Outcomes of endoscopic management of primary and refractory postcholecystectomy biliary leaks in a multicentre review of 178 patients.

BACKGROUND: Biliary leaks have been treated with endoscopic management using different techniques with conflicting results. Furthermore the appropriate rescue therapy for refractory leaks has not been established. We evaluated the clinical effectiveness of initial endotherapy for postcholecystectomy biliary leaks using an homogenous approach (sphincterotomy + placement of a 10-French plastic stent) in a large series of patients as well as the optimal and efficacy of rescue endotherapy for refractory biliary leaks. METHODS: This was a multicenter, retrospective study of 178 patients who underwent endoscopic management of postcholecystectomy biliary leaks with a combination of biliary sphincterotomy and the placement of a large-bore (10-French) plastic stent. Data were collected to analyze the clinical outcomes and technical success, efficacy of the rescue endotherapy and the need for surgery, adverse events and prognostic factors for clinical success of endotherapy. RESULTS: Following endotherapy, closure of the leak was accomplished in 162/178 patients (91.0%). The multivariate logistic model showed that the type of leak, namely a high-grade biliary leak, was the only independent prognostic factor associated with treatment failure (OR = 26.78; 95% CI = 6.59-108.83; P < 0.01). The remaining 16 patients were treated with multiple plastic stents (MPSs) with a success rate of 62.5% (10 patients). The use of fewer than 3 plastic stents (P = 0.023) and a high-grade biliary leak (P = 0.034) were shown to be significant predictors of treatment failure with MPSs in refractory bile leaks. The 6 patients in whom the placement of MPSs failed were retreated with a fully cover self-expandable metallic stent (FCSEMS), resulting in closure of the leak in all cases. CONCLUSIONS: Endotherapy of biliary leaks with a combination of biliary sphincterotomy and the placement of a large-bore plastic stent is associated with a high rate of success (90%). However in our series there were several failures using MPSs as a strategy for rescue endotherapy suggesting that refractory biliary leaks should be treated with FCSEMS especially in patients with high-grade leaks.

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.

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.

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.

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.