A new system for rapid large-caliber percutaneous transhepatic drainage inpatients with obstructive jaundice: A prospective randomized trial

Background and Study Aims: Percutaneous access to the biliary tract is an i mportant diagnostic and therapeutic tool in the management of biliary disea ses. It is usually chosen when the endoscopic approach via endoscopic retro grade cholangiopancreatography (ERCP) fails, or is not possible. Once estab lished, the percutaneous tract is then used for the treatment of biliary st ones and strictures. To establish a percutaneous tract with a caliber large enough for cholangioscopy to be performed, or for a large-bore permanent d rainage tube to be inserted, stepwise dilation up to 14 Fr or 16 Fr is usua lly required. We present here a new method of rapid dilation using speciall y designed materials, including a stiffenable guide wire and specially adap ted bougies. Patients and Methods: Consecutive patients undergoing percutaneous drainage for biliary diseases were included in this prospective study, over a 19-mo nth period. After establishment of a 10-Fr transpapillary drain, the patien ts were randomly assigned to either conventional percutaneous transhepatic biliary drainage (PTBD) or stepwise dilation using the new method, aiming a t a need for only one further session, using a specially designed stiffenab le metal guide wire of 6.6 Fr and plastic bougies. The details of the proce dure (duration, materials used, technical ease), initial and later complica tions, assessment by the patients, and procedural costs were compared betwe en the two groups. Results: Of the 60 patients included, 29 were randomly assigned to group I (the new method) and 31 to group II (the conventional approach); there were no significant differences between the two groups in terms of clinical dat a or biliary pathology. The clinical efficacy of PTBD was similar in the tw o groups, although three patients in group II were switched to the new proc edure because of failure of dilation using the conventional approach. The r ates of major complications (four of 29 in group I, five of 31 in group II) and patient tolerance were also similar. However, the new procedure led to a significant reduction in the cumulative procedure duration (20.1 minutes vs 30.1 minutes), mean number of sessions (1.1 vs. 1.7), and mean number o f hospital days (2.0 vs 5.5), and was therefore also cost-effective, reduci ng costs from a mean of 5813 to 2581 German marks (DM) per patient. Conlusions: The new system for rapid establishment of large-caliber PTBD of fers significant advantages in terms of saving hospital resources while mai ntaining clinical efficacy.