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

NCT01524146 UNKNOWN

Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma in the United States. Several European studies have reported the efficacy and safety of Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported the same in the United States. 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. 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. This multicenter registry has been initiated: * To document the impact of PDT on the clinical management of unresectable cholangiocarcinoma. * To assess the clinical and technical success rates of PDT for unresectable cholangiocarcinoma.

Details

Lead sponsor	Weill Medical College of Cornell University
Status	UNKNOWN
Enrolment	200
Start date	2011-11
Completion	2018-12-30

Conditions

• Unresectable Cholangiocarcinoma
• Biliary Obstruction
• Stent Obstruction
• Biliary Stricture

Interventions

• Photodynamic Therapy

Primary outcomes

• Safety — 3 years
  Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events

Countries

United States