Bile Duct Stricture Clinical Trial
Official title:
Prevention of Duodenobiliary Reflux Via Intraintestinal Extended Biliary Stents in Patients With Biliary Stricture
Metal or plastic biliary stents placement under Endoscopic Retrograde Cholangiopancreatography(ERCP) is a well-established treatment for patients with benign biliary obstruction to relieve jaundice, a palliative treatment for patients with unresectable malignant pancreaticobiliary obstruction and a bridge to surgery for patients with resectable disease. The main limitation of long time plastic stents is stents occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion, yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents occlusion include biliary sludge of the accumulation of bacteria and duodenal biliary reflux .The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents and the pressure in bile duct lowers the duodenale, which cause the retrograde flow of duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is gradually concerned by clinical researchers. Some studies have showed that plastic stents with antireflux valves can effectively reduce the biliary stent stricture and prolong the stents patency, which means reducing duodenobiliary reflux is surely useful for keeping biliary stent patency.So,we assume to explore an innovatively intraintestinal extended biliary stents (reformed with nasobiliary tube ) as substitution for ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In this study,we will design a multicenter stratified randomized controlled trial to compare the patency of intraintestinal extended biliary stents and ordinary plastic biliary stents in patients with malignant or benign biliary obstruction respectively and evaluate the effect of intraintestinal extended biliary stents for the prevention of duodenobiliary reflux.
Metal or plastic biliary stents placement under ERCP is a well-established treatment for
patients with benign biliary obstruction to relieve jaundice, a palliative treatment for
patients with unresectable malignant pancreaticobiliary obstruction and a bridge to surgery
for patients with resectable disease. Single or multiple plastic stents are recommended for
patients with benign stricture of the common bile duct or malignant stricture if the expected
survival is less than 4 months. The main limitation of long time plastic stents is stents
occlusion. Biliary plastic stents are changed every 2 to 3 months due to an expected median
patency from 77 to 126 days.Metal stents present a lower risk of recurring biliary occlusion,
yet high cost and stents occlusion are eventually inevitable. The mechanism of biliary stents
occlusion include biliary sludge of the accumulation of bacteria and duodenal biliary reflux
.The anti-reflux barrier of Oddi's sphincter disappears after the insertion of biliary stents
and the pressure in bile duct lowers the duodenale, which cause the retrograde flow of
duodenal material into the biliary ducts. Besides, ordinary biliary plastic stent is short
which can also shortens the length of duodenal biliary reflux . Therefore, trying to prevent
the duodenal biliary reflux is very important in reducing biliary stents occlusion and it is
gradually concerned by clinical researchers. Some studies have showed that plastic stents
with antireflux valves can effectively reduce the biliary stent stricture and prolong the
stents patency, which means reducing duodenobiliary reflux is surely useful for keeping
biliary stent patency.So,we assume to explore an innovatively intraintestinal extended
biliary stents with length of 26cm (reformed with nasobiliary tube ) as substitution for
ordinary biliary plastic stent to prevent the duodenobiliary reflux by extending the length
of duodenal content reflux and avoid the stents shift via suspending in intrahepatic duct. In
this study,we will design a multicenter stratified randomized controlled trial to compare the
patency of intraintestinal extended biliary stents and ordinary plastic biliary stents in
patients with malignant or benign biliary obstruction respectively and evaluate the effect of
intraintestinal extended biliary stents for the prevention of duodenobiliary reflux.
This prospective study will be performed at 6 tertiary hospitals in China.The investigators
will recruit patients according to admission criteria and exclusion criteria.The patients
stratified by malignant and benign biliary obstruction will be randomized (at a 1:1 ratio) to
intraintestinal extended biliary stents group (experimental group) and ordinary plastic
biliary stents group (control group).The experimental groups will be placed the
intraintestinal extended biliary stents in intrahepatic bile duct in ERCP. The control group
will be placed ordinary plastic biliary stents in ERCP. The primary endpoint is the duration
of stent patency and the rate of stent occlusion.The secondary outcomes include the mortality
of each group、adverse events and the rate of technical success.
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