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Intraintestinal Extended Biliary Stents Preventing Duodenobiliary Reflux in Patients With Biliary Stricture

NCT04550819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 724

Last updated 2020-10-14

No results posted yet for this study

Summary

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.

Conditions

  • Bile Duct Stricture

Interventions

PROCEDURE

intraintestinal extended biliary stents

The test group will be placed intraintestinal extended biliary stents in intrahepatic bile duct in ERCP

PROCEDURE

ordinary plastic biliary stents

The test group will be placed ordinary plastic biliary stents in intrahepatic bile duct in ERCP

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Yonghui Huang, archiater · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2022-10-31
Completion
2023-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04550819 on ClinicalTrials.gov