Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2012 |
| End Date: | December 2016 |
| Contact: | Michel Kahaleh, MD |
| Email: | mkahaleh@gmail.com |
| Phone: | 646-962-4797 |
Open-label Observational Study of Plastic Cylindrical Fiber Optic Diffuser (Pioneer Optics) in Photodynamic Therapy for the Management of Cholangiocarcinoma.
Successful palliation of biliary obstruction is the main goal for reducing morbidity and
mortality in patients with biliary disease and biliary obstruction related to
cholangiocarcinoma. Surgical intervention for the sale is unfortunately complicated by a
30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time
the quality of life following surgery is only improved in a minority. At present endoscopic
insertion of a plastic or metal stent is the method of choice to relieve obstructive
jaundice without the high morbidity and mortality associated with surgery. But this relief
is unfortunately temporary since stents tend to become obstructed and the fact that
effective biliary drainage in the proximal lesion is challenging.
Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets
neoplastic cells. This therapy involves the intravenous administration of a photosensitizing
agent followed by activation of the agent by illumination with non-thermal light of a
specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis.
A randomized controlled trial study by Ortner et all confirmed the significant advantage of
PDT with regard to relief of jaundice, quality of life, and survival.
In photodynamic therapy (PDT) the uniform distribution of externally applied light is
desirable but often difficult to achieve. An optical fiber tip producing cylindrical or
lateral light emission can facilitate the application of laser energy by direct implantation
of the tip into solid tumors. However, currently used FDA approved glass diffusers used in
standard of care PDT might break in the bile ducts causing injury since they are not meant
to be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need
to evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser
for photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer
plastic optic diffuser is safe and effective in photodynamic therapy, it can be also used
via a choledochoscope. We aim to add to the clinical evidence by conducting an open label
observational study trial using this fiber optic diffuser during photo dynamic therapy in
the bile ducts.
mortality in patients with biliary disease and biliary obstruction related to
cholangiocarcinoma. Surgical intervention for the sale is unfortunately complicated by a
30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time
the quality of life following surgery is only improved in a minority. At present endoscopic
insertion of a plastic or metal stent is the method of choice to relieve obstructive
jaundice without the high morbidity and mortality associated with surgery. But this relief
is unfortunately temporary since stents tend to become obstructed and the fact that
effective biliary drainage in the proximal lesion is challenging.
Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets
neoplastic cells. This therapy involves the intravenous administration of a photosensitizing
agent followed by activation of the agent by illumination with non-thermal light of a
specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis.
A randomized controlled trial study by Ortner et all confirmed the significant advantage of
PDT with regard to relief of jaundice, quality of life, and survival.
In photodynamic therapy (PDT) the uniform distribution of externally applied light is
desirable but often difficult to achieve. An optical fiber tip producing cylindrical or
lateral light emission can facilitate the application of laser energy by direct implantation
of the tip into solid tumors. However, currently used FDA approved glass diffusers used in
standard of care PDT might break in the bile ducts causing injury since they are not meant
to be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need
to evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser
for photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer
plastic optic diffuser is safe and effective in photodynamic therapy, it can be also used
via a choledochoscope. We aim to add to the clinical evidence by conducting an open label
observational study trial using this fiber optic diffuser during photo dynamic therapy in
the bile ducts.
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.
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
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