Open-label Observational Study of Plastic Cylindrical Fiber Optic Diffuser (Pioneer Optics) in Photodynamic Therapy for the Management of Cholangiocarcinoma.
Cholangiocarcinoma (CCA) is the second most common malignancy arising within the liver, and
the association of this malignant condition with high morbidity and mortality is well
recognized. It originates from the epithelium of bile ducts or ductules. Two types have been
described: the peripheral type occurring in the parenchyma of the liver and the central type
occurring within or related to the major bile ducts. Surgery can offer a curative chance,
but only a minority of patients are candidates for this therapy at initial presentation
since most patients are found with an unresectable tumor.
In unresectable cases, the median survival is 6 months. Since morbidity and mortality from
CCA occurs because of biliary obstruction, successful palliation of that complication is the
main goal in these patients. Surgical biliary bypass can be offered in order to prolong life
and relieve symptoms. This intervention is unfortunately complicated by 30-day postoperative
mortality rate between 7 and 24%. Moreover, the quality of life following surgery is only
improved in a minority because of the time needed to recover from surgery.
Endoscopic biliary stenting during endoscopic retrograde cholangiopancreatography (ERCP)
offers relief from obstructive jaundice without the high morbidity and mortality associated
with surgery. In addition, a study by Luman et al even showed significant improvement in
emotional, cognitive and global health scores following stenting. But this relief is
unfortunately temporary since stents tend to become obstructed.
Local therapies including iridium brachytherapy and photodynamic therapy (PDT) may prevent
or postpone these problems.
For more information about PDT, please see the 'Citations' section.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
To assess the efficacy of a plastic cylindrical fiber optic diffuser (Pioneer Optics) in photodynamic therapy for the management of Cholangiocarcinoma by visualization of visible necrosis of target tissue in bile ducts after the application of the device.
Michel Kahaleh, MD
Weill Medical College of Cornell University
United States: Food and Drug Administration
|Weill Cornell Medical College||New York, New York 10021|