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Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT01755013
Recruitment Status : Unknown
Verified February 2017 by Michel Kahaleh, Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
First Posted : December 21, 2012
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE March 1, 2012
First Posted Date  ICMJE December 21, 2012
Last Update Posted Date February 20, 2017
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date January 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Efficacy Profile [ Time Frame: 2 months ]
To assess the efficacy of a plastic cylindrical fiber optic diffuser (Pioneer Optics) in photodynamic therapy for the management of Cholangiocarcinoma by visualization of visible necrosis of target tissue in bile ducts after the application of the device.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01755013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
Safety Profile [ Time Frame: 2 months ]
To assess the the number and intensity of adverse events occurring due to the application of the research device.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Safety Profile [ Time Frame: 2 months ]
To assess the the number and intensity of adverse events occurring due to the applicationof the research device.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma
Official Title  ICMJE Open-label Observational Study of Plastic Cylindrical Fiber Optic Diffuser (Pioneer Optics) in Photodynamic Therapy for the Management of Cholangiocarcinoma.
Brief Summary

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 intervention for the sale 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. A randomized controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival.

In photodynamic therapy (PDT) the uniform distribution of externally applied light is desirable but often difficult to achieve. An optical fiber tip producing cylindrical or lateral light emission can facilitate the application of laser energy by direct implantation of the tip into solid tumors. However, currently used FDA approved glass diffusers used in standard of care PDT might break in the bile ducts causing injury since they are not meant to be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need to evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser for photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer plastic optic diffuser is safe and effective in photodynamic therapy, it can be also used via a choledochoscope. We aim to add to the clinical evidence by conducting an open label observational study trial using this fiber optic diffuser during photo dynamic therapy in the bile ducts.

Detailed Description

Cholangiocarcinoma (CCA) is the second most common malignancy arising within the liver, and the association of this malignant condition with high morbidity and mortality is well recognized. It originates from the epithelium of bile ducts or ductules. Two types have been described: the peripheral type occurring in the parenchyma of the liver and the central type occurring within or related to the major bile ducts. Surgery can offer a curative chance, but only a minority of patients are candidates for this therapy at initial presentation since most patients are found with an unresectable tumor.

In unresectable cases, the median survival is 6 months. Since morbidity and mortality from CCA occurs because of biliary obstruction, successful palliation of that complication is the main goal in these patients. Surgical biliary bypass can be offered in order to prolong life and relieve symptoms. This intervention is unfortunately complicated by 30-day postoperative mortality rate between 7 and 24%. Moreover, the quality of life following surgery is only improved in a minority because of the time needed to recover from surgery.

Endoscopic biliary stenting during endoscopic retrograde cholangiopancreatography (ERCP) offers relief from obstructive jaundice without the high morbidity and mortality associated with surgery. In addition, a study by Luman et al even showed significant improvement in emotional, cognitive and global health scores following stenting. But this relief is unfortunately temporary since stents tend to become obstructed.

Local therapies including iridium brachytherapy and photodynamic therapy (PDT) may prevent or postpone these problems.

For more information about PDT, please see the 'Citations' section.

Study Type  ICMJE Interventional
Study Phase Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cholangiocarcinoma
  • Biliary Stricture
  • Biliary Obstruction
  • Bile Duct Cancer
Intervention  ICMJE Procedure: Photodynamic Therapy
Photofrin and Photodynamic therapy using the plastic optic diffuser, conducted during Standard of care Endoscopic retrograde cholangiopancreatography (ERCP)
Other Names:
  • PDT
  • Laser
Study Arms Experimental: PDT Group
Subjects who receive Photodynamic therapy with plastic optic diffuser.
Intervention: Procedure: Photodynamic Therapy
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  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date March 22, 2018
Estimated Primary Completion Date January 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with cholangiocarcinoma
  • Patient is age 18 years or older
  • Patient is receiving Photodynamic therapy with stent(s) placement as part of their original treatment plan
  • Patients must have adequate coagulation as defined below:

Patient's INR ≤ 2 within 30 days of treatment Patient's platelets > 50,000/cmm within 30 days of treatment

Exclusion Criteria:

  • Subject has acute porphyria. Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity.
  • Subject is pregnant.
  • Subject is allergic to Photofrin.
  • Subject has uncorrected coagulopathy
  • Subject is unstable for ERCP
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755013
Other Study ID Numbers  ICMJE 1110011999
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No sharing of IPD
Responsible Party Michel Kahaleh, Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP