Trial Information

To Establish a Multicenter Registry to Evaluate the Impact of Photodynamic Therapy in the Management of Patients With Unresectable Cholangiocarcinoma.

PDT offers a number of practical advantages; it is minimally invasive and has a low
complication rate, the procedure can easily be performed by a trained endoscopist, and it is
well tolerated. In the trial conducted in Germany, the adverse events of PDT were mild to
moderate, predictable, and relatively easy to control. Photosensitivity was the only
systemic side effect (seen in only three patients). However, provided that simple guidelines
for light exposure are followed, there is minimal risk to the patient, as shown by the low
incidence of photosensitivity reactions in this study which all resolved.

A study from the Mayo group included 25 patients with unresectable cholangiocarcinoma who
were treated with PDT from 1991 to 2004 showed that the time interval between diagnosis and
treatment with PDT is an important predictor of survival following PDT even when adjusted
for other potential factors that affect survival such as age, gender, Bismuth stage,
presence of tumor mass on imaging and presence of extra biliary spread. Early treatment with
PDT may lead to greater preservation of liver function. A recent study by the primary
investigator has also recently reported improved survival in patients receiving PDT and
stent compared to stent only (16.2 months vs 7.4 months).

Several other European studies have reported the efficacy and safety of PDT for
cholangiocarcinoma; however, only a few studies have reported the same in the United States.
This is again due to the fact that PDT is not offered as a therapeutic option for
unresectable cholangiocarcinoma within US.

However, the establishment of a registry to capture all PDT cases within and outside US can
help the investigators evaluate a larger and non ambiguous sample population. This would
help the investigators evaluate the technical success rates, clinical success rates,
feasibility and safety of PDT for unresectable cholangiocarcinoma.

The involvement of international sites is crucial, as the advanced endoscopists all over the
world are offering photodynamic therapy for managing unresectable cholangiocarcinoma.
However, because of the non-existence of a registry, and the fact that PDT is not offered in
more than a few centers in the US; these cases are often reported with a smaller sample
size. The registry hopes to combine all such comparable cases and collect enough relevant
data for statistical analyses.

With more endoscopists considering PDT as a therapeutic option along with adjuvant treatment
for cholangiocarcinoma, there is a need to further evaluate the efficacy and safety of such
combined procedures as well. The ultimate objective is to assess if PDT with or without
additional or adjuvant treatment options prolongs survival duration and improves quality of
life in patients with unresectable cholangiocarcinoma.