Bile Duct StrictureNCT01414400

Prospective Study to Investigate the Frequency of Possible Bacterial Entry Into the Bloodstream (Bacteremia) and Infectious Complications Associated With the Use of the Spyglass Cholangioscopy System During ERCP (Endoscopic Retrograde Cholangiopancreatography).

A study testing Blood draw for culture in people with Bile Duct Stricture and Choledocholithiasis, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass Direct Visualization System. In addition, the frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Bile Duct Stricture, Choledocholithiasis
What is being tested?: Blood draw for culture
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-80
Biliary disease such as large stones necessitating electrohydraulic lithotripsy;
Biliary strictures needing tissue acquisition through cholangioscopic directed biopsies
Pancreatic-biliary malignancies needing tissue acquisition through cholangioscopic directed biopsies
Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Who cannot join

Age <18, > 80
Potentially vulnerable subjects including pregnant women, homeless people, employees and students.
Patients who have a clear indication for pre-procedure antibiotics based on current ASGE guidelines
Patients who had received antibiotics for any reason within the prior 7 days
Patients who had evidence of systemic infection at time of the ERCP
Patients in whom additional venous access for blood cultures cannot be established.
Participation in another investigational study within the previous 90 days

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Official title: Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope

Read the detailed description

Rates of bacteremia (bacterial seeding of the blood) following ERCP's range from 6.4% to 18.0%. However, infectious complications of cholangitis/sepsis occur in only 0.5%- 3.0% of patients undergoing this procedure. The Spyglass Direct Visualization System allows cholangioscopy with direct visualization of the bile duct during ERCP by using a specialized small caliber endoscope. During the Spyglass portion of the procedure, saline is introduced into the bile duct to to irrigate the biliary system, in order to distend the biliary ducts and to improve visualization by clearing contrast, pus and stone debris. Saline irrigation may increase intrabiliary pressures and may therefore theoretically increase the risk for bacteremia and infection.

The effect of Spyglass cholangioscopy and biliary irrigation on the frequency of bacteremia/post cholangioscopy infections is unknown and has not previously been studied.

The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass system.

Conditions: Bile Duct Stricture, Choledocholithiasis
Being tested: Blood draw for culture
Keywords: Bacteremia, Spyglass, Cholangioscopy
Medical subject headings: Choledocholithiasis, Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood draw for cultureOther
Blood will be drawn and sent for culture.

Study groups in NCT01414400
Study group	Role	What they receive
Choledochoscopy	Other	Patients undergoing ERCP with choledochoscopy Receives: Other: Blood draw for culture

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Bacteremia
This outcome is to assess bacteremia and infection rates in patients following Cholangioscopy with the Spyglass cholangioscope. Positive blood cultures were evaluated for transient ERCP-related bacteremia, and sustained Cholangioscopy-related bacteremia, defined by negative first and second sets of blood cultures but a positive third blood culture obtained 15 minutes after completion of Cholangioscopy and ERCP.
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Dec 2015

First posted11 Aug 2011 (estimated)
Study startAug 2011
Primary completionAug 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bile Duct StrictureStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01414400
Sponsor's protocol ID: SU-07272011-8148
Status last verified: Feb 2025
First submitted: 9 Aug 2011
Last updated: 14 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Thosani N, Zubarik RS, Kochar R, Kothari S, Sardana N, Nguyen T, Banerjee S. Prospective evaluation of bacteremia rates and infectious complications among patients undergoing single-operator choledochoscopy during ERCP. Endoscopy. 2016 May;48(5):424-31. doi: 10.1055/s-0042-101407. Epub 2016 Feb 26.
PubMed 26919263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Primary Sclerosing Cholangitis, Liver Transplant, Complications
Recruiting
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
Biliary Obstruction, Bile Duct Stricture
RecruitingPhase 2
Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis
Acute Cholangitis, Biliary Tract Infection
Active, not recruitingObservational study
Percutaneous Cholangiopancreatoscopy Registry
Biliary Stones, Cholangiocarcinoma, Intrahepatic

All Bile Duct Stricture trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Study of Bacteremia and Infection Rates Following Cholangioscopy With the Spyglass Cholangioscope
ClinicalTrials.gov ID: NCT01414400
Acronym / sponsor ID: SU-07272011-8148
Conditions: Bile Duct Stricture, Choledocholithiasis
Keywords: Bacteremia, Spyglass, Cholangioscopy
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Boston Scientific Corporation
Study start: Aug 2011
Primary completion: Aug 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 11 Aug 2011 (estimated)
Results: Posted 14 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The effect of Spyglass cholangioscopy and biliary irrigation on the frequency of bacteremia/post cholangioscopy infections is unknown and has not previously been studied.

The aim of this study is to prospectively evaluate the frequency of bacteremia after ERCP/cholangioscopy using the Spyglass system.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Choledochoscopy	Other	Other: Blood draw for culturePatients undergoing ERCP with choledochoscopy

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18-80
Biliary disease such as large stones necessitating electrohydraulic lithotripsy;
Biliary strictures needing tissue acquisition through cholangioscopic directed biopsies
Pancreatic-biliary malignancies needing tissue acquisition through cholangioscopic directed biopsies
Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Key exclusion criteria (7 listed)

Age <18, > 80
Potentially vulnerable subjects including pregnant women, homeless people, employees and students.
Patients who have a clear indication for pre-procedure antibiotics based on current ASGE guidelines
Patients who had received antibiotics for any reason within the prior 7 days
Patients who had evidence of systemic infection at time of the ERCP

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood draw for cultureBlood will be drawn and sent for culture.	Other	Choledochoscopy

Primary outcome

Number of Patients With Bacteremia
Time frame: 1 week
This outcome is to assess bacteremia and infection rates in patients following Cholangioscopy with the Spyglass cholangioscope. Positive blood cultures were evaluated for transient ERCP-related bacteremia, and sustained Cholangioscopy-related bacteremia, defined by negative first and second sets of blood cultures but a positive third blood culture obtained 15 minutes after completion of Cholangioscopy and ERCP.

Results and safety

Results posted to the registry on 14 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Choledochoscopy	72	72

Primary outcome: Number of Patients With Bacteremia

Time frame: 1 week. Count of participants. Unit: Participants

Measure	Choledochoscopy n = 72
Had positive blood culture	25
Had true positive blood culture after ERCP/SOC	20
Had false positive blood culture due to contaminants	5
Had bacteremia following cholangioscopy	10
Had bacteremia following ERCP alone	10
Had sustained bacteremia following ERCP/Cholangioscopy	14

Adverse events

Time frame: Up to 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Choledochoscopy	0 of 72 (0%)	20 of 72 (27.8%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26919263Thosani N, Zubarik RS, Kochar R, Kothari S, Sardana N, Nguyen T, Banerjee S. Prospective evaluation of bacteremia rates and infectious complications among patients undergoing single-operator choledochoscopy during ERCP. Endoscopy. 2016 May;48(5):424-31. doi: 10.1055/s-0042-101407. Epub 2016 Feb 26.

Related trials for Bile Duct Stricture

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Primary Sclerosing Cholangitis, Liver Transplant, Complications
Recruiting
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
Biliary Obstruction, Bile Duct Stricture
RecruitingPhase 2
Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis
Acute Cholangitis, Biliary Tract Infection
Active, not recruitingObservational study
Percutaneous Cholangiopancreatoscopy Registry
Biliary Stones, Cholangiocarcinoma, Intrahepatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Subhas Banerjee, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood draw for culture in people with Bile Duct Stricture and Choledocholithiasis, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Bacteremia (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01414400, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.