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Open-label Observational Study of Plastic Cylindrical Fiber Optic Diffuser (Pioneer Optics) in Photodynamic Therapy for the Management of Cholangiocarcinoma.

Phase 2/Phase 3
18 Years
Open (Enrolling)
Cholangiocarcinoma, Biliary Stricture, Biliary Obstruction, Bile Duct Cancer

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Trial Information

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.

Inclusion Criteria:

- Patient with cholangiocarcinoma

- Patient is age 18 years or older

- Patient is receiving Photodynamic therapy with stent(s) placement as part of their
original treatment plan

- Patients must have adequate coagulation as defined below:

Patient's INR ≤ 2 within 30 days of treatment Patient's platelets > 50,000/cmm within 30
days of treatment

Exclusion Criteria:

- Subject has acute porphyria. Subjects exhibiting neurologic or cutaneous symptoms
will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to
determine severity.

- Subject is pregnant.

- Subject is allergic to Photofrin.

- Subject has uncorrected coagulopathy

- Subject is unstable for ERCP

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Efficacy Profile

Outcome Description:

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.

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Michel Kahaleh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

January 2014

Related Keywords:

  • Cholangiocarcinoma
  • Biliary Stricture
  • Biliary Obstruction
  • Bile Duct Cancer
  • Cholangiocarcinoma
  • Biliary Stricture
  • Biliary obstruction
  • Bile Duct Cancer
  • PDT
  • Photodynamic Therapy
  • Plastic optic Diffuser
  • Laser
  • Cholangiocarcinoma
  • Cholestasis
  • Bile Duct Neoplasms
  • Constriction, Pathologic



Weill Cornell Medical CollegeNew York, New York  10021