A non-randomized study in consecutive patients with postcholecystectomy refractory biliary leaks who were managed endoscopically with the use of multiple plastic stents or fully covered self-expandable metal stents (with videos).

BACKGROUND: Endoscopic management of postcholecystectomy biliary leaks is widely accepted as the treatment of choice. However, refractory biliary leaks after a combination of biliary sphincterotomy and the placement of a large-bore (10F) plastic stent can occur, and the optimal rescue endotherapy for this situation is unclear. OBJECTIVE: To compare the clinical effectiveness of the use of a fully covered self-expandable metal stent (FCSEMS) with the placement of multiple plastic stents (MPS) for the treatment of postcholecystectomy refractory biliary leaks. DESIGN: Prospective study. SETTING: Two tertiary-care referral academic centers and one general district hospital. PATIENTS: Forty consecutive patients with refractory biliary leaks who underwent endoscopic management. INTERVENTIONS: Temporary placement of MPS (n = 20) or FCSEMSs (n = 20). MAIN OUTCOME MEASUREMENTS: Clinical outcomes of endotherapy as well as the technical success, adverse events, need for reinterventions, and prognostic factors for clinical success. RESULTS: Endotherapy was possible in all patients. After endotherapy, closure of the leak was accomplished in 13 patients (65%) who received MPS and in 20 patients (100%) who received FCSEMSs (P = .004). The Kaplan-Meier (log-rank) leak-free survival analysis showed a statistically significant difference between the 2 patient populations (χ(2) [1] = 8.30; P < .01) in favor of the FCSEMS group. Use of <3 plastic stents (P = .024), a plastic stent diameter <20F (P = .006), and a high-grade biliary leak (P = .015) were shown to be significant predictors of treatment failure with MPS. The 7 patients in whom placement of MPS failed were retreated with FCSEMSs, resulting in closure of the leaks in all cases. LIMITATIONS: Non-randomized design. CONCLUSION: In our series, the results of the temporary placement of FCSEMSs for postcholecystectomy refractory biliary leaks were superior to those from the use of MPS. A randomized study is needed to confirm our results before further recommendations.

Predictive value of cholangioscopy after endoscopic management of early postcholecystectomy bile duct strictures with an increasing number of plastic stents: a prospective study (with videos).

BACKGROUND: Endotherapy of postcholecystectomy bile duct stricture (PCBS) has been established as an alternative treatment to surgery. Several studies have reported conflicting results regarding the predictors of success or failure of endotherapy. OBJECTIVE: To evaluate the different cholangioscopic appearances of PCBS after endotherapy with an increasing number of plastic stents and the predictive values of these appearances for the outcome. DESIGN: Prospective study with a long-term follow-up. SETTING: Two academic tertiary referral centers. PATIENTS: Twenty consecutive patients with major bile duct injury, with a bile leak, and a PCBS who underwent therapeutic ERCP. INTERVENTIONS: Closure of the leak followed by temporary placement of multiple plastic stents for the treatment of PCBS, followed by cholangioscopy at the end of endotherapy. MAIN OUTCOME MEASUREMENTS: To analyze the predictive value of cholangioscopy, other predictors of stricture recurrence after endotherapy, and long-term clinical success. RESULTS: Closure of the leak was achieved in all patients. The median duration of endotherapy was 12 months (range 7-18 months). After endoscopic stenting, the PCBS was considered to be appropriately dilated in all patients. After endotherapy, 3 different findings were noted on cholangioscopy: (1) no lesion or minor defect (n = 10), (2) minor stricture with a fibrous ring (n = 6), and (3) presence of tissue hyperplasia (n = 4). During follow-up, stricture recurrence developed in 4 of 20 patients. All 4 patients were successfully retreated by an additional period of stenting and remained free of cholestasis after a median follow-up period of 44 months. By Kaplan-Meier (log-rank) and univariate analyses, the cholangioscopic pattern of tissue hyperplasia was significantly associated with stricture recurrence (P < .01). LIMITATIONS: Small sample size. CONCLUSIONS: Endoscopic stenting should be regarded as the primary treatment of choice because of the successful long-term outcome after 1 or more additional periods of treatment. However, the cholangioscopic pattern of tissue hyperplasia at the time of stent removal is a strong predictor of stricture recurrence, and this observation may lead to an additional period of endotherapy or other treatment modalities.

Short-term stenting using fully covered self-expandable metal stents for treatment of refractory biliary leaks, postsphincterotomy bleeding, and perforations.

BACKGROUND: Fully covered self-expandable metal stents (FCSEMS) have been used as a rescue therapy for several benign biliary tract conditions (BBC). Long-term stent placement commonly occurs, and prolonged FCSEMS placement is associated with the majority of the complications reported. This study evaluated the duration of stenting and the efficacy and safety of temporary FCSEMS placement for three BBCs: refractory biliary leaks, postsphincterotomy bleeding, and perforations. METHODS: This was a retrospective case series with long-term follow-up of 25 patients who underwent FCSEMS placement for BBCs. This study included 17 patients with postcholecystectomy refractory biliary leaks who had previously undergone unsuccessful sphincterotomy and plastic stent placement, 4 patients with difficult-to-control postsphincterotomy bleeding, and 4 patients with a perforation following endoscopic sphincterotomy. Stents were removed according to clinical evidence of problem resolution. The review included stenting duration, safe FCSEMS removal, clinical efficacy, complications, and long-term outcomes. During the follow-up period, ERCP and cholangioscopy procedures were performed to exclude the possibility of bile duct lesion development. RESULTS: Complete resolution of the initial condition was achieved in all patients. Patients with biliary leaks had a median stent duration time of 16 days (range 7-28 days). Patients with bleeding had stents removed after a median time of 6 days (range 3-15 days). Patients with perforations had their stents removed after a median time of 29.5 days (range 21-30 days). There were no complications related to stenting. CONCLUSIONS: Temporary placement of a FCSEMS for 30 days or less is an effective rescue therapy for refractory biliary leaks, difficult-to-control post-endoscopic sphincterotomy bleeding, and perforations. Duration of stenting should be different for each type of condition. Stents can be safely removed, and short-term stenting is associated with the absence of early and late complications.

Sustained relief of obstructive symptoms for the remaining life of patients following placement of an expandable metal stent for malignant colorectal obstruction.

BACKGROUND: self-expanding metal stents are currently being used as a definitive palliative treatment for malignant colorectal obstruction in patients with incurable disease. Few studies have followed large numbers of patients from stent placement until death, and those few have reported conflicting results in the long-term clinical outcome data. AIMS: this study evaluated the clinical effectiveness of stent placement for malignant colorectal obstruction throughout the patients lives and related factors affecting stent patency, clinical success and complications. METHODS: this was a multicentre, retrospective study of 89 consecutive patients who had undergone attempted expandable stent placement for symptomatic malignant colorectal obstruction during a 10-year period. Data were collected to analyse the sustained relief of obstructive symptoms throughout the patients lives, as well as the technical success, immediate clinical success, stent patency, complications, reinterventions, survival, prognostic factors associated with stent patency and long-term clinical efficacy and risk factors for complications. RESULTS: technical and immediate clinical success were achieved in 95.5% and 91.0% of patients, respectively. A total of 68 out of 89 patients (76.4%) maintained relief of obstruction from stent implantation until death without reintervention. Twenty patients (22.5%) had complications including perforation (n = 4; 4.5%), stent obstruction (n = 8; 9.0%), migration (n = 5; 5.6%) and haemorrhage (n = 3; 3.4%). Stent-related mortality was seen in 1 patient (1.1%). The estimated median survival and estimated mean stent patency were 87.0 and 322.7 days, respectively. In total, 12 of the initial 89 patients (13.5%) needed a colostomy for long-term relief of the obstructive symptoms. Univariate and multivariate analysis detected no significant prognostic factors associated with stent patency, long term clinical efficacy and risk factors for complications; however, the multivariate logistic model revealed a non-significant trend by which the use of chemotherapy was a risk factor for migration (OR = 11.89; p = 0.06). CONCLUSIONS: for palliation of incurable malignant colorectal obstruction, expandable stents can provide sustained relief of obstruction in approximately 75% of patients. The procedure is associated with acceptable morbidity, need for reintervention and minimal mortality.

Endoscopic stenting for hilar cholangiocarcinoma: efficacy of unilateral and bilateral placement of plastic and metal stents in a retrospective review of 480 patients.

BACKGROUND: Endoscopic biliary drainage of hilar cholangiocarcinoma is controversial with respect to the optimal types of stents and the extent of drainage. This study evaluated endoscopic palliation in patients with hilar cholangiocarcinoma using self-expandable metallic stents (SEMS) and plastic stents (PS).We also compared unilateral and bilateral stent placement according to the Bismuth classification. METHODS: Data on 480 patients receiving endoscopic biliary drainage for hilar cholangiocarcinoma between September 1995 and December 2010 were retrospectively reviewed to evaluate the following outcome parameters: technical success (TS), functional success (FS), early and late complications, stent patency and survival. Patients were followed from stent insertion until death or stent occlusion. Patients were divided into 3 groups according to the Bismuth classification (Group 1, type I; Group 2, type II; Group 3, type ≥ III). RESULTS: The initial stent insertion was successful in 450 (93.8%) patients. TS was achieved in 204 (88.3%) patients treated with PS and in 246 (98.8%) patients palliated with SEMS (p < 0.001). In the intention-to-treat (ITT) analysis, the FS in patients treated with SEMS (97.9%) was significantly higher than in patients treated with PS (84.8%) (p < 0.001). Late complications occurred in 115 (56.4%) patients treated with PS and 60 (24.4%) patients treated with SEMS (p < 0.001). The median duration of stent patency in weeks (w) were as follows: 20 w in patients palliated with PS and 27 w in patients treated with SEMS (p < 0.0001). In Group 2, the median duration of PS patency was 17 w and 18 w for unilateral and bilateral placement, respectively (p = 0.0004); the median duration of SEMS patency was 24 w and 29 w for unilateral and bilateral placement, respectively (p < 0.0001). Multivariate analysis using the Poisson regression showed that SEMS placement (B = 0.48; P < 0.01) and bilateral deployment (B = 0.24; P < 0.01) were the only independent prognostic factors associated with stent patency. CONCLUSIONS: SEMS insertion for the palliation of hilar cholangiocarcinoma offers higher technical and clinical success rates in the ITT analysis as well as lower complication rates and a superior cumulative stent patency when compared with PS placement in all Bismuth classifications. The cumulative patency of bilateral SEMS or PS stents was significantly higher than that of unilateral SEMS or PS stents, with lower occlusion rates in Bismuth II patients.

Sustained relief of obstructive symptoms for the remaining life of patients following placement of an expandable metal stent for malignant colorectal obstruction / Mejoría mantenida durante el resto de la vida de los síntomas obstructivos en pacientes con obstrucciones malignas colorrectales trás la colocación de prótesis metálicas expandibles

Background: self-expanding metal stents are currently being used as a definitive palliative treatment for malignant colorectal obstruction in patients with incurable disease. Few studies have followed large numbers of patients from stent placement until death, and those few have reported conflicting results in the long-term clinical outcome data. Aims: this study evaluated the clinical effectiveness of stent placement for malignant colorectal obstruction throughout the patients’ lives and related factors affecting stent patency, clinical success and complications. Methods: this was a multicentre, retrospective study of 89 consecutive patients who had undergone attempted expandable stent placement for symptomatic malignant colorectal obstruction during a 10-year period. Data were collected to analyse the sustained relief of obstructive symptoms throughout the patients’ lives, as well as the technical success, immediate clinical success, stent patency, complications, reinterventions, survival, prognostic factors associated with stent patency and long-term clinical efficacy and risk factors for complications. Results: technical and immediate clinical success were achieved in 95.5% and 91.0% of patients, respectively. A total of 68 out of 89 patients (76.4%) maintained relief of obstruction from stent implantation until death without reintervention. Twenty patients (22.5%) had complications including perforation (n = 4; 4.5%), stent obstruction (n = 8; 9.0%), migration (n = 5; 5.6%) and haemorrhage (n = 3; 3.4%). Stent-related mortality was seen in 1 patient (1.1%). The estimated median survival and estimated mean stent patency were 87.0 and 322.7 days, respectively. In total, 12 of the initial 89 patients (13.5%) needed a colostomy for long-term relief of the obstructive symptoms. Univariate and multivariate analysis detected no significant prognostic factors associated with stent patency, longterm clinical efficacy and risk factors for complications; however, the multivariate logistic model revealed a non-significant trend by which the use of chemotherapy was a risk factor for migration (OR = 11.89; p = 0.06). Conclusions: for palliation of incurable malignant colorectal obstruction, expandable stents can provide sustained relief of obstruction in approximately 75% of patients. The procedure is associated with acceptable morbidity, need for reintervention and minimal mortality(AU)

A comparison of the temporary placement of 3 different self-expanding stents for the treatment of refractory benign esophageal strictures: a prospective multicentre study.

BACKGROUND: Refractory benign esophageal strictures (RBESs) have been treated with the temporary placement of different self-expanding stents with conflicting results. We compared the clinical effectiveness of 3 types of stents: self-expanding plastic stents (SEPSs), biodegradable stents, and fully covered self-expanding metal stents (FCSEMSs), for the treatment of RBES. METHODS: This study prospectively evaluated 3 groups of 30 consecutive patients with RBESs who underwent temporary placement of either SEPSs (12 weeks, n = 10), biodegradable stents (n = 10) or FCSEMSs (12 weeks, n = 10). Data were collected to analyze the technical success and clinical outcome of the stents as evaluated by recurrent dysphagia, complications and reinterventions. RESULTS: Stent implantation was technically successful in all patients. Migration occurred in 11 patients: 6 (60%) in the SEPS group, 2 (20%) in the biodegradable group and 3 (30%) in the FCSEMS group (P = 0.16). A total of 8/30 patients (26.6%) were dysphagia-free after the end of follow-up: 1 (10%) in the SEPS group, 3 (30%) in the biodegradable group and 4 (40%) in the FCSEMS group (P = 0.27). More reinterventions were required in the SEPS group (n = 24) than in the biodegradable group (n = 13) or the FCSEMS group (n = 13) (P = 0.24). Multivariate analysis showed that stricture length was significantly associated with higher recurrence rates after temporary stent placement (HR = 1.37; 95% CI = 1.08-1.75; P = 0.011). CONCLUSIONS: Temporary placement of a biodegradable stent or of a FCSEMS in patients with RBES may lead to long-term relief of dysphagia in 30 and 40% of patients, respectively. The use of SEPSs seems least preferable, as they are associated with frequent stent migration, more reinterventions and few cases of long-term improvement. Additionally, longer strictures were associated with a higher risk of recurrence.

Oral intake throughout the patients' lives after palliative metallic stent placement for malignant gastroduodenal obstruction: a retrospective multicentre study.

OBJECTIVES: Patients with inoperable malignant gastric outlet obstruction (GOO) have been managed with self-expandable metal stents to improve oral intake. Recent studies have shown conflicting results on the capacity of self-expandable metal stents to restore food intake in the long term. This study evaluated the clinical effectiveness of enteral stent placement for GOO throughout the patients' lives. METHODS: This was a multicentre, retrospective study with a long-term follow-up of 74 patients who underwent enteral stenting for symptomatic GOO. Data were collected to analyse improvements in oral intake for the patients' entire lives as assessed by the GOO scoring system (GOOSS), technical success, stent patency, complications, the need for reintervention, survival and the prognostic factors associated with stent patency. RESULTS: Technical and clinical success was achieved in 100 and 97.2% of the patients, respectively. A total of 71/74 patients (95.9%) continued oral intake for the rest of their lives and 58/74 patients (78.4%) needed no further intervention until death. Solid food intake (GOOSS 2-3) continued until death in 47/74 patients (63.5%). The GOOSS score improved (P<0.001) during the follow-up compared with the baseline. The median survival and the mean stent patency were 8 and 76.6 weeks, respectively. The complication rate was 18.9%. Malignant stent reobstruction was observed in 7/74 patients (9.5%). A Cox multivariate analysis showed that duodenal location of the obstruction was the only independent factor associated with stent patency (hazard ratio=5.28; 95% confidence interval=1.14-24.45; P=0.033). CONCLUSION: Enteral stenting in patients with unresectable GOO is safe and clinically effective. Ninety-five per cent of patients are able to resume oral intake for the rest of their lives, and the great majority remain free from further intervention. In approximately two-thirds of patients, solid food intake continues until death.