Recruiting

Photodynamic Therapy

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01524146

Conditions

Unresectable Cholangiocarcinoma

Biliary Obstruction

Stent Obstruction

Biliary Stricture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photodynamic Therapy

Study Details

Brief 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

Study ID

NCT01524146

Start date

Nov, 2011

Status verified date

Feb, 2017

Completion date

Dec 30, 2018

Anticipated

Primary completion date

Dec 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Photodynamic therapy

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

Interventions

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.

Primary outcome measure

  • Safety [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Michel Kahaleh, M.D.

646-962-4797mkahaleh@gmail.com

Monica Gaidhane, MPH

646-962-4796mog2012@med.cornell.edu

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Contacts

Michel Kahaleh, MD

646-962-4000mik9071@med.cornell.edu

Monica R Gaidhane, MD, MPH

646-962-4796mog2012@med.cornell.edu

Principal Investigator:

Michel Kahaleg, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 20, 2017

Last verified

Feb, 2017

Keywords

  • Unresectable Cholangiocarcinoma
  • Biliary obstruction
  • Stent obstruction
  • Biliary stricture
  • Photodynamic therapy
  • PDT
  • Ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2017-02-20.