Management of malignant hilar biliary obstruction by endoscopy results and prognostic factors

Abstract

Between January 1983 and December 1987, 103 patients who had hilar biliary obstruction (59 men, 44 women, median age 73 years) were referred to our institution. The causes of hilar biliary obstruction were carcinoma of the bile ducts (55), hepatic metastases or hepatocellular carcinoma (30), and carcinoma of the gallbladder (18). When endoscopic retrograde cholangiography was performed, the stricture was classified as type I in 28%, type II in 41%, and type III in 31% of the patients. In 92 patients, we tried to insert endoscopically a 10, 11, or 12 F Amsterdam type prosthesis; it proved possible in 66 (74%), and the prosthesis proved functional without further procedure in 49 cases (53%); no combined percutaneous and endoscopic method was used. At death or discharge, 45 patients (49%) had a successful drainage. Cholangitis was the main procedure-related complication and occurred in 25 patients. The 30-day mortality was 43%. Results varied according to type of stenosis: successful drainage was performed in 15% of the patients with type III stenosis, compared with 86% when the stenosis was of type I. Under a multivariate analysis the independent prognostic factors of 30-day mortality were: (1) development of infectious complications after endoscopic attempt at drainage (P less than 0.0001), and (2) absence of successful drainage (P less than 0.0001). In conclusion, endoscopic endoprosthesis placement allows a sufficient drainage in 53% of the cases. In type III stenosis, the high rate of 30-day mortality leads us the conclusion that endoscopic drainage must be avoided.

Photodynamic therapy for advanced bile duct cancer: Evidence for improved palliation and extended survival

“…28,41 This prospective, single-arm phase II trial rested on 3 assumptions: (1) PDT could achieve a high rate of local tumor response in the biliary tree; (2) progressive tumor occlusion of the liver hilus is the underlying cause of early death 1,[19][20][21] ; (3) less than 50% of historic controls with biliary endoprostheses survived for 6 months after diagnosis. [12][13][14][15] The rationale was to investigate whether PDT can increase the rate of 6-month survival to 70% at least if it keeps the biliary tree patent with acceptable adverse events. *Six patients received a single PDT and 17 patients received 2 PDTs within 8 weeks as initial treatment; the median distance of the biliary tree exposed to the second PDT was 16 cm (range 3-36 cm).…”

“…[12][13][14][15]46,47 Most case series comprised mainly Bismuth type I and II tumors and few type III tumors (21% to 41%) [12][13][14]47 and comprised no or less than 20% type IV tumors. 15,46 Endoprosthesis drainage decreased hyperbilirubinemia by 50% or greater in only 15%, 30%, 41%, and 73%, respectively, of Bismuth type III tumors and none of the type IV tumors, [12][13][14][15]46 and metal stent drainage in 88% of mere type II or III tumors. 48,49 In the present study of cholangiocarcinoma type IV (91%) and III, PDT combined with endoprostheses resulted in bilobar drainage of all patients, and with 1 exception in successful palliation of cholestasis, improved performance and quality of life at the price of a prolonged hospital stay.…”

“…The primary end point was the survival rate at 6 months after diagnosis. Based on the most conservative assumption of a 50% survival rate at 6 months (null-hypothesis) in historic controls with Bismuth type II or III tumor, [12][13][14][15] an increase to 70% or more (alternative hypothesis) could be shown with a power of 80% by investigating a sample size of at least 23 patients (␣ ϭ 0.05, 1-sided test, Fleming' s single step procedure for phase II trials 39,40 ). Survival rates calculated according to Kaplan and Meier were based on intention-to-treat analysis.…”

“…The primary end point was the 6-month survival rate, which is 50% at best in historic controls with biliary drainage. [12][13][14][15] To detect a significant increase to at least 70% survival rate with statistical power of 80%, a cohort of 23 consecutive patients is required (see Statistics section later). Secondary outcome parameters were the rates of local tumor response, adverse events, cholestasis, performance and quality of life, number of procedures, and length of hospital stay.…”

“…2,5 Survival with nonresectable tumor lasts for a median of 3 months without intervention and 4 to 6 months with biliary drainage. [11][12][13][14][15] Given the longer hospitalization time, the adverse effects, and the marginal life extension with anticancer therapies, 2,[16][17][18] usual palliation still is biliary drainage only.…”