NCT04170933

Brief Summary

Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 17, 2022

Status Verified

April 1, 2022

Enrollment Period

3.8 years

First QC Date

November 15, 2019

Last Update Submit

May 15, 2022

Conditions

Biliary Anastomotic StrictureBiliary Tract DiseasesCholestasis, ExtrahepaticEndotoxicosis

Keywords

Magnetic recanalizationBiliary Anastomotic StrictureBiliary Tract DiseasesCholestasis, Extrahepatic

Outcome Measures

Primary Outcomes (1)

  • Time duration of biliary recanalization, d (days)

    Time period for recanalization of the bile duct

    From date of treatment (two magnets mated together) until the date of drop-off or the two magnets from the biliary tract or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes (1)

  • Incidence of stricture recurrence

    From date of drop-off of the two magnets until the date of biliary stricture recurrence or end of the follow-up or date of death from any cause, whichever came first, assessed up to 12 months

Study Arms (1)

Magnetic recanalization

EXPERIMENTAL

The subjects in this group will be treated by magnetic recanalization

Procedure: Magnetic recanalization

Interventions

Magnetic recanalizationPROCEDURE

1. Establish a percutaneous transhepatic cholangio drainage (PTCD) fistula. 2. Perform endoscopic sphincterotomy (EST). 3. Place one magnet above the stricture through the PTCD fistula. 4. Introduce another magnet below the stricture through the common bile duct with ERCP. 5. Place the magnets at the appropriate point to attract each other. 6. The patient will be strictly followed, and the magnets will be taken out out of the mouth by the thread connected with the magnets. 7. A plastic stent will be placed in the bile duct for lasting support.

Magnetic recanalization

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ≥ 18 years old and ≤65 years old
  • \. patients with biliary stricture after end-to-end biliary anastomosis

You may not qualify if:

  • \. Pregnant woman
  • Have a history of cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis or electrocardiographic abnormal Q wave (ECG)), stroke (ischemic or hemorrhagic, including transient ischemic attack)
  • \. Severe lung diseases such as COPD and asthma
  • \. Patients with acute infection or inflammation (i.e. pneumonia)
  • \. Any other medical condition considers the longest survival time to be less than 2 years
  • \. Immunodeficiency or HIV positive
  • \. No autonomy, inability to participate in follow-up
  • \. Illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract DiseasesCholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

Digestive System DiseasesCholestasisBile Duct Diseases

Study Officials

  • Yi Lv, MD,phD

    First Affiliated Hospital of Xian JiaotongUniversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Lv, MD,phD

CONTACT

86-29-85323900luyi169@126.com

Xu-Feng Zhang, MD,phD

CONTACT

86-29-85323626xfzhang125@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective study of magnetic recanalization in treatment of biliary stricture
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 20, 2019

Study Start

April 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 17, 2022

Record last verified: 2022-04

Locations

CN(1)