Intraintestinal Extended Biliary Stents Preventing Duodenobiliary Reflux in Patients With Biliary Stricture
Intraintestinal Extended Biliary Stents Preventing Duodenobiliary Reflux 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.
Inclusion Criteria:

 -  Malignant or benign extrahepatic biliary stricture,available for insertion of biliary
 stents in ERCP to alleviate biliary stricture

 Exclusion Criteria:

 -  Patients with malignant or benign biliary stricture do not agree with endoscopic
 treatment

 -  Patients agree with metal biliary stents

 -  Patients with resectable biliary occlusion

 -  A guidewire could not be passed through the stricture

 -  Patients with an expected life survival <3months

 -  Patients with duodenal obstruction and duodenal endoscopy could not be reached to
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