Archimedes Bio-degradable Bile Duct Stent Study

NCT04477005 | Completed DMC FDA Device

• 1 other identifier: 20GA041
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Bile Leak; Common Bile Duct Stone With Chronic Cholecystitis

Outcome Measures

Primary Outcomes (2)

• Resolution of bile leak

  In patients who have bile leak post HPB surgery, They will have an external drain to drain the leaked bile. Resolution of bile leak is defined as no output of bile through the external drain.

  180 days

• Incidence of cholangitis in patients who had ERCP for bile duct stones and are awaiting gall bladder removal.

  Cholangitis- infection of bile duct ( fever, rigors, elevated white cell count and CRP). Incidence of cholangitis post procedure will be reported.

  180 days

Interventions

ERCP and insertion ofBio-degradable bile duct stent DEVICE

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.

Also known as: Archimedes BD stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients who need ERCP for bile leak or bile duct stones except participants who are pregnant or breast feeding.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Patients who have an indication for ERCP.
• Patients who have bile leak either post cholecystectomy or liver resection.
• Patients who are on the waiting list for cholecystectomy for gall stones but have bile duct stones and listed for removal of bile duct stones.
• Able (in the Investigators opinion) and willing to comply with all study requirements.
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

• Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
• Patients who are unable to consent for the study.
• Participant who is terminally ill
• Patients who come for ERCP and routine stent change
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Suresh Vasan Venkatachalapathy, MRCP(Gastr)

  NIHR Nottingham BRC,Nottingham University Hospitals NHS Trust and the University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 20, 2020
• Study Start: November 11, 2020
• Primary Completion: September 23, 2022
• Study Completion: August 2, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)