Suspended Overlength Biliary Stents Preventing Duodenobiliary Reflux in Patients With Biliary Stricture

August 10, 2021 updated by: Huang Yonghui, Peking University Third Hospital

Prevention of Duodenobiliary Reflux Via Suspended Overlength Biliary Stents in Patients With Biliary Stricture

Endoscopic insertion of plastic or metal stents in bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of distal malignant biliary obstruction.Biliary stents are widely used to relieve symptoms of malignant biliary stricture.Now, the mainly used biliary stents include plastic and metal stents. 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 sluge 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 presure in bile duct lowers the duodenals, 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 suspended overlength biliary stents (made from nasobiliary tube with length of 26cm or 30cm) 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 randomized controlled trial to compare the patency of different length of suspended overlength biliary stents and ordinary plastic biliary stents in patients with distal malignant biliary obstruction to evaluate the effect and safety of suspended overlength biliary stents for the prevention of duodenobiliary reflux and the effect of different length of the stents.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endoscopic insertion of plastic or metal stents in bile duct under endoscopic retrograde cholangiopancreatography is a well established treatment of distal malignant biliary obstruction.Biliary stents are widely used to relieve symptoms of malignant biliary stricture.Now, the mainly used biliary stents include plastic and metal stents. 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 sluge 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 presure in bile duct lowers the duodenals, 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 suspended overlength biliary stents (made from nasobiliary tube with length of 26cm or 30cm) 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 randomized controlled trial to compare the patency of different length of suspended overlength biliary stents and ordinary plastic biliary stents in patients with distal malignant biliary obstruction to evaluate the effect and safety of suspended overlength biliary stents for the prevention of duodenobiliary reflux and the effect of different length of the stents.

The investigators will recruit patients according to admission criteria and exclusion criteria. Eligible patients with distal malignant biliary obstruction will be randomly divided into 26cm suspended overlength biliary stents group (experimental group) 、30cm suspended overlength biliary stents group (experimental group) and ordinary plastic biliary stents group (control group).The test groups will be placed the 26cm or 30cm suspended overlength biliary stents in introhepatic 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)

117

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
        • Recruiting
        • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unresectable extrahepatic malignant biliary stricture,available for insertion of biliary stents in ERCP to alleviate biliary stricture.

Exclusion Criteria:

  1. Patients agree with metal biliary stents;
  2. Patients with biliary stricture need double or multiple stents inserted;
  3. Patients with previous surgical drainage procedure;
  4. Patients with resectable biliary occlusion;
  5. A guidewire could not be passed through the stricture;
  6. Patients with duodenal obstruction and duodenal endoscopy could not be reached to papillary.;
  7. Patients with any contraindication to endoscopic procedures or refuse informed consent

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 26cm suspended overlength biliary stents group
Procedure: 26cm suspended overlength biliary stents
The test group will be placed 26cm suspended overlength biliary stents in introhepatic bile duct in ERCP
EXPERIMENTAL: 30cm suspended overlength biliary stents group
Procedure: 30cm suspended overlength biliary stents
The test group will be placed 30cm suspended overlength biliary stents in introhepatic bile duct in ERCP
OTHER: ordinary plastic biliary stents group
Procedure: ordinary plastic biliary stents
The control group will be placed ordinary plastic biliary stents in bile duct in ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 etc.
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 (ACTUAL)

January 11, 2018

Primary Completion (ACTUAL)

March 10, 2021

Study Completion (ANTICIPATED)

September 30, 2021

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

October 11, 2017

First Posted (ACTUAL)

October 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2017187

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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