The Biliary Manometric Perfusion Test and Clinical Trial—Long-term Predictive Value of Success after Treatment of Bile Duct Strictures: Ten-year Experience

Abstract

Purpose To evaluate the long-term predictive value of the biliary manometric 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 be 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 manometric 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.