Photodynamic Therapy (PDT) Cholangiocarcinoma Registry

Biliary Stricture Clinical Trial

— PDTRegistry  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524146
• Other study ID #: 1111012021
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2012
• Last updated: February 16, 2017
• Start date: November 2011
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: Michel Kahaleh, M.D.
• Phone: 646-962-4797
• Email: mkahaleh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient who is undergoing PDT for unresectable Cholangiocarcinoma

• Above 18 years of age

Exclusion Criteria:

• Any patient who will not undergo PDT for unresectable Cholangiocarcinoma

• Below 18 years of age

Related Conditions & MeSH terms

• Biliary Obstruction
• Biliary Stricture
• Cholangiocarcinoma
• Cholestasis
• Constriction, Pathologic
• Stent Obstruction
• Unresectable Cholangiocarcinoma

Intervention

Procedure:
• Photodynamic Therapy
PDT is a therapeutic approach that specifically targets neoplastic cells. • PDT involves three components: Photofrin or a similar Photosensitizing agent that would be injected 3 days prior to laser activation of the agent. Laser System - For laser energy delivery to activate the photosensitizing agent and induce tumor tissue necrosis Optic Fiber - Delivery Fiber used along with the laser system to achieve Photoactivation of the photosensitizing agent. Technique: Subjects will be injected with Photofrin or similar drug. 3 days post injection, the subject will receive photodynamic therapy during an Endoscopic Retrograde cholangiopancreatography (ERCP) procedure. Subject will undergo stenting as part of standard of care procedure post photodynamic therapy. Subject may undergo multiple photodynamic therapy sessions with a gap of at least 3 months.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events	3 years
Secondary	Efficacy	Documentation of efficacy: Technical and clinical success rates; and survival duration.; Effectiveness will be assessed by visual inspection of tissue necrosis in the bile ducts one month post photo dynamic therapy delivery.	3 years
Secondary	Concomitant Therapy Effect	Documentation of concomitant/adjuvant therapy and overall survival duration.	3 years