Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn (A single cohort, alternative trial was started.)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
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University

Tracking Information
First Submitted Date September 20, 2011
First Posted Date September 23, 2011
Last Update Posted Date June 3, 2015
Study Start Date July 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2011)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01439685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy (PDT) During ERCP
Official Title Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Retrospective and Prospective Analysis
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.
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 Type Observational
Study Design Observational Model: Case Control
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects suffering from Cholangiocarcinoma
Condition Cholangiocarcinoma
Intervention Not Provided
Study Groups/Cohorts
  • Biliary Stent plus Photodynamic therapy
    Biliary Stent plus Photodynamic therapy
  • Biliary Stent group
    Biliary Stent group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: June 10, 2014)
0
Original Estimated Enrollment
 (submitted: September 21, 2011)
300
Actual Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01439685
Other Study ID Numbers 1106011779
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michel Kahaleh, Weill Medical College of Cornell University
Study Sponsor Weill Medical College of Cornell University
Collaborators Not Provided
Investigators
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date June 2015