MedTrace Logo

Archimedes Bio-degradable Bile Duct Stent Study

NCT04477005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2023-08-31

No results posted yet for this study

Summary

This is a prospective observational cohort study to assess the utility of bio-degradable bile duct stent in the drainage of bile duct. All consecutive patients who will undergo ERCP procedure for bile leaks and patients with bile duct stones and intact gall bladder will be recruited to the study. The planned sample size is 53 and patients will be followed up for 180 days. The primary objective is to assess the utility of biodegradable bile duct plastic stents in the drainage of bile duct.

The secondary Secondary objectives are To assess

1. Technical success of biodegradable stents
2. Complications
3. Patient related cost savings (Time off work, travel time for the patient)
4. Hospital related cost savings (Repeat procedure costs, follow up appointments)

Conditions

  • Bile Leak
  • Common Bile Duct Stone With Chronic Cholecystitis

Interventions

DEVICE

ERCP and insertion ofBio-degradable bile duct stent

ERCP is an accepted mode of treatment and patients rarely need surgery for bile leaks and bile duct stents. Endoscopic management involves sphincterotomy (cutting open the Sphincter of Oddi) and insertion of a plastic or metal stent. Instead of placing a plastic stent bio-degradable stent will be placed. They will be followed up on Day 1, 7,30, 60,90 and 180 days. they will have abdominal x-ray on day 90 and day180.

Sponsors & Collaborators

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Suresh Vasan Venkatachalapathy, MRCP(Gastr) · NIHR Nottingham BRC,Nottingham University Hospitals NHS Trust and the University of Nottingham

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2022-09-23
Completion
2023-08-02
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT04477005 on ClinicalTrials.gov