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NCT03672019 Clinical Trial

A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

Malignant Biliary Obstruction Clinical Trial

Official title:
Health-Related Quality of Life in Patients Undergoing Percutaneous Biliary Drainage For Malignant Biliary Obstruction

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03672019
Other study ID # 18-366
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 11, 2018
Est. completion date September 2024

Study information
Verified date June 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 118
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with known malignancy presenting for treatment of biliary obstruction - Undergoing initial Interventional Radiology PBD procedure - Fluent in English to enable instrument completion - At least18 years of age - Must be physically and mentally capable of completing instruments - Must be able to comprehend and execute informed consent Exclusion Criteria: - Patients will be excluded if: - Indication for drainage is acute, symptomatic cholangitis requiring an emergent procedure - Previous PBD procedure - Presence of an indwelling biliary stent - Medical or psychiatric condition that, in the judgment of the consenting professional, prevents appropriate comprehension and execution of either the informed consent or the study instruments

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• FACT-Hep
Patient Reported Outcomes (PRO) assessments at baseline and at three time points post-procedure: 4 weeks (+/- 1 weeks), 12 weeks (+/- 2 weeks), and 6 months (+/- 2 weeks).

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (Consent only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent only) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent only) Middletown New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in the FACT-Hep scores The FACT-Hep minimum score is 0 and the maximum is 180. baseline to week 4 post-procedure
See also
  Status Clinical Trial Phase
Recruiting NCT04941924 - The ID- RFA Trial: A Trial of Intraductal Radio-frequency Ablation (ID-RFA) Plus Biliary Stenting Versus Biliary Stenting Alone for the Treatment of Malignant Biliary Obstruction. N/A
Recruiting NCT05220475 - A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent N/A
Completed NCT02001779 - IRS(Irradiation Stent) vs. CS(Conventional Stent) Insertion in Inoperable Malignant Biliary Obstruction N/A
Not yet recruiting NCT06375928 - EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial) N/A
Not yet recruiting NCT06375954 - EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial) N/A
Recruiting NCT05786326 - Multihole Fully Covered Metallic Stents in the Management of Malignant Biliary Obstruction N/A
Not yet recruiting NCT06375967 - EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) N/A
Completed NCT01869894 - A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction N/A
Not yet recruiting NCT05804201 - EUS-guided Hepatico-gastrostomy With Hot Giobor N/A
Recruiting NCT01686425 - Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage N/A
Recruiting NCT03215108 - Comparison Between Novel Flower-type Covered Stent and Conventional Covered Stent N/A
Recruiting NCT04898777 - EUS-Guided Choledochoduodenostomy Versus ERCP for Primary Biliary Decompression in Distal Malignant Biliary Obstruction N/A
Recruiting NCT05169398 - EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent N/A
Enrolling by invitation NCT05233293 - Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma N/A
Completed NCT03812250 - EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction N/A
Completed NCT03000855 - EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures Phase 2/Phase 3
Recruiting NCT01073514 - Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction N/A
Recruiting NCT05142839 - Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction. N/A
Recruiting NCT05729867 - Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC N/A
Completed NCT04405752 - Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study

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