Biliary ObstructionNCT04857424
Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction
An observational study of Biliary Obstruction, run by Mayo Clinic at 1 site in United States.
Trial summary
The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 31 Mar 2026
- 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: Adult patients aged 18 or over with a diagnosis of benign or malignant biliary obstruction who have underwent an ERCP and/or PTBD will be identified through Best Practices Advisory (BPA), referrals from the clinics of GI consultants and the gastroenterology department procedure schedules at Mayo Clinic, Rochester.
Who may be able to join
- Patients with benign biliary obstruction
- Patients with malignant biliary obstruction
- Patients undergoing ERCP and/or PTBD
Who cannot join
- Patients with gallstone disease
- Patients who will undergo ERCP who have previously underwent a PTBD
- Patients who will undergo PTBD who have previously underwent an ERCP
- Female patients who are pregnant
- Prisoners and other vulnerable populations
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Comparative Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage of Benign and Malignant Biliary Obstruction
The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD).
- Conditions
- Biliary Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ERCP | Subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) | |
| PTBD | Subjects with benign and malignant biliary obstruction who have or will undergo percutaneous trans-hepatic biliary drainage (PTBD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in European Quality of Life-5 Dimensions questionnaire score
Measured using the European Quality of Life-5 Dimensions questionnaire that measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro-QOL-5D score is derived from adding the scores from each of the five items. The best possible score is five (i.e., asymptomatic in each item) and the worst possible score is 15 (incapacitated in each item).
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start15 Jul 2021
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jad P. AbiMansour, Mayo Clinic
- Investigators
- Jad AbiMansour, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857424
- Sponsor's protocol ID
- 21-000142
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2021
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage of Benign and Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT04857424
- Acronym / sponsor ID
- 21-000142
- Conditions
- Biliary Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 23 Apr 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.
The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic biliary drainage (PTBD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP | – | –Subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) |
| PTBD | – | –Subjects with benign and malignant biliary obstruction who have or will undergo percutaneous trans-hepatic biliary drainage (PTBD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 or over with a diagnosis of benign or malignant biliary obstruction who have underwent an ERCP and/or PTBD will be identified through Best Practices Advisory (BPA), referrals from the clinics of GI consultants and the gastroenterology department procedure schedules at Mayo Clinic, Rochester.
Key inclusion criteria (3 listed)
- Patients with benign biliary obstruction
- Patients with malignant biliary obstruction
- Patients undergoing ERCP and/or PTBD
Key exclusion criteria (5 listed)
- Patients with gallstone disease
- Patients who will undergo ERCP who have previously underwent a PTBD
- Patients who will undergo PTBD who have previously underwent an ERCP
- Female patients who are pregnant
- Prisoners and other vulnerable populations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in European Quality of Life-5 Dimensions questionnaire score
Time frame: Baseline, 1 month, 3 months
Measured using the European Quality of Life-5 Dimensions questionnaire that measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro-QOL-5D score is derived from adding the scores from each of the five items. The best possible score is five (i.e., asymptomatic in each item) and the worst possible score is 15 (incapacitated in each item).
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 6 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Jad AbiMansour, MD principal investigator
Mayo Clinic
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 Biliary Obstruction, run by Mayo Clinic 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 3 inclusion and 5 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 6 May 2026. 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?
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?
Change in European Quality of Life-5 Dimensions questionnaire score (time frame: Baseline, 1 month, 3 months). 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 6 May 2026.