Comparing quality of life in patients with biliary obstruction treated with different drainage methods
A Comparative Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage of Benign and Malignant Biliary Obstruction
This study is trying to see if patients with bile duct blockages feel better and have a better quality of life after being treated with either a special endoscopic procedure or a different drainage method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04857424 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life in patients suffering from benign and malignant biliary obstruction who are undergoing either endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous trans-hepatic biliary drainage (PTBD). By comparing these two treatment approaches, the study seeks to identify which method may provide better outcomes for patients. Participants will be evaluated based on their experiences and health status following the procedures. The study is conducted at the Mayo Clinic in Rochester, Minnesota.
Who should consider this trial
Good fit: Ideal candidates include patients with either benign or malignant biliary obstruction who are scheduled for ERCP or PTBD.
Not a fit: Patients with gallstone disease or those who have previously undergone the opposite procedure (ERCP or PTBD) will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective drainage method for improving the quality of life in patients with biliary obstruction.
How similar studies have performed: While this study addresses a common clinical issue, similar studies have not been widely reported, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with benign biliary obstruction * Patients with malignant biliary obstruction * Patients undergoing ERCP and/or PTBD Exclusion Criteria: * 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Storm, MD — Mayo Clinic
- Study coordinator: Karl Akiki, MD
- Email: Akiki.karl@mayo.edu
- Phone: (507)284-4723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.