Biliary StrictureNCT06039670
Percutaneous Transluminal Forceps Biopsy
An observational study of Biliary Stricture and Biopsy Wound, run by University Hospital, Caen.
Trial summary
To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stricture, Biopsy Wound, Oncology
- What is being tested?
- biliary biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2015to 31 Aug 2016
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with obstructive jaundice referred for percutaneous transhepatic biliary drainage without histological diagnosis
Who may be able to join
- Patients with biliary strictures without histology available
Who cannot join
- Pregnant patients
- Children
About this study
Official title: Percutaneous Transluminal Forceps Biopsy Combined With Transhepatic Biliary Drainage in the Management of Patients With Obstructive Jaundice: Efficacy, Safety and Accuracy
To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture
Read the detailed description
Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy
- Conditions
- Biliary Stricture, Biopsy Wound, Oncology
- Being tested
- biliary biopsy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliary biopsyProcedure or surgery
biliary biopsy through a percutaneous approach during a percutaneous biliary drainage
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PTBD
Efficacy of PTBD : bilirubinemia after PTFB at Day 7
Measured: 7 days
accuracy for percutaneous biliary biopsy (PTFB)
Accuracy of PTFB : percentage of true positive and true negative results by pathologists
Measured: from baseline up to 1 month
incidence of PTFB-related adverse events
Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification
Measured: up to 1 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start2 Jan 2015
- Primary completion31 Jul 2015
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey Fohlen, Principal investigator, Caen UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039670
- Sponsor's protocol ID
- PTFB
- Status last verified
- Jun 2023
- First submitted
- 11 Dec 2017
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Transluminal Forceps Biopsy Combined With Transhepatic Biliary Drainage in the Management of Patients With Obstructive Jaundice: Efficacy, Safety and Accuracy
- ClinicalTrials.gov ID
- NCT06039670
- Acronym / sponsor ID
- PTFB
- Conditions
- Biliary Stricture, Biopsy Wound, Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture
Detailed description
Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with obstructive jaundice referred for percutaneous transhepatic biliary drainage without histological diagnosis
Key inclusion criteria (1 listed)
- Patients with biliary strictures without histology available
Key exclusion criteria (2 listed)
- Pregnant patients
- Children
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 |
|---|---|---|
| biliary biopsybiliary biopsy through a percutaneous approach during a percutaneous biliary drainage | Procedure or surgery | – |
Primary outcome
Efficacy of PTBD
Time frame: 7 days
Efficacy of PTBD : bilirubinemia after PTFB at Day 7
accuracy for percutaneous biliary biopsy (PTFB)
Time frame: from baseline up to 1 month
Accuracy of PTFB : percentage of true positive and true negative results by pathologists
incidence of PTFB-related adverse events
Time frame: up to 1 month after procedure
Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Audrey Fohlen principal investigator
Caen UH
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Stricture and Biopsy Wound, run by University Hospital, Caen.
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 1 inclusion and 2 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of PTBD (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2023.