CholangiocarcinomaPhase 2/3NCT01755013
Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma
A Phase 2/3 study testing Photodynamic Therapy in people with Cholangiocarcinoma and Biliary Stricture, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Biliary Stricture, Biliary Obstruction
- What is being tested?
- Photodynamic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 22 Mar 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College
New York, New York, 10021
Michel Kahaleh, MD, 646-962-4797, mkahaleh@gmail.com
Monica Gaidhane, MD, MPH, 646-962-4796, mog2012@med.cornell.edu
About this study
Official title: Open-label Observational Study of Plastic Cylindrical Fiber Optic Diffuser (Pioneer Optics) in Photodynamic Therapy for the Management of Cholangiocarcinoma.
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.
Read the 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.
- Being tested
- Photodynamic Therapy
- Keywords
- Cholangiocarcinoma, Biliary Stricture, Biliary obstruction, Bile Duct Cancer, PDT, Photodynamic Therapy, Plastic optic Diffuser, Laser
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic TherapyProcedure or surgery
Also called PDT, Laser
Photofrin and Photodynamic therapy using the plastic optic diffuser, conducted during Standard of care Endoscopic retrograde cholangiopancreatography (ERCP)
| Study group | Role | What they receive |
|---|---|---|
| PDT Group | Experimental | Subjects who receive Photodynamic therapy with plastic optic diffuser. Receives: Procedure: Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
Safety Profile
To assess the the number and intensity of adverse events occurring due to the application of the research device.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startFeb 2012
- Primary completion22 Jan 2018 (estimated)
- Study completion22 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Kahaleh, Weill Medical College of Cornell University
- Investigators
- Michel Kahaleh, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755013
- Sponsor's protocol ID
- 1110011999
- Status last verified
- Feb 2017
- First submitted
- 1 Mar 2012
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of IPD
Publications
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.
PubMed 21512706Richter 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.
PubMed 21173912Talreja 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.
PubMed 21103297
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Observational Study of Plastic Cylindrical Fiber Optic Diffuser (Pioneer Optics) in Photodynamic Therapy for the Management of Cholangiocarcinoma.
- ClinicalTrials.gov ID
- NCT01755013
- Acronym / sponsor ID
- 1110011999
- Keywords
- Cholangiocarcinoma, Biliary Stricture, Biliary obstruction, Bile Duct Cancer, PDT, Photodynamic Therapy, Plastic optic Diffuser, Laser
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 22 Jan 2018 (estimated)
- Study completion
- 22 Mar 2018 (estimated)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDT Group | Experimental | Procedure: Photodynamic TherapySubjects who receive Photodynamic therapy with plastic optic diffuser. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic TherapyAlso: PDT, LaserPhotofrin and Photodynamic therapy using the plastic optic diffuser, conducted during Standard of care Endoscopic retrograde cholangiopancreatography (ERCP) | Procedure or surgery | PDT Group |
Primary outcome
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.
1 secondary outcome
Safety Profile
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Background: PubMed 21512706Talreja 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.
- Background: PubMed 21173912Richter 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.
- Background: PubMed 21103297Talreja 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.
- Photodynamic therapy for unresectable cholangiocarcinoma: contribution of single operator cholangioscopy for targeted treatment. Talreja JP, DeGaetani M, Sauer BG, Kahaleh M.Link provided by the sponsor.
- Photodynamic therapy: Palliation and endoscopic technique in cholangiocarcinoma. Richter JA, Kahaleh M.Link provided by the sponsor.
- Photodynamic therapy for cholangiocarcinoma. Talreja JP, Kahaleh M.Link provided by the sponsor.
- Individual participant dataSharing planned: No. No sharing of IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Kahaleh, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Photodynamic Therapy in people with Cholangiocarcinoma and Biliary Stricture, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Kahaleh, MD (646-962-4797, mkahaleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Profile (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01755013, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.