A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct,☆☆,

Presented in abstract form at the Fifth United European Gastroenterology Week in Paris, France, November 1996.
https://doi.org/10.1016/S0016-5107(98)70291-3Get rights and content

Abstract

Background: Although metallic stents remain patent longer than plastic stents, the optimal palliation of inoperable malignant biliary strictures remains controversial because of the high cost of metallic stents and short patient survival. Methods: A total of 101 patients (mean age 72.5 ± 12.9 years) with malignant strictures of the common bile duct were included in this study, after three exclusions for technical failure (n = 3) and one for noncompliance with study design. The etiology of the strictures included pancreatic cancer (65), cholangiocarcinoma (21), ampullary tumor (3), and metastatic lymph nodes (12). Patients were randomized to receive either an 11.5F polyethylene stent to be exchanged in case of dysfunction (group 1, n = 33), an 11.5F stent to be exchanged every 3 months (group 2, n = 34), or a self-expanding metallic Wallstent (group 3, n = 34). Results: Endoscopic procedures were successful (including complete relief of jaundice) in 97.1% of cases. Procedure-related morbidity was 11.9%, and mortality was 2.9%. Bilirubinemia after 48 hours (37.2% ± 21.7% decrease from the preoperative level) did not differ between groups. Patients were followed for a mean of 166 days (median 143, range 0 to 596 days). Overall survivals were not different between groups, but complication-free survival for groups 2 and 3 was longer than that of group 1 (p < 0.05). Cumulated hospital days were 7.4 ± 1.5, 10.6 ± 1.7, and 5.5 ± 1.4 (groups 1, 2, and 3, respectively) (p < 0.05; analysis of variance). Cost analysis showed that metallic stents were advantageous in patients surviving more than 6 months, whereas a plastic stent was advantageous in patients surviving 6 months or less. Conclusions: Metallic stents and plastic stents exchanged every 3 months are valuable alternatives for increasing complication-free survival in patients with malignant strictures of the common bile duct. Metal stents are advantageous in patients with the longest life expectancy. (Gastrointest Endosc 1998;47:1-7.)

Section snippets

Patients and methods

Between March 1993 and March 1995, 105 patients were included in the study. The inclusion criteria were as follows: jaundice secondary to a distal malignant common bile duct stricture with no previous attempts at biliary drainage; patient referral to one of two centers (Bicêtre Hospital or Edouard Herriot Hospital) for endoscopic palliation of jaundice; patient performance status of 0 (asymptomatic), 1 (symptomatic, fully ambulatory), or 2 (symptomatic, in bed less than 50% of day) after

Results

From March 1993 to March 1995, 105 patients were included in the study; four patients were excluded, three for failed endoprosthesis insertion and one in group 2 for not complying with the quarterly stent exchanges. Patient characteristics did not differ between groups (Table 3).

. Patients characteristics

Empty CellGroup 1Group 2Group 3p Value
No. of patients333434
Mean age in years + SEM73.3 + 13.274.5 + 11.071.9 + 13.4NS
(range)(39-92)(52-92)(39-95)
Gender (M/F)17/1617/1715/19NS
Percent weight loss + SEM8 +

Discussion

This study is the first to compare the three main alternatives for endoscopic palliation of malignant jaundice. Our work partially supports the findings of two previous randomized studies comparing metal stents and plastic stents (with exchange for dysfunction).11, 12 Patients treated with a self-expanding metal stent develop fewer symptomatic biliary complications, have a longer symptom-free survival, undergo fewer ERCPs, and spend less time in the hospital than those treated with a plastic

References (22)

  • PB Cotton

    Malignant biliary tract obstruction: endoscopic stenting in context

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    From the Service des Maladies du Fole et de l'Appareil Digestif and INSERM U292, CHU de Bicêtre, Le Kremlin-Bicêtre; and the Département des Spécialités Digestives, Hopital Edouard Herriot, Lyon, France.

    ☆☆

    Reprint requests: F. Prat, MD, PhD, Service des Maladies du Foie et de l'Appareil Digestif, CHU de Bicêtre, 78, rue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex, France.

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