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.