Photodynamic Therapy (PDT) Cholangiocarcinoma Registry (PDTRegistry)

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

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.

Study Overview

• Status: Unknown
• Conditions: Biliary Stricture; Unresectable Cholangiocarcinoma; Biliary Obstruction; Stent Obstruction
• Intervention / Treatment: Procedure: Photodynamic Therapy

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Monica Gaidhane, MPH; Phone Number: 646-962-4796; Email: mog2012@med.cornell.edu
• Study Contact Backup: Name: Michel Kahaleh, M.D.; Phone Number: 646-962-4797; Email: mkahaleh@gmail.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medical College
      • Principal Investigator: Michel Kahaleg, MD
    • New York, New York, United States, 10021
      • Active, not recruiting
      • Weill Medical College of Cornell University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects suffering from unresectable Cholangiocarcinoma who have a blocked bile duct or biliary stent.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Photodynamic therapy; Subjects who will receive photodynamic therapy for palliation of unresectable Cholangiocarcinoma.

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.; Other Names: PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Concomitant Therapy Effect	Documentation of concomitant/adjuvant therapy and overall survival duration.	3 years

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Michel Kahaleh, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Ablation; Biliary obstruction; Photodynamic therapy; PDT; Biliary stricture; Stent obstruction; Unresectable Cholangiocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Constriction, Pathologic; Cholangiocarcinoma
• Other Study ID Numbers: 1111012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD Sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No