Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma
Status unconfirmed · Phase 2/Phase 3
Conditions studied: Cholangiocarcinoma, Biliary Stricture, Biliary Obstruction, Bile Duct Cancer
In brief
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.
Key facts
- Study ID
- NCT01755013
- Run by
- Weill Medical College of Cornell University
- People needed
- 55
- Starts
- 2012-02-01
- Expected to finish
- 2018-03-22
- Last updated by the study team
- 2017-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Weill Cornell Medical College — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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