A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis

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• 作者：Quan Wai Leong ; MBBS ; MRCP¹ ; ; Mira L. Shen¹ ; Kim W. Au ; MSc² ; Derek Luo ; MBChB ; FRACP² ; James Y. Lau ; MD ; FRCS² ; Justin C. Wu ; MD ; FRCP² ; Francis K. Chan ; MD ; FRCP² ; Joseph J. Sung ; PhD²
• 关键词：ARBS ; antireflux biliary stent ; OTS ; ordinary Tannenbaum stent
• 刊名：Gastrointestinal Endoscopy
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：83
• 期：2
• 页码：387-393
• 全文大小：884 K

文摘

There is as yet no ideal design of a plastic biliary stent with the longest patency period.

Objective

To study the safety and effective patency period of a new plastic antireflux biliary stent in the clinical setting.

Design

We conducted a prospective, randomized trial to compare the patency of 2 similar plastic biliary stents, one of which has an antiduodenobiliary reflux property.

Setting

The study was conducted at 2 separate tertiary centers in 2 countries.

Patients

Patients with inoperable distal malignant biliary obstruction were recruited.

Interventions

One of the 2 types of plastic stents under study was randomly chosen and inserted in the common bile duct of the study subjects. The subjects were followed until the end of study or occlusion occurrence.

Main Outcome Measurements

Our primary endpoint was the time to stent occlusion in days, with stent-related adverse events and all-cause mortality the secondary endpoints.

Results

A total of 16 subjects were recruited for the study; 7 were allocated to group A (ordinary Tannenbaum stent) and 9 to group B (antireflux biliary stent). Five of 7 subjects (71%) in group B had stent occlusion within 8 days, and the primary end point was reached in all 7 subjects within 30 days, whereas the primary endpoint was not reached within 30 days in any of the subjects in group A. Our data showed a significantly shorter stent patency period in group B compared with group A (P < .003).

Limitations

Small sample size.

Conclusion

Routine use of antireflux plastic biliary stents in the palliative management of malignant biliary obstructions cannot be recommended at present. (Clinical trial registration number: NCT01142921.)