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Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy (PDT) During ERCP (PDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01439685
Recruitment Status : Withdrawn (A single cohort, alternative trial was started.)
First Posted : September 23, 2011
Last Update Posted : June 3, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study entails retrospective and prospective review of data from a database protocol. Data gathered will be then analyzed for a set amount of patients. In this study, the investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy (PDT) and assess if PDT can improve quality of life and prolong survival.

Condition or disease

Detailed Description:

Successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. Surgical biliary bypass is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time the quality of life following surgery is only improved in a minority. At present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. But this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic cells. This therapy involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.

A prospective, randomized and controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival. The improvement of survival in the randomized PDT group was so impressive that it was believed unethical to continue with randomization after the first 39 patients (20 and 19 in each group).Previously, the principal investigator conducted such a study (and also conducted Endoscopic Retrograde Cholangiopancreatography with PDT) at the University of Virginia, and would continue to conduct these procedures, as well as the study at WCMC.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Official Title: Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Retrospective and Prospective Analysis
Study Start Date : July 2011
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Biliary Stent plus Photodynamic therapy
Biliary Stent plus Photodynamic therapy
Biliary Stent group
Biliary Stent group

Outcome Measures

Primary Outcome Measures :
  1. Number of days patients survived post treatment [ Time Frame: 2 years ]
    The group that receives PDT plus stenting will be compared to the group that received stenting only and their survival duration would be evaluated.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects suffering from Cholangiocarcinoma

Inclusion Criteria:

  • Any patient who has undergone ERCP (Endoscopic Retrograde Cholangiopancreatography) and Biliary stenting with or without Photodynamic Therapy.
  • Biliary disorder or obstruction due to Cholangiocarcinoma.
  • Above 18 years of age.

Exclusion Criteria:

  • Any patient who has not undergone ERCP and biliary stenting.
  • Not diagnosed with Cholangiocarcinoma.
  • Below 18 years of age
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439685

United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University
More Information

Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01439685     History of Changes
Other Study ID Numbers: 1106011779
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Michel Kahaleh, Weill Medical College of Cornell University:
Photodynamic Therapy
Bile Duct
Bile Duct Obstruction
Biliary Stent
Obstructive Jaundice

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type