Background and Study Aims: Biliary plastic stents are highly effective in the treatment of malignant biliary obstruction, but may become occluded over time, leading to jaundice and cholangitis. Stent occlusion is thought to be caused by bacterial adhesion and formation of biofilm. This study was carried out to assess whether treatment with ofloxacin in combination with ursodeoxycholic acid is superior to ursodeoxycholic acid alone in preventing stent occlusion.
Patients and Methods: Patients with obstructive jaundice due to inoperable malignant disease underwent placement of a straight 11.5-Fr polyethylene stent. After stent insertion, the patients were randomly assigned to receive either ofloxacin (200 mg b. i. d.) with ursodeoxycholic acid (250 mg t. i. d.) or ursodeoxycholic acid alone. The end points of the study were the frequency of stent occlusions, the time to stent occlusion, and the safety of the two regimens.
Results: Fifty-two patients were enrolled, of whom 26 were assigned to the combined therapy group and 26 to the control group. Thirty patients were suffering from pancreatic cancer, 13 from gallbladder or bile duct cancer, and nine had metastases from other malignant tumors. Eight stent occlusions (31 %) occurred in the ofloxacin group and six (23 %) in the control group (P = 0.76). The mean times to stent occlusion were 95 ± 9 days and 101 ± 9 days, respectively (P = 0.91). No significant differences regarding survival time or safety were observed between the two groups.
Conclusions: Ofloxacin in combination with ursodeoxycholic acid is not superior to ursodeoxycholic acid alone in preventing stent occlusion in patients with malignant obstructive jaundice.
References
-
1
Smith A C, Dowsett J F, Russel R CG, et al.
Randomised trial of endoscopic stenting versus surgical bypass in malignant low bile duct obstruction.
Lancet.
1994;
344
1655-1660
-
2
Davids P HP, Groen A K, Rauws E A, et al.
Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction.
Lancet.
1992;
340
1488-1492
-
3
Speer A G, Cotton P B, MacRae K D.
Endoscopic management of malignant biliary obstruction: stents of 10 French gauge are preferable to stents of 8 French gauge.
Gastrointest Endosc.
1988;
34
412-417
-
4
Sung J JY, Chung S CS.
Endoscopic stenting for palliation of malignant biliary obstruction: a review of progress in the last 15 years.
Dig Dis Sci.
1995;
40
1167-1173
-
5
Van Berkel A M, Boland C, Redekop W K, et al.
A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction.
Endoscopy.
1998;
30
681-686
-
6
Leung J W, Liu Y L, Desta T, et al.
Is there a synergistic effect between mixed bacterial infection in biofilm formation on biliary stents?.
Gastrointest Endosc.
1998;
48
250-257
-
7
Leung J W, Liu Y L, Desta T D, et al.
In vitro evaluation of antibiotic prophylaxis in the prevention of biliary stent blockage.
Gastrointest Endosc.
2000;
51
296-303
-
8
Chin A, Okamoto M P, Gill M A, et al.
Intraoperative concentrations of ofloxacin in serum, bile fluid, and gallbladder wall tissue.
Antimicrob Agents Chemother.
1990;
34
2354-2357
-
9
Barrioz T, Ingrand P, Besson I, et al..
Randomised trial of prevention of biliary stent occlusion by ursodeoxycholic acid plus norfloxacin.
Lancet.
1994;
344
581-582
-
10
Sung J J, Sollano J D, Lai C W, et al.
Long-term ciprofloxacin treatment for the prevention of biliary stent blockage: a prospective randomized study.
Am J Gastroenterol.
1999;
94
3197-3201
-
11
Luman W, Ghosh S, Palmer K R.
A combination of ciprofloxacin and Rowachol does not prevent biliary stent occlusion.
Gastrointest Endosc.
1999;
49
316-321
-
12
De Ledinghen V, Person B, Legoux J L, et al.
Prevention of biliary stent occlusion by ursodeoxycholic acid plus norfloxacin: a multicenter randomized trial.
Dig Dis Sci.
2000;
45
145-150
-
13
Garcia-Marin J J, Dumont M, Corbic M, et al.
Effect of acid-base balance and acetazolamide on ursodeoxycholate-induced biliary bicarbonate secretion.
Am J Physiol.
1985;
248
G20-G27
-
14
Omland E, Mathisen O.
Mechanism of ursodeoxycholic acid- and canrenoate-induced biliary bicarbonate secretion and the effect on glucose- and amino acid-induced cholestasis.
Scand J Gastroenterol.
1991;
26
513-522
-
15
Knyrim K, Wagner H J, Pausch J, Vakil N.
A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct.
Endoscopy.
1993;
25
207-212
-
16
Prat F, Chapat O, Ducot B, et al.
A prospective, randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct.
Gastrointest Endosc.
1998;
47
1-7
-
17
Matsuda Y, Shimakura K, Akamatsu T.
Factors affecting the patency of stents in malignant biliary obstructive disease: univariate and multivariate analysis.
Am J Gastroenterol.
1991;
86
843-849
-
18
Gilbert D A, DiMarino A J, Jensen D M, et al.
Status evaluation: biliary stents.
Gastrointest Endosc.
1992;
38
750-752
-
19
Kazmierczak A, Pechinot A, Duez J M, et al.
Biliary tract excretion of ofloxacin in man.
Drugs.
1987;
34 (Suppl 1)
39-43
-
20
Bergeron M G.
The pharmacokinetics and tissue penetration of the fluoroquinolones.
Clin Invest Med.
1989;
12
20-27
-
21
Ghosh S, Palmer K R.
Prevention of biliary stent occlusion using cyclical antibiotics and ursodeoxycholic acid.
Gut.
1994;
35
1757-1759
U. Halm, M.D.
Dept. of Medicine II
University of Leipzig
Philipp-Rosenthal-Strasse 27
04103 Leipzig
Germany
Fax: Fax:+ 49-341-97-12-209
Email: E-mail:halmu@medizin.uni-leipzig.de
