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Photodynamic Therapy (PDT) Cholangiocarcinoma Registry

NCT01524146 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2017-02-20

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Photodynamic Therapy

PDT is a therapeutic approach that specifically targets neoplastic cells. • PDT involves three components: 1. Photofrin or a similar Photosensitizing agent that would be injected 3 days prior to laser activation of the agent. 2. Laser System - For laser energy delivery to activate the photosensitizing agent and induce tumor tissue necrosis 3. 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.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Michel Kahaleh, M.D. · Weill Medical College of Cornell University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2018-12-01
Completion
2018-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524146 on ClinicalTrials.gov