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

This study has been withdrawn prior to enrollment.
(A single cohort, alternative trial was started.)
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University Identifier:
First received: September 20, 2011
Last updated: June 1, 2015
Last verified: June 2015
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.


Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: July 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Biliary Stent plus Photodynamic therapy
Biliary Stent plus Photodynamic therapy
Biliary Stent group
Biliary Stent group

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.


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
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Please refer to this study by its identifier: 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 Identifier: NCT01439685     History of Changes
Other Study ID Numbers: 1106011779
Study First Received: September 20, 2011
Last Updated: June 1, 2015

Keywords provided by 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
Neoplasms processed this record on April 26, 2017