NCT01524146

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

7.1 years

First QC Date

January 27, 2012

Last Update Submit

February 16, 2017

Conditions

Unresectable CholangiocarcinomaBiliary ObstructionStent ObstructionBiliary Stricture

Keywords

Unresectable CholangiocarcinomaBiliary obstructionStent obstructionBiliary stricturePhotodynamic therapyPDTAblation

Outcome Measures

Primary Outcomes (1)

  • Safety

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

    3 years

Secondary Outcomes (2)

  • Efficacy

    3 years

  • Concomitant Therapy Effect

    3 years

Study Arms (1)

Photodynamic therapy

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

Procedure: Photodynamic Therapy

Interventions

Photodynamic TherapyPROCEDURE

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.

Also known as: PDT
Photodynamic therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Any patient who is undergoing PDT for unresectable Cholangiocarcinoma
  • Above 18 years of age

You may not qualify if:

  • Any patient who will not undergo PDT for unresectable Cholangiocarcinoma
  • Below 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Weill Medical College of Cornell University

New York, New York, 10021, United States

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Photochemotherapy1-phenyl-3,3-dimethyltriazene

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Michel Kahaleh, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Kahaleh, M.D.

CONTACT

646-962-4797mkahaleh@gmail.com

Monica Gaidhane, MPH

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Advanced Endoscopy

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 1, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2018

Study Completion

December 30, 2018

Last Updated

February 20, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

No IPD Sharing

Locations

US(2)