The biliary manometric perfusion test and clinical trial - Long-term predictive value of success after treatment of bile duct strictures: Ten- year experience

PURPOSE: To evaluate the long-term predictive value of the biliary mariometric perfusion test and clinical trial for determining patency after treatment of bile duct strictures. MATERIALS AND METHODS: One hundred four patients with benign biliary disease were treated with surgical (n = 59) or percutaneous (n = 45) techniques followed by intubation with large-caliber silicone stents. Prior to removal of the biliary stents, patients underwent a biliary manometric perfusion test (n = 168) and/or a clinical trial (n = 105) to objectively and subjectively evaluate the treated site for potential long- term patency. The patients were followed up for 1-87 months, and clinical outcomes were determined. Kaplan-Meier survival curves were generated for three patient groups, including those who (i) passed either test, (ii) failed either test, and (iii) failed either test, were re-treated, and passed either test. RESULTS: Final successful treatment outcomes were documented in 47 (92%) surgically and 31 (86%) percutaneously treated patients, respectively (P = .001). The Kaplan-Meier survival curves determined the probability of patency at 0, 2, 4, and 6 years after treatment to he 1.0, .96, .78, and .59, respectively, after passing a biliary manometric perfusion test; and 1.0, .91, .78, and .78, respectively, after passing a clinical trial (P > .10). The probability of patency at 4 years after treatment was .45 after failing a biliary mariometric perfusion test, and at 6 months was zero after failing a clinical trial (P = .001 and .001, respectively, vs the same test in the passing group). Seventy-nine percent of patients who failed either test required an additional period of repeated stent placement or reoperation. After repeated treatment, the probability of patency at 0-4 years was .80 and .88, respectively, for the biliary manometric perfusion test and clinical trial (P > .05 and P > .10, respectively, vs same test in the group that passed). CONCLUSION: Patients who initially pass either the biliary manometric perfusion test or clinical trial have a significantly increased probability of patency versus those who fail; however, patients who fail either test and who then receive definitive additional treatment have a similar probability of patency as those who initially pass. Although the log rank test demonstrated the Kaplan-Meier survival curves from the biliary manometric perfusion test and clinical trial not to be significantly different in any of the three groups (ie, passing, failing, re-treated), the biliary manometric perfusion test is recommended over the clinical trial because of its simplicity, immediate results, and predicted cost savings.