demonstrated in comparison with plastic biliary stents in several randomized controlled trials. Despite advances in ERCP devices and SEMSs themselves to enable safe and effective biliary drainage via a SEMS, several significant aspects of the endoscopic placement of SEMS must be considered; otherwise, SEMS‐related complications and early SEMS dysfunction may occur. Also, SEMS dysfunction, including occlusion and migration, occurs at a certain frequency in the long term, and appropriate reintervention is necessary to preserve the quality of life of the patient. Here, we present tips for endoscopic transpapillary SEMS placement for distal malignant biliary obstruction and reintervention for SEMS dysfunction.     

Risk factors for cholecystitis after metal stent placement in malignant biliary obstruction

BACKGROUND: Cholecystitis related to metal stent placement is a morbid event. OBJECTIVE: This study evaluated the risk factors of cholecystitis after metal stenting for malignant biliary obstruction. PATIENTS: Between December 1997 and April 2003, 155 patients who were treated with a metal stent for malignant biliary obstruction were retrospectively enrolled. MAIN OUTCOME MEASUREMENTS: The incidence and characteristics of patients with cholecystitis were evaluated and compared with those of patients without cholecystitis. Patient characteristics and tumor or procedure-related data were recorded for the following variables: sex, age, tumor and stent length, stent type (covered vs uncovered), cholangitis before ERCP, degree of gallbladder filling with contrast medium during ERCP, primary disease type (Klatskin vs others), presence of gallbladder stones, and the relationship of the cystic duct orifice to the location of the tumor (across vs others). RESULTS: There were 15 (9.7%) patients diagnosed with cholecystitis after metal stent insertion. The onset of cholecystitis was on average 4.6 days (range 1 to 26) after the procedure. We found that an obstruction across the cystic duct orifice by tumor (P < .01, odds ratio 12.7) and the presence of gallbladder stone (P = .01, odds ratio 6.6) were positively related to the cholecystitis after metal stent insertion. LIMITATIONS: The limitations of the study were the use of multiple types of stents and the retrospective design. CONCLUSIONS: This study demonstrated that an obstruction across the cystic duct by tumor and the presence of gallbladder stone were risk factors for the development of cholecystitis after metal stent placement.     

Efficacy of the Za self-expandable metal stent for palliation of malignant biliary obstruction

BACKGROUND: The efficacy and safety of the uncoated self-expandable Za metal stent for palliation of malignant distal biliary obstruction was prospectively analyzed. METHODS: Twenty-one patients with unresectable malignant tumors involving mid to distal common bile duct who presented with obstructive jaundice underwent endoscopic implantation of an uncoated self-expandable metal stent. Technical success with stent placement, adverse events, patient survival, duration of stent patency, and device performance were analyzed. RESULTS: Endoscopic biliary stenting was successful in all patients. No adverse events were encountered. The mean follow-up period of the 21 patients was 128 days (range, 3-263): 14 died of progressive disease at mean of 81 days (range, 3-210), 3 remain alive (at days 239, 250, and 263), and 4 were lost to follow-up (at days 90, 91, 92, and 116). The mean duration of stent patency was 249 days. Tumor ingrowth was observed in one patient (5%). Minor technical problems were encountered in 3 patients: 1 proximal deployment, 1 distal deployment, and difficulty associated with the delivery system in 1. CONCLUSIONS: The Za-metal stent provided effective palliation for patients with inoperable malignant biliary tumors. Although minor technical problems were encountered with stent deployment, the overall stent patency, efficacy, and safety profile appear satisfactory.     

Drug-eluting stent in malignant biliary obstruction

Introduction

In unresectable malignant bile duct obstruction, endoscopic stent insertion is the treatment of choice. However, the current stent allows only mechanical palliation of the obstruction, and has no anti-tumor effect. Currently, in the vascular field, the drug-eluting stent (DES) is very highly favored.

Material and methods

The requirements for a DES in a non-vascular tract, such as the bile duct, are far different from those of a DES to be used in the vascular tract. The non-vascular DES must suppress tumor proliferation as well as mucosal hyperplasia. For example, the non-vascular stent might be covered with a membrane that gradually releases a chemo-agent. We do not have much experience with DES in the bile duct. Nonetheless, we are continuously testing many anti-tumor agents in animal and human studies.

Conclusion

We expect and hope DES will work effectively for tumor cells in diverse ways and, more importantly, will prolong stent patency and the patients’ survival periods. But considerable investigation and a clinical study of DES will be required to achieve these goals.     

经皮肝穿刺胆道内支架植入治疗恶性胆道梗阻64例

目的：总结经皮肝穿刺胆道内支架植入治疗恶性梗阻性黄疸的经验，探讨其临床疗效及价值。方法：64例患者均采用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疽。根据梗阻部位的不同解剖决定放置支架的方式。结果：64例患者中，50例植入单支支架于肝总管或(和)胆总管，14例植入2支以上支架于总管和分支胆管，其中2例肝内胆管支架的桥接通过肝实质。58例患者2周内血清胆红素降低75％以上。结论：经皮肝穿刺刺内支架植入是治疗恶性胆道梗阻性的有效方法。     

Endoscopic ultrasound-guided biliary drainage with placement of a fully covered metal stent for malignant biliary obstruction

AIM: To determine the utility of endoscopic ultrasound-guided biliary drainage (EUS-BD) with a fully covered self-expandable metal stent for managing malignant biliary stricture.METHODS: We collected data from 13 patients who presented with malignant biliary obstruction and underwent EUS-BD with a nitinol fully covered self-expandable metal stent when endoscopic retrograde cholangiopancreatography (ERCP) fails. EUS-guided choledochoduodenostomy (EUS-CD) and EUS-guided hepaticogastrostomy (EUS-HG) was performed in 9 patients and 4 patients, respectively.RESULTS: The technical and functional success rate was 92.3% (12/13) and 91.7% (11/12), respectively. Using an intrahepatic approach (EUS-HG, n = 4), there was mild peritonitis (n = 1) and migration of the metal stent to the stomach (n = 1). With an extrahepatic approach (EUS-CD, n = 10), there was pneumoperitoneum (n = 2), migration (n = 2), and mild peritonitis (n = 1). All patients were managed conservatively with antibiotics. During follow-up (range, 1-12 mo), there was re-intervention (4/13 cases, 30.7%) necessitated by stent migration (n = 2) and stent occlusion (n = 2).CONCLUSION: EUS-BD with a nitinol fully covered self-expandable metal stent may be a feasible and effective treatment option in patients with malignant biliary obstruction when ERCP fails.     

Safety and efficacy of metallic stent for unresectable distal malignant biliary obstruction in elderly patients

AIM To study the safety of insertion of metallic stents in elderly patients with unresectable distal malignant biliary obstruction.METHODS Of 272 patients with unresectable distal malignant biliary obstruction, 184 patients under the age of 80 were classified into Group A, and 88 subjects aged 80 years or more were classified into Group B. The safety of metallic stent insertion, metal stent patency period, and the obstruction rate were examined in each group.RESULTS In Group B, patients had a significantly worse per-formance status, high blood pressure, heart disease, cerebrovascular disease, and dementia; besides the rate of patients orally administered antiplatelet drugs or anticoagulants tended to be higher(P 0.05). Metallic stents were successfully inserted in all patients. The median patency period was 265.000 ± 26.779(1-965) d; 252.000 ± 35.998(1-618) d in Group A and 269.000 ± 47.885(1-965) d in Group B, with no significant difference between the two groups. Metallic stent obstruction occurred in 82 of the 272(30.15%) patients; in 53/184(28.80%) patients in Group A and in 29/88(32.95%) of those in Group B, showing no significant difference between the two groups. Procedural accidents due to metal stent insertion occurred in 24/272(8.8%) patients; in 17/184(9.2%) of patients in Group A and in 7/88(8.0%) of those in Group B, with no significant difference between the two groups, either.CONCLUSION These results suggested that metallic stents can be safely inserted to treat unresectable distal malignant biliary obstruction even in elderly patients aged 80 years or more.     

Cholecystitis after metallic stent placement in patients with malignant distal biliary obstruction.

BACKGROUND & AIMS: Cholecystitis after metallic stent (MS) placement is an issue requiring attention. From our experience, cholecystitis seemed to occur mainly in patients with tumor involvement to the cystic duct orifice. The aim of the present study was to identify risk factors for cholecystitis in patients treated with covered or uncovered MS. METHODS: We analyzed 246 patients who received MS placement (covered MS in 171 and uncovered in 75) between August 1997 and May 2005 for the treatment of unresectable distal malignant biliary obstruction. Causative diseases were as follows: pancreatic cancer in 162, papillary cancer in 10, bile duct cancer in 41, and metastatic nodes in 33 patients. Tumor involvement to orifice of the cystic duct (OCD) was diagnosed based on cholangiography and intraductal ultrasonography. RESULTS: Cholecystitis after MS placement was found in 13 patients (5.3%). There was no significant difference in the incidence of cholecystitis between covered (5.8%) and uncovered (4.0%) MS. By univariate analysis, tumor involvement of the OCD, MS placed above the papilla, and stricture located at midportion were associated significantly with cholecystitis. By multivariate analysis, only tumor involvement of the OCD was a risk factor, with an odds ratio of 47.206 (95% confidence interval, 5.84-381.60). CONCLUSIONS: Cholecystitis after MS placement is associated with tumor involvement to the orifice of the cystic duct, regardless of the type of stent.