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Clinical Trial
. 2000 Mar;46(3):395-400.
doi: 10.1136/gut.46.3.395.

A prospective randomised multicentre trial comparing 10 Fr Teflon Tannenbaum stents with 10 Fr polyethylene Cotton-Leung stents in patients with malignant common duct strictures

R E England  1 , D F Martin, J Morris, M B Sheridan, R Frost, A Freeman, B Lawrie, M Deakin, I Fraser, K Smith
Affiliations
Clinical Trial

A prospective randomised multicentre trial comparing 10 Fr Teflon Tannenbaum stents with 10 Fr polyethylene Cotton-Leung stents in patients with malignant common duct strictures

R E England et al. Gut. 2000 Mar.

Abstract

Background: Stent blockage is a multifactorial process in which stent design and materials, bacteria, proteins, and bile viscosity play a role.

Aims: To compare the patency of the 10 Fr Teflon Tannenbaum (TT) stent to that of the 10 Fr Cotton-Leung (CL) polyethylene stent with sideholes, in patients with malignant obstructive jaundice.

Methods: Patients were recruited to this prospective multicentre randomised study if they had a newly diagnosed malignant bile duct stricture below the hilum of the liver suitable for stenting with a 10 Fr stent. Data were collected and monitored by a professional monitoring company. Primary patency was the interval between stent placement and first exchange or death without recurrent jaundice.

Results: 134 consecutive patients were recruited between November 1994 and June 1997; 65 were randomised to the TT stent and 69 to the CL stent. Median patency and 95% confidence intervals were 181 (59, 303) days for the TT stent and 133 (92, 174) days for the CL stent, with no significant difference between the two stents (p=0.49). Median survival and 95% confidence intervals were 115 (71, 159) days for the TT stent and 151 (112, 190) days for the CL stent, with no significant difference between the two stents (p=0.765).

Conclusion: Neither Teflon as a stent material nor the Tannenbaum design prolong the patency of plastic stents.

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Figures

Figure 1
Figure 1
Left: the Teflon Tannenbaum stent; right: the polyethylene Cotton-Leung stent.
Figure 2
Figure 2
The Kaplan-Meier plots of patency of the first stent for the two groups. Note that estimates of patency are only accurate up to 297 days for the TT stent and 187 days for the CL stent.
Figure 3
Figure 3
The Kaplan-Meier plots of survival for the two groups. Note that estimates of survival are only accurate up to 504 days for the TT stent and 390 days for the CL stent.
Figure 4
Figure 4
The Kaplan-Meier plots of our data for TT patency compared with those of Seitz et al.1
See this image and copyright information in PMC

Comment in

References

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