Endoscopic Bilio-Duodenal Bypass: Outcomes of Primary and Revision Efficacy of Combined Metallic Stents in Malignant Duodenal and Biliary Obstructions

Background

Self-expandable metal stents (SEMSs) can be used for palliation of combined malignant biliary and duodenal obstructions. However, the results of the concomitant stent placement for the duration of the patients’ lives, as well as the need for and efficacy of endoscopic revision, are unclear.

Aim

This study evaluated the clinical effectiveness of SEMS placement for combined biliary and duodenal obstructions throughout the patients’ lives and the need for endoscopic revision.

Methods

This study is a retrospective multicenter study of 50 consecutive patients who underwent simultaneous or sequential SEMS placement for malignant biliary and duodenal obstructions. The data were collected to analyze the sustained relief of obstructive symptoms until the patients’ death and the efficacy of endoscopic revision, as well as stent patency, adverse events, survival and prognostic factors for stent patency.

Results

Technical and immediate clinical success was achieved in all of the patients. Duodenal stricture occurred before the papilla in 35 patients (70 %), involved the papilla in 11 patients (22 %) and was observed distal to the papilla in four patients (8 %). Initial biliary stenting was performed endoscopically in 42 patients (84 %) and percutaneously in eight patients. After combined stenting, 30 patients (60 %) required no additional intervention until the time of their death. The remaining 20 patients were successfully treated using endoscopic stent reinsertion: nine patients needed biliary revision, three patients needed duodenal restenting and eight patients needed both biliary and duodenal reinsertion. The median duodenal stent patency and median biliary stent patency were 34 and 27 weeks, respectively. The median survival after combined stent placement was 18 weeks. A Cox multivariate analysis showed that duodenal stent obstruction after combined stenting was a risk factor for biliary stent obstruction (hazard ratio 6.85; 95 % confidence interval 1.43–198.98; P = 0.025).

Conclusions

Endoscopic bilio-duodenal bypass is clinically effective, and the majority of the patients need no additional intervention until their death. Endoscopic revision is feasible and has a high success rate.     

Endoscopic bilateral metallic stenting for malignant hilar obstruction using newly designed stents

Background/Purpose

Whether unilateral or bilateral drainage should be performed for malignant hilar biliary obstruction is controversial. Moreover, endoscopic placement of bilateral metallic stents is difficult and complicated.

Methods

New metallic stents, such as the Niti-S Y-type stent (Y-stent), BONASTENT M-Hilar, and Niti-S large cell D-type stent (LCD), have recently been developed for bilateral stent-in-stent procedures to facilitate contralateral stent deployment through the interstices of the first metallic stent. We review the features and efficacy of these metallic stents designed for bilateral drainage in patients with hilar biliary obstruction.

Results

The newly designed stents examined exhibited high technical success rates, low stent-related complications, and good stent patency. Endoscopic reinterventions for occluded stents could be performed easily, particularly in patients with bilateral LCD placement.

Conclusion

Endoscopic bilateral stenting using newly designed metallic stents is feasible, safe, and effective in patients with unresectable malignant hilar biliary obstruction.     

Transmural Biliary Drainage Can Be an Alternative to Transpapillary Drainage in Patients with an Indwelling Duodenal Stent

Background

Self-expandable metal stents (SEMS) are widely utilized to relieve symptoms of malignant gastric outlet obstruction (GOO), but GOO is frequently complicated by nonresectable distal biliary obstruction. The optimal endoscopic approach to biliary drainage in this setting remains controversial and has yet to be resolved.

Aims

To compare the safety and efficacy of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) and transpapillary drainage in patients with an indwelling duodenal SEMS.

Methods

Patients who underwent EUS-BD or transpapillary drainage for distal malignant biliary obstruction with an indwelling duodenal SEMS between June 2007 and August 2012 at three Japanese tertiary referral centers were identified retrospectively. We compared times to stent dysfunction, causes of dysfunction, and procedural related complications between these two groups.

Results

Twenty patients were included in the study (7 EUS-BD and 13 transpapillary drainage). EUS-BD was performed via hepaticogastrostomy using a SEMS in three patients and via choledochoduodenostomy using a SEMS or a plastic stent in two patients each. Transpapillary drainage was performed using a SEMS in all patients. The stent patency rate in the EUS-BD group was higher than that in the transpapillary drainage group (100 vs. 71 % at 1 month and 83 vs. 29 % at 3 months, respectively). The rate of stent dysfunction in the EUS-BD group tended to be lower than that in the transpapillary group (14 vs. 54 %; P = 0.157). Complication rates were similar between the groups (P = 1.000), with moderate bleeding in one patient in the EUS-BD group and mild pancreatitis in one patient in the transpapillary group.

Conclusion

Endoscopic ultrasound-guided transmural biliary drainage is an alternative to transpapillary drainage in patients with an indwelling duodenal SEMS.     

Treating bilio-duodenal obstruction: Combining new endoscopic technique with 6 Fr stent introducer

Periampullary cancer may cause not only biliary but also duodenal obstructions. In patients with concomitant duodenal obstructions, endoscopic biliary stenting remains technically difficult and may often require percutaneous transhepatic biliary drainage. We describe a method of metal stent placement via a thin forwardviewing endoscope in patients with simultaneous biliary and duodenal obstruction. In two consecutive patients with biliary and duodenal obstruction due to pancreatic cancer, a new biliary meta...     

Endoscopic placement of a new short-term biodegradable pancreatic and biliary stent in an animal model: a preliminary feasibility study (with videos)

Background and purpose

Recently, biodegradable pancreatic stents have been designed and placed in vivo and in vitro. The aim of this study is to investigate the feasibility of endoscopic stenting using the novel, braided, self-expandable, biodegradable, pancreatic and biliary stent in a pig model.

Methods

A braided, self-expandable, biodegradable stent was endoscopically placed into the pancreatic duct and bile duct in 4 pigs. Eventually, necropsy was performed to evaluate the stent placement after the procedure.

Results

Pancreatic and biliary stents were successfully inserted and easily deployed across the papilla into the main pancreatic duct and bile duct, respectively, in all the animals under endoscopic and fluoroscopic guidance. Necropsy performed immediate following stent placement, found that stents had been placed across the papilla and stent expansion had occurred in all cases.

Conclusions

Although this stent is not radiopaque and the number of cases was small in this experimental study, endoscopic stenting using this novel, braided, self-expandable, biodegradable, pancreatic and biliary stent was feasible in the pig model. Further animal studies to evaluate the short-term patency, tissue reactivity and degradability of the stents are warranted.     

Endoscopic biliary stent insertion through specialized duodenal stent for combined malignant biliary and duodenal obstruction facilitated by stent or PTBD guidance

Objectives: Endoscopic stenting for combined malignant biliary and duodenal obstruction is technically demanding. However, this procedure can be facilitated when there is guidance from previously inserted stent or PTBD tube. This study aimed to evaluate the feasibility and clinical success rate of endoscopic placement of biliary self-expandable metal stent (SEMS) through duodenal SEMS in patients with combined biliary and duodenal obstruction due to inoperable or metastatic periampullary malignancy.

Materials and methods: A total of 12 patients with combined malignant biliary and duodenal stricture underwent insertion of biliary SEMS through the mesh of specialized duodenal SEMS from July 2012 to October 2016. Technical and clinical success rate, adverse events and survival after completion of SEMS insertion were evaluated.

Results: The duodenal strictures were located in the first portion of the duodenum in four patients (Type I), in the second portion in three patients (Type II), and in the third portion in five patients (Type III). Technical success rate of combined metallic stenting was 91.7%. Insertion of biliary SEMS was guided by previously inserted biliary SEMS in nine patients, plastic stent in one patient, and PTBD in two patients. Clinical success rate was 90.9%. There were no early adverse events after the procedure. Mean survival period after combined metallic stenting was 91.9 days (range: 15–245 days).

Conclusions: Endoscopic placement of biliary SEMS through duodenal SEMS is feasible with high success rates and relatively easy when there is guidance. This method can be a good alternative for palliation in patients with combined biliary and duodenal obstruction.     

Technical Feasibility and Revision Efficacy of the Sequential Deployment of Endoscopic Bilateral Side-by-Side Metal Stents for Malignant Hilar Biliary Strictures: A Multicenter Prospective Study

Background

Theoretically, the side-by-side bilateral placement of metal stents may be technically easier than stent-in-stent bilateral placement in stent revision. However, side-by-side placement can be technically challenging, as the deployment of the first stent can preclude the passage of the second stent.

Aim

We explored the technical feasibility and revision efficacy of endoscopic bilateral side-by-side stent placement for malignant hilar biliary strictures.

Methods

Forty-four patients with Bismuth type II or higher malignant hilar biliary strictures were enrolled in seven academic tertiary referral centers. Endoscopic placement of side-by-side bilateral metal stents with 7F thin delivery shaft was performed. The outcome measurements were the technical and functional success, adverse events, endoscopic revision success rate, and stent patency.

Results

Overall, the technical and functional success rates were 91 % (40/44), and 98 % (39/40), respectively. Two of the failed patients were converted successfully with subsequent contralateral stent-in-stent placement, and the other patients underwent percutaneous intervention. Early stent-related adverse events occurred in 10 %. The endoscopic revision rate due to stent malfunction during follow-up (median: 180 days) was 45 % (18/40; tumor ingrowth in 4 and in-stent sludge impaction/stone formation in 14 patients). The endoscopic revision success rate was 92 % (12/13). Five patients with comorbidity underwent initial percutaneous intervention. The median survival and stent patency periods were 180 and 157 days, respectively.

Conclusions

The sequential placement of a metal stent with a 7F thin delivery shaft in bilateral side-by-side procedures may be feasible and effective for malignant hilar biliary strictures and for endoscopic stent revision.     

Efficacy of a Metallic Stent Covered with a Paclitaxel-Incorporated Membrane Versus a Covered Metal Stent for Malignant Biliary Obstruction: A Prospective Comparative Study

Background

The placement of a self-expandable metallic stent (SEMS) is a widely used nonsurgical treatment method in patients with unresectable malignant biliary obstructions but SEMS is susceptible to occlusion by tumor ingrowth or overgrowth.

Aim

The efficacy and safety of a metallic stent covered with a paclitaxel-incorporated membrane (MSCPM) in which paclitaxel provided an antitumoral effect was compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions.

Methods

Patients with unresectable distal malignant biliary obstructions (n = 106) were prospectively enrolled in this study at multiple treatment centers. A MSCPM was inserted endoscopically in 60 patients, and a CMS was inserted in 46 patients. Patients underwent systemic chemotherapy regimens alternatively according to disease characteristics.

Results

The two groups did not differ significantly in mean age, male to female ratio, or mean follow-up period. Stent occlusion due to tumor ingrowth occurred in 12 patients who received MSCPMs and in eight patients who received CMSs. Stent patency and survival time did not differ significantly between the two groups (p = 0.116, 0.981). Chemotherapy had no influence on stent patency, but gemcitabine-based chemotherapy was a significant prognostic factor for survival time (p = 0.012). Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups.

Conclusions

Although the use of a MSCPM produced no significant differences in stent patency or patient survival in patients with malignant biliary obstructions compared with the use of a CMS, this study demonstrated that MSCPM can be used safely in humans.     

Endoscopic treatment of biliary complications after right-lobe living-donor liver transplantation with duct-to-duct biliary anastomosis

Background/Purpose

The aims of this study were to characterize the features of the biliary complications that occur after right-lobe living-donor liver transplantation (RL-LDLT) with duct-to-duct biliary anastomosis, and to evaluate the efficacy of treating biliary complications endoscopically.

Methods

The records of 273 consecutive patients who underwent RL-LDLT with duct-to-duct biliary anastomosis from July 1999 through July 2005 at Kyoto University Hospital were reviewed to determine the overall incidence of postoperative biliary complications and the outcome of endoscopic repair of those complications.

Results

Biliary complications occurred in 93 (34.1%) of the patients. These complications were: 80 biliary strictures (75 anastomotic and 5 nonanastomotic) and 16 biliary leakages (5 patients with biliary leakage also had a biliary stricture); most (72%) of the anastomotic strictures were complex (i.e., fork-shaped or trident-shaped). The strictures and leakages were repaired by the endoscopic placement of multiple inside stents above the sphincter of Oddi, and by nasobiliary drainage, respectively. The procedure was successful in repairing 51 (68.0%) of the anastomotic strictures and 8 (50.0%) of the biliary leakages.

Conclusions

Endoscopic stenting of the bile ducts is efficacious in treating biliary complications related to RL-LDLT with duct-to-duct biliary anastomosis and the stenting should be attempted before surgical revision of strictures and leakages.     

Endoscopic management of laparoscopic cholecystectomy-associated bile duct injuries

Background/purpose

The efficacy of the endoscopic management of laparoscopic cholecystectomy (LC)-associated bile duct injuries is unclear because few studies on the issue report methods matched to injury type or long-term follow-up data.

Methods

Records from our institution??s 11-year experience with the endoscopic management of LC-associated bile duct injuries were reviewed. Leakage was managed with a 5- to 7F endoscopic nasobiliary drainage (ENBD) tube for 1?week without endoscopic sphincterotomy (EST). Stricture was managed with the placement of a single 7F plastic stent for 1?C2?months without EST.

Results

Fifteen cases were experienced. Of the 11 cases (77.8%) of leakage, 7 improved clinically and on imaging after ENBD, 2 did not resolve until after the placement of a single plastic 7F stent for several more days, and 2 others with leakage and high risk for accidental ENBD removal improved after the placement of a single 7F stent. All 4 cases of stricture resolved completely after the placement of a single 7F stent. There were no severe complications of the endoscopic procedure. At long-term follow-up, no patient had recurrence of symptoms or complications on imaging.

Conclusions

ENBD for leakage and biliary stenting for strictures are safe and effective treatments for these LC-associated injuries.     

Successful replacement of a metallic hepaticogastrostomy stent dislocated during endoscopic retrograde cholangiography

In the present case with lower bile duct cancer, an endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) was placed because of repeated obstructions of biliary metallic stent. However, when the HGS was occluded, transpapillary duodenoscopic procedure was again required. During this transpapillary procedure, including biliary balloon cleaning and metallic stent deployment, the HGS stent was dislocated into the stomach. Fortunately, due to the complete fistulization, no bile peritonitis was recognized and an HGS stent could be replaced from the gastric wall three days later. Current case report alarms a risk of HGS stent dislocation when conducting endoscopic retrograde cholangiopancreatography (ERCP)-associated procedures after the placement of an HGS stent.     

Endoscopic biliary drainage for children with persistent or exacerbated symptoms of choledochal cysts

Background

Symptoms of choledochal cysts sometimes persist or become exacerbated. As preoperative management for patients with these cysts, we prospectively employed endoscopic drainage, based on the theory that protein plugs cause symptoms by obstructing the pancreatobiliary ducts.

Methods

Children with choledochal cysts underwent endoscopic retrograde cholangiopancreatography (ERCP). When ERCP showed compaction with filling defects in patients with persistent or worsening symptoms (study patients), the placement of a short biliary stent tube was attempted for drainage. The clinical and ERCP findings of the study patients were compared with those of patients who were asymptomatic at ERCP (asymptomatic patients).

Results

There were 13 study patients (median age 2.9 years) and 41 asymptomatic patients (4.7 years) enrolled in the study between August 2005 and February 2011. Study patients more frequently had jaundice and elevated transaminase levels. ERCP showed that all study patients had obstruction or compacted filling defects in the common channel or the narrow segment distal to the cyst. Insertion of a stent tube was successful in 11 patients. Symptoms were relieved soon after biliary drainage. Surgery revealed that the obstructing materials were protein plugs, except in one case, which involved fatty acid calcium stones.

Conclusions

These results support the protein plug theory. Endoscopic short-tube stenting is adequate and effective as preoperative management.     

Endoscopic Biliary Sphincterotomy Is Not Required for Transpapillary SEMS Placement for Biliary Obstruction

Background  

Endoscopic retrograde cholangiopancreatography with biliary self-expanding metal stent placement is the preferred method of providing biliary drainage for pancreaticobiliary malignancies. Some endoscopists routinely perform biliary sphincterotomy to facilitate biliary stent placement and potentially minimize pancreatitis with transpapillary self-expanding metal stent placement.     

Complications of the treatment of endoscopic biliary strictures developing after liver transplantation

Background

Bile duct strictures remain a major source of morbidity after orthotopic liver transplantation (OLT). Endoscopic management by the conventional methods of biliary dilatation and/or stent placement has been successful, but sometimes severe complications occur, necessitating prolonged therapy. The aim of this study is to clarify the complications of the endoscopic approach for endoscopic dilatation and/or stent placement.

Method

Of 46 patients who underwent living-donor liver transplantation, 10 were diagnosed as having anatomic biliary strictures by endoscopic retrograde cholangiopancreatography (ERCP). Two patients developing biliary strictures after deceased-donor liver transplantation were also enrolled in the study. For the purpose of comparison, 302 patients with a total of 550 consecutive ERCP cases (including 115 patients with 250 malignant bile duct strictures) were recruited in this study. Success rate, number of endoscopy sessions, the median procedure time for ERCP, and incidence of complications including post-ERCP pancreatitis were compared in the OLT cases and other cases.

Results

The following results were obtained in the OLT cases, malignant stricture cases, and all cases, respectively: mean number of endoscopy sessions was 3.62, 2.17, and 1.94 (P?=?0.0216, P?P?=?0.0327, P?=?0.0093); and severe pancreatitis occurred in 2 cases of OLT. In a univariate analysis for post-ERCP pancreatitis, OLT was extracted as the only significant risk factor.

Conclusions

Endoscopic maneuvering for biliary dilatation and/or stent placement following OLT was associated with a higher risk of post-ERCP pancreatitis than the use of the same technique for the treatment of malignant biliary stricture. Endoscopic treatment after OLT was a significant risk factor for post-ERCP pancreatitis.     

RETRACTED ARTICLE: Preoperative endoscopic pancreatic stenting: a novel prophylactic measure against pancreatic fistula after distal pancreatectomy

Background/Purpose

The prevention of pancreatic fistula is still a major problem in distal pancreatectomy (DP). We have recently adopted preoperative endoscopic pancreatic stenting with the aim of preventing the leakage of pancreatic juice from the resection plane of the remnant pancreas after DP. We reviewed ten patients who underwent this intervention.

Methods

One to 6 days before surgery, the patients underwent an endoscopic transpapillary pancreatic stent (7 Fr., 3 cm) placement. The perioperative short-term outcomes were assessed.

Results

Preoperative endoscopic pancreatic stenting was successfully performed in all ten patients. Two (20%) patients, both with intraductal papillary mucinous tumor, developed mild acute pancreatitis after the stent placement. None of the ten patients developed pancreatic fistula. The pancreatic stent was removed 8–28 days (mean, 11 days) postoperatively.

Conclusions

Preoperative endoscopic pancreatic stenting may be an effective prophylactic measure against pancreatic fistula development following DP.

     

Endoscopic pancreatic duct drainage and stenting for acute pancreatitis and pancreatic cyst and abscess

Background/Purpose

Endoscopic drainage of pancreatic pseudocysts using transpapillary and transmural approaches has been reported. In this study, endoscopic nasopancreatic drainage (ENPD) and pancreatic stenting were performed in patients with pseudocyst and abscess associated with acute pancreatitis, and the usefulness and problems of the procedures were investigated.

Methods

After endoscopic retrograde pancreatography was done, ENPD and/or pancreatic stenting were performed in 13 patients with pancreatitis and pseudocyst or abscess that communicated with the main pancreatic duct.

Results

ENPD was performed in seven patients, and was effective in all five patients with cysts: the cysts disappeared or shrank. However, the condition in the two patients with abscess was unchanged, and percutaneous drainage was performed. Stenting was carried out in six patients, and the cyst disappeared or pancreatitis was improved in all six. The stent was removed from two patients, but no recurrence has been noted so far.

Conclusions

ENPD and stenting are effective therapeutic choices for acute and chronic pancreatitis and pseudocysts, and they are superior to percutaneous drainage to avoid pancreatic fistula, but they may not be effective for pancreatic abscess. Selection of therapeutic methods corresponding to individual cases is important.     

Covered metallic stenting for malignant distal biliary obstruction: clinical results according to stent type

Background

In the endoscopic management of unresectable malignant biliary obstructions, covered metallic stents (CMSs) showed longer patency and lower incidence of stent occlusion than uncovered metallic stents (UMCs). However, there are very few reports on factors influencing the results of inserting CMSs. We evaluated differences in clinical results according to stent type.

Methods

We reviewed the results of four types of CMS (polyurethane-covered Diamond stent (PCD), silicone-covered WALLSTENT (SCW), ComVi stent, and VIABIL biliary stent) and an uncovered MS (UMS), based on our experience and the literature. CMSs were characterized according to the axial and radial forces, covering (partial, full), smoothness of the inner surface, and presence of an anti-migration system.

Results

CMSs were patent significantly longer than UMSs. There were differences in stent patency among the CMSs, including the cause of occlusion and other complications. The PCD had good patency and a low incidence of migration. The ComVi stent occluded early due to food impaction, but had the longest median stent patency and a low migration rate. The incidence of migration of SCW was relatively high and the SCW was occluded primarily by sludge.

Conclusions

We should assess the differences between the various CMSs and select the best one for each patient.     

Preoperative biliary stents in pancreatic cancer

Background

Pancreatic cancer is a common digestive cancer with high mortality, and surgical resection is the only potential curative treatment option. Pancreatic head cancer is usually accompanied by biliary obstruction, which potentially increases surgical complications following pancreaticoduodenectomy. Thus, preoperative biliary drainage has long been advocated.

Methods

A review of the literature using Medline, Embase and Cochrane databases was undertaken.

Results

Endoscopic or percutaneous biliary stent placement is technically successful in most patients. The use of routine preoperative biliary drainage in the setting of pancreatic cancer with biliary obstruction is controversial. Prospective studies have shown that complications related to preoperative biliary drainage using endoscopic placement of traditional plastic endoprostheses increase the overall morbidity compared to pancreaticoduodenectomy alone. Placement of self-expandable metal stents could reduce stent-related complication rates such as early occlusion because of prolonged patency, especially when surgery is delayed.

Conclusion

Pancreatic cancer patients with deep jaundice and expected delay prior to curative intent surgery are potential candidates for temporary biliary drainage. Cholangitis remains a formal indication for early, urgent preoperative biliary decompression for patients with pancreatic cancer.     

Ultrasound-Guided Endoscopic Biliary Drainage: A Useful Drainage Method for Biliary Decompression in Patients with Biliary Obstructions

Background

Endoscopic retrograde cholangiopancreatography with fluoroscopy guidance is a well-established technique for providing biliary drainage in patients with biliary obstructions. However, fluoroscopic facilities may not always be available and fluoroscopy carries a risk of radiation exposure.

Aim

We retrospectively compared the procedure success rate and efficacy of ultrasound-guided endoscopic biliary drainage (UG-EBD) and fluoroscopy-guided endoscopic biliary drainage (FG-EBD) in patients with biliary obstructions.

Methods

Patients who had received either UG-EBD or FG-EBD were included in the study. Main outcome measurements included the procedure success rate, procedure time, and clinical response.

Results

A total of 125 patients who had undergone UG-EBD (n = 63) and FG-EBD (n = 62) were identified. The total procedure success rate was 93.7 % in the UG-EBD group and 96.8 % in the FG-EBD group without statistical difference. Also, no significant difference was found in the procedure success rate of lower or upper/middle obstructions of the common bile duct (CBD) between the 2 groups. The mean procedure time was not different between the 2 groups [UG-EBD group 24.54 (9.52) min vs. FG-EBD group 21.74 (8.77) min, p = 0.09]. There were no differences in the normalization of clinical and laboratory parameters and immediate complication between the 2 groups.

Conclusions

Endoscopic biliary drainage (EBD) under US-guidance and under fluoroscopy guidance is equally effective and safe for patients with lower or upper/middle obstructions of the CBD. The UG-EBD technique is especially suitable for special patients, such as critically ill patients, pregnant woman, etc.     

Management of dysfunctional covered self-expandable metallic stents in patients with malignant distal biliary obstruction

Background

Endoscopic placement of covered self-expandable metallic stents (CSEMSs) is effective for distal malignant biliary obstruction. However, management of dysfunctional CSEMSs has not been established.

Methods

Between March 1998 and July 2007, a total of 74 patients who underwent endoscopic re-interventions for CSEMS dysfunction were analyzed. Second stent insertion (CSEMS or plastic stent) or mechanical cleaning of the occluded CSEMS was performed endoscopically. The period between second stent insertion and stent dysfunction or patient death (time to dysfunction; TTD) was calculated. The cleaned initial CSEMSs were analyzed as second stents.

Results

Dysfunction of the second stent occurred in 17 of 37 patients (45.9 %) in the CSEMS group, 16 of 20 (80.0 %) in the plastic stent group, and 13 of 17 (76.5 %) in the cleaning group. The median TTD of each group was 176, 57, and 46 days, respectively. The cumulative TTD was significantly higher in the CSEMS group than in the plastic stent and cleaning groups (P = 0.08). From the multivariate analysis, sludge occlusion of the first CSEMS was identified as a significant risk factor for second stent dysfunction (HR, 2.51; 95 % CI, 1.19–5.46), and placement of the second CSEMS significantly reduced the risk of dysfunction (HR, 0.39; 95 % CI, 0.18–0.79).

Conclusions

Insertion of a new CSEMS should be considered as the treatment of choice for the management of dysfunctional CSEMSs.