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

October 9, 2020 updated by: Huang Yonghui, Peking University Third Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

724

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 papillary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IEBSs in malignant extrahepatic biliary stricture
Intraintestinal extended biliary stents(IEBSs) in patients with malignant extrahepatic biliary stricture
Procedure: intraintestinal extended biliary stents
The test group will be placed intraintestinal extended biliary stents in intrahepatic bile duct in ERCP
Active Comparator: CPBSs in malignant extrahepatic biliary stricture
Conventional plastic biliary stents(CPBSs) in patients with malignant extrahepatic biliary stricture
Procedure: ordinary plastic biliary stents
The test group will be placed ordinary plastic biliary stents in intrahepatic bile duct in ERCP
Experimental: IEBSs in benign extrahepatic biliary stricture
Intraintestinal extended biliary stents(IEBSs) in patients with benign extrahepatic biliary stricture
Procedure: intraintestinal extended biliary stents
The test group will be placed intraintestinal extended biliary stents in intrahepatic bile duct in ERCP
Active Comparator: CPBSs in benign extrahepatic biliary stricture
Conventional plastic biliary stents(CPBSs) in patients with benign extrahepatic biliary stricture
Procedure: ordinary plastic biliary stents
The test group will be placed ordinary plastic biliary stents in intrahepatic bile duct in ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the duration of stent patency and stent occlusion rate
Time Frame: 12 months after ERCP
Patients with symptoms of cholangitis and worsening liver function tests suggestive of cholestasis are considered as premature stent occlusion.
12 months after ERCP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality of each group
Time Frame: 12 months after ERCP
We will compare the mortality of each group after the insertion of biliary stents.
12 months after ERCP
adverse events
Time Frame: 12 months after ERCP
Adverse events include complications of post ERCP such as pancreatitis,biliary infection, bleeding, perforation，and stent migration
12 months after ERCP
the rate of technical success
Time Frame: 12 months after ERCP
Technical success is defined as successful insertion of the stent into the bile duct during ERCP
12 months after ERCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X20200703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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