Perihilar CholangiocarcinomaNCT05078801
Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction
An observational study of Perihilar Cholangiocarcinoma and Jaundice, Obstructive, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perihilar Cholangiocarcinoma, Jaundice, Obstructive
- What is being tested?
- Endoscopic drainage and Percutaneous transhepatic biliary drainage
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2021to 30 Oct 2022
- 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: all adults patients hospitalized in Nancy University Hospital with perihilar biliary malignant obstruction who underwent either endoscopic or percutaneous approach for biliary drainage.
Who may be able to join
- hospitalization between january 2006 and march 2022
- perihilar obstruction
- indication of biliary drainage
Who cannot join
- distal biliary obstruction
- perihilar obstruction without indication of biliary drainage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy and Safety of Endoscopic Biliary Drainage and Percutaneous Transhepatic Biliary Drainage for the Management of Perihilar Malignant Biliary Obstruction: a Monocentric Retrospective Study
This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction.
Data from patients admitted in the Nancy University Hospital, France, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.
- Being tested
- Endoscopic drainage, Percutaneous transhepatic biliary drainage
- Keywords
- ERCP, EUS-guided biliary drainage, Percutaneous transhepatic biliary drainage, hilar obstruction
- Medical subject headings
- Klatskin Tumor, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic drainageProcedure or surgery
ERCP and/or EUS-guided biliary drainage
Percutaneous transhepatic biliary drainageProcedure or surgery
US or CT-guided percutaneous drainage
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic drainage | All patients with perihilar malignant biliary obstruction treated with endoscopic drainage. This drainage can be multimodal using endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound (EUS)-guided biliary drainage. Receives: Procedure: Endoscopic drainage | |
| Radiologic percutaneous drainage | All patients with perihilar malignant biliary obstruction treated with percutaneous drainage Receives: Procedure: Percutaneous transhepatic biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin serum level
Diminution of 20% of more on day 7 of the bilirubin serum level
Measured: 7 days
Secondary outcomes (5)
Complications
complication-free survival
Measured: 16 years
number of procedures
total number of procedures, including all endoscopic and radiological interventions
Measured: 16 years
bilirubin serum level on day 30 and on day 90
Measured: 90 days
median survival in months
median survival in month in each group
Measured: 16 years
number of unplanned hospital admissions
total number of unplanned hospital admissions (for unplanned biliary drainage, cholangitis or other complications...)
Measured: 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start15 Jul 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perihilar CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078801
- Sponsor's protocol ID
- 2021PI073
- Status last verified
- Jul 2021
- First submitted
- 5 Aug 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Endoscopic Biliary Drainage and Percutaneous Transhepatic Biliary Drainage for the Management of Perihilar Malignant Biliary Obstruction: a Monocentric Retrospective Study
- ClinicalTrials.gov ID
- NCT05078801
- Acronym / sponsor ID
- 2021PI073
- Keywords
- ERCP, EUS-guided biliary drainage, Percutaneous transhepatic biliary drainage, hilar obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 15 Oct 2021 (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.
This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction.
Data from patients admitted in the Nancy University Hospital, France, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic drainage | – | Procedure: Endoscopic drainageAll patients with perihilar malignant biliary obstruction treated with endoscopic drainage. This drainage can be multimodal using endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound (EUS)-guided biliary drainage. |
| Radiologic percutaneous drainage | – | Procedure: Percutaneous transhepatic biliary drainageAll patients with perihilar malignant biliary obstruction treated with percutaneous drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adults patients hospitalized in Nancy University Hospital with perihilar biliary malignant obstruction who underwent either endoscopic or percutaneous approach for biliary drainage.
Key inclusion criteria (3 listed)
- hospitalization between january 2006 and march 2022
- perihilar obstruction
- indication of biliary drainage
Key exclusion criteria (2 listed)
- distal biliary obstruction
- perihilar obstruction without indication of biliary drainage
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 |
|---|---|---|
| Endoscopic drainageERCP and/or EUS-guided biliary drainage | Procedure or surgery | Endoscopic drainage |
| Percutaneous transhepatic biliary drainageUS or CT-guided percutaneous drainage | Procedure or surgery | Radiologic percutaneous drainage |
Primary outcome
Bilirubin serum level
Time frame: 7 days
Diminution of 20% of more on day 7 of the bilirubin serum level
5 secondary outcomes
Complications
Time frame: 16 years
number of procedures
Time frame: 16 years
bilirubin serum level on day 30 and on day 90
Time frame: 90 days
median survival in months
Time frame: 16 years
number of unplanned hospital admissions
Time frame: 16 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perihilar Cholangiocarcinoma and Jaundice, Obstructive, run by Central Hospital, Nancy, France at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. 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 France. 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?
Results are not available in the source record.
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?
Bilirubin serum level (time frame: 7 days). 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 Oct 2021.