NCT01755013

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.

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
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

February 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

6 years

First QC Date

March 1, 2012

Last Update Submit

February 16, 2017

Conditions

CholangiocarcinomaBiliary StrictureBiliary ObstructionBile Duct Cancer

Keywords

CholangiocarcinomaBiliary StrictureBiliary obstructionBile Duct CancerPDTPhotodynamic TherapyPlastic optic DiffuserLaser

Outcome Measures

Primary Outcomes (1)

  • Efficacy Profile

    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.

    2 months

Secondary Outcomes (1)

  • Safety Profile

    2 months

Study Arms (1)

PDT Group

EXPERIMENTAL

Subjects who receive Photodynamic therapy with plastic optic diffuser.

Procedure: Photodynamic Therapy

Interventions

Photodynamic TherapyPROCEDURE

Photofrin and Photodynamic therapy using the plastic optic diffuser, conducted during Standard of care Endoscopic retrograde cholangiopancreatography (ERCP)

Also known as: PDT, Laser
PDT Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Related Publications (3)

  • Talreja JP, DeGaetani M, Sauer BG, Kahaleh M. Photodynamic therapy for unresectable cholangiocarcinoma: contribution of single operator cholangioscopy for targeted treatment. Photochem Photobiol Sci. 2011 Jul;10(7):1233-8. doi: 10.1039/c0pp00259c. Epub 2011 Apr 21.

    PMID: 21512706BACKGROUND

  • Richter JA, Kahaleh M. Photodynamic therapy: Palliation and endoscopic technique in cholangiocarcinoma. World J Gastrointest Endosc. 2010 Nov 16;2(11):357-61. doi: 10.4253/wjge.v2.i11.357.

    PMID: 21173912BACKGROUND

  • Talreja JP, Kahaleh M. Photodynamic therapy for cholangiocarcinoma. Gut Liver. 2010 Sep;4 Suppl 1(Suppl 1):S62-6. doi: 10.5009/gnl.2010.4.S1.S62. Epub 2010 Sep 10.

    PMID: 21103297BACKGROUND

Related Links

MeSH Terms

Conditions

CholangiocarcinomaBile Duct Neoplasms

Interventions

Photochemotherapy1-phenyl-3,3-dimethyltriazeneLasers

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBiliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapyOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Michel Kahaleh, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Kahaleh, MD

CONTACT

646-962-4797mkahaleh@gmail.com

Monica Gaidhane, MD, MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Advanced Endoscopy

Study Record Dates

First Submitted

March 1, 2012

First Posted

December 21, 2012

Study Start

February 1, 2012

Primary Completion

January 22, 2018

Study Completion

March 22, 2018

Last Updated

February 20, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

No sharing of IPD

Locations

US(1)