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Prospective randomized trial comparing Tannenbaum Teflon and standard polyethylene stents in distal malignant biliary stenosis.

Abstract：

BACKGROUND:Our aim was to compare the clinical efficacy of the Tannenbaum (TB) biliary prostheses, a recently designed Teflon stent without side holes, with the Cotton-Huibregtse (CH) polyethylene stent. METHODS:Fifty-seven patients (26 men, mean age 75.5 years) with unresectable malignant tumors and distal biliary stenosis were included (38 pancreatic head cancer, 17 cholangiocarcinoma, 2 ampullary cancer). Patients were prospectively randomized to have a 10F, 7 cm long TB (29 patients) or CH (28 patients) stent inserted endoscopically. Four patients (2 TB and 2 CH) were excluded: 3 because of the failure of stent insertion and 1 because of a protocol violation. The patients were evaluated clinically and, if necessary, with biochemical tests every month until death or until they needed surgery for symptoms of gastric outlet obstruction. When occlusion or dislocation occurred, the stent was replaced with one of the same type. Cumulative stent patency and patient survival were estimated with the Kaplan-Meier life-table analysis and compared by log-rank chi-square test. RESULTS:The two groups were comparable in mean age, gender, and diagnosis. The patients were followed for a mean of 145.5 days (range 24 to 613); by the end of the study 47 patients (81%) had died or developed symptoms of gastric outlet obstruction. Median survival was 88 days (range 24 to 613) in the TB group and 75.6 days (23 to 486) in the CH group. Stent exchange (occlusion 16, dislocation 3) was necessary for 5 patients in the TB group and 7 in the CH group. No statistical difference was found on comparing the mean duration of function of the first, second, and third stents (analysis of variance, p = 0.80). The median duration of stent function was 96 days (range 11 to 613) in the TB group and 75.5 days (range 23 to 323) in the CH group. No significant difference was found in either survival time (p = 0.48) or stent patency (p = 0.12). CONCLUSION:This study found no significant advantage of the Tannenbaum prostheses over the standard polyethylene stent in the palliation for patients with distal malignant biliary stenosis with regard to survival or length of stent patency.

journal_name

Gastrointest Endosc

journal_title

Gastrointestinal endoscopy

authors

Terruzzi V,Comin U,De Grazia F,Toti GL,Zambelli A,Beretta S,Minoli G

doi

10.1016/s0016-5107(00)70381-6

keywords:

subject

Has Abstract

pub_date

2000-01-01 00:00:00

pages

23-7

issue

eissn

0016-5107

issn

1097-6779

pii

S0016-5107(00)70381-6

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Prospective randomized trial comparing Tannenbaum Teflon and standard polyethylene stents in distal malignant biliary stenosis.