Unresectable CholangiocarcinomaPDTRegistryNCT01524146
Photodynamic Therapy (PDT) Cholangiocarcinoma Registry
An observational study of Unresectable Cholangiocarcinoma and Biliary Obstruction, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma in the United States. Several European studies have reported the efficacy and safety of Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported the same in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Cholangiocarcinoma, Biliary Obstruction, Stent Obstruction
- What is being tested?
- Photodynamic Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to 30 Dec 2018
- Phase
- Observational
- 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
Study population: Subjects suffering from unresectable Cholangiocarcinoma who have a blocked bile duct or biliary stent.
Who may be able to join
- Any patient who is undergoing PDT for unresectable Cholangiocarcinoma
- Above 18 years of age
Who cannot join
- Any patient who will not undergo PDT for unresectable Cholangiocarcinoma
- Below 18 years of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
Weill Cornell Medical College
New York, New York, 10021
Michel Kahaleh, MD, 646-962-4000, mik9071@med.cornell.edu
Monica R Gaidhane, MD, MPH, 646-962-4796, mog2012@med.cornell.edu
- Active, not recruiting
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: To Establish a Multicenter Registry to Evaluate the Impact of Photodynamic Therapy in the Management of Patients With Unresectable Cholangiocarcinoma.
Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma in the United States. Several European studies have reported the efficacy and safety of Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported the same in the United States.
The establishment of a registry to capture all PDT cases within and outside US can help the investigators evaluate a larger and non-ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of PDT for unresectable cholangiocarcinoma. With more endoscopists considering PDT as a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to further evaluate the efficacy and safety of such combined procedures as well. The ultimate objective is to assess if PDT with or without additional or adjuvant treatment options prolongs survival duration and improves quality of life in patients with unresectable cholangiocarcinoma.
Read more
This multicenter registry has been initiated:
- To document the impact of PDT on the clinical management of unresectable cholangiocarcinoma.
- To assess the clinical and technical success rates of PDT for unresectable cholangiocarcinoma.
Read the detailed description
PDT offers a number of practical advantages; it is minimally invasive and has a low complication rate, the procedure can easily be performed by a trained endoscopist, and it is well tolerated. In the trial conducted in Germany, the adverse events of PDT were mild to moderate, predictable, and relatively easy to control. Photosensitivity was the only systemic side effect (seen in only three patients). However, provided that simple guidelines for light exposure are followed, there is minimal risk to the patient, as shown by the low incidence of photosensitivity reactions in this study which all resolved.
A study from the Mayo group included 25 patients with unresectable cholangiocarcinoma who were treated with PDT from 1991 to 2004 showed that the time interval between diagnosis and treatment with PDT is an important predictor of survival following PDT even when adjusted for other potential factors that affect survival such as age, gender, Bismuth stage, presence of tumor mass on imaging and presence of extra biliary spread. Early treatment with PDT may lead to greater preservation of liver function. A recent study by the primary investigator has also recently reported improved survival in patients receiving PDT and stent compared to stent only (16.2 months vs 7.4 months).
Several other European studies have reported the efficacy and safety of PDT for cholangiocarcinoma; however, only a few studies have reported the same in the United States. This is again due to the fact that PDT is not offered as a therapeutic option for unresectable cholangiocarcinoma within US.
However, the establishment of a registry to capture all PDT cases within and outside US can help the investigators evaluate a larger and non ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of PDT for unresectable cholangiocarcinoma.
The involvement of international sites is crucial, as the advanced endoscopists all over the world are offering photodynamic therapy for managing unresectable cholangiocarcinoma. However, because of the non-existence of a registry, and the fact that PDT is not offered in more than a few centers in the US; these cases are often reported with a smaller sample size. The registry hopes to combine all such comparable cases and collect enough relevant data for statistical analyses.
With more endoscopists considering PDT as a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to further evaluate the efficacy and safety of such combined procedures as well. The ultimate objective is to assess if PDT with or without additional or adjuvant treatment options prolongs survival duration and improves quality of life in patients with unresectable cholangiocarcinoma.
- Conditions
- Unresectable Cholangiocarcinoma, Biliary Obstruction, Stent Obstruction, Biliary Stricture
- Being tested
- Photodynamic Therapy
- Keywords
- Unresectable Cholangiocarcinoma, Biliary obstruction, Stent obstruction, Biliary stricture, Photodynamic therapy, PDT, Ablation
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
PDT is a therapeutic approach that specifically targets neoplastic cells.
- PDT involves three components:
- Photofrin or a similar Photosensitizing agent that would be injected 3 days prior to laser activation of the agent.
- Laser System - For laser energy delivery to activate the photosensitizing agent and induce tumor tissue necrosis
- Optic Fiber - Delivery Fiber used along with the laser system to achieve Photoactivation of the photosensitizing agent.
Technique:
Subjects will be injected with Photofrin or similar drug. 3 days post injection, the subject will receive photodynamic therapy during an Endoscopic Retrograde cholangiopancreatography (ERCP) procedure. Subject will undergo stenting as part of standard of care procedure post photodynamic therapy.
Subject may undergo multiple photodynamic therapy sessions with a gap of at least 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy | Subjects who will receive photodynamic therapy for palliation of unresectable Cholangiocarcinoma. Receives: Procedure: Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events
Measured: 3 years
Secondary outcomes (2)
Efficacy
Documentation of efficacy: Technical and clinical success rates; and survival duration.
Effectiveness will be assessed by visual inspection of tissue necrosis in the bile ducts one month post photo dynamic therapy delivery.
Measured: 3 years
Concomitant Therapy Effect
Documentation of concomitant/adjuvant therapy and overall survival duration.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startNov 2011
- Primary completion1 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 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, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524146
- Sponsor's protocol ID
- 1111012021
- Acronym
- PDTRegistry
- Status last verified
- Feb 2017
- First submitted
- 27 Jan 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 IPD Sharing
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
- To Establish a Multicenter Registry to Evaluate the Impact of Photodynamic Therapy in the Management of Patients With Unresectable Cholangiocarcinoma.
- ClinicalTrials.gov ID
- NCT01524146
- Acronym / sponsor ID
- PDTRegistry / 1111012021
- Conditions
- Unresectable Cholangiocarcinoma, Biliary Obstruction, Stent Obstruction, Biliary Stricture
- Keywords
- Unresectable Cholangiocarcinoma, Biliary obstruction, Stent obstruction, Biliary stricture, Photodynamic therapy, PDT, Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 1 Feb 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.
Currently, very few centers offer Photodynamic therapy for unresectable Cholangiocarcinoma in the United States. Several European studies have reported the efficacy and safety of Photodynamic Therapy (PDT) for Cholangiocarcinoma, however, only a few studies have reported the same in the United States.
The establishment of a registry to capture all PDT cases within and outside US can help the investigators evaluate a larger and non-ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of PDT for unresectable cholangiocarcinoma. With more endoscopists considering PDT as a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to further evaluate the efficacy and safety of such combined procedures as well. The ultimate objective is to assess if PDT with or without additional or adjuvant treatment options prolongs survival duration and improves quality of life in patients with unresectable cholangiocarcinoma.
This multicenter registry has been initiated:
- To document the impact of PDT on the clinical management of unresectable cholangiocarcinoma.
- To assess the clinical and technical success rates of PDT for unresectable cholangiocarcinoma.
Detailed description
PDT offers a number of practical advantages; it is minimally invasive and has a low complication rate, the procedure can easily be performed by a trained endoscopist, and it is well tolerated. In the trial conducted in Germany, the adverse events of PDT were mild to moderate, predictable, and relatively easy to control. Photosensitivity was the only systemic side effect (seen in only three patients). However, provided that simple guidelines for light exposure are followed, there is minimal risk to the patient, as shown by the low incidence of photosensitivity reactions in this study which all resolved.
A study from the Mayo group included 25 patients with unresectable cholangiocarcinoma who were treated with PDT from 1991 to 2004 showed that the time interval between diagnosis and treatment with PDT is an important predictor of survival following PDT even when adjusted for other potential factors that affect survival such as age, gender, Bismuth stage, presence of tumor mass on imaging and presence of extra biliary spread. Early treatment with PDT may lead to greater preservation of liver function. A recent study by the primary investigator has also recently reported improved survival in patients receiving PDT and stent compared to stent only (16.2 months vs 7.4 months).
Several other European studies have reported the efficacy and safety of PDT for cholangiocarcinoma; however, only a few studies have reported the same in the United States. This is again due to the fact that PDT is not offered as a therapeutic option for unresectable cholangiocarcinoma within US.
However, the establishment of a registry to capture all PDT cases within and outside US can help the investigators evaluate a larger and non ambiguous sample population. This would help the investigators evaluate the technical success rates, clinical success rates, feasibility and safety of PDT for unresectable cholangiocarcinoma.
The involvement of international sites is crucial, as the advanced endoscopists all over the world are offering photodynamic therapy for managing unresectable cholangiocarcinoma. However, because of the non-existence of a registry, and the fact that PDT is not offered in more than a few centers in the US; these cases are often reported with a smaller sample size. The registry hopes to combine all such comparable cases and collect enough relevant data for statistical analyses.
With more endoscopists considering PDT as a therapeutic option along with adjuvant treatment for cholangiocarcinoma, there is a need to further evaluate the efficacy and safety of such combined procedures as well. The ultimate objective is to assess if PDT with or without additional or adjuvant treatment options prolongs survival duration and improves quality of life in patients with unresectable cholangiocarcinoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy | – | Procedure: Photodynamic TherapySubjects who will receive photodynamic therapy for palliation of unresectable Cholangiocarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from unresectable Cholangiocarcinoma who have a blocked bile duct or biliary stent.
Key inclusion criteria (2 listed)
- Any patient who is undergoing PDT for unresectable Cholangiocarcinoma
- Above 18 years of age
Key exclusion criteria (2 listed)
- Any patient who will not undergo PDT for unresectable Cholangiocarcinoma
- Below 18 years of age
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: PDTPDT is a therapeutic approach that specifically targets neoplastic cells. • PDT involves three components: 1. Photofrin or a similar Photosensitizing agent that would be injected 3 days prior to laser activation of the agent. 2. Laser System - For laser energy delivery to activate the photosensitizing agent and induce tumor tissue necrosis 3. Optic Fiber - Delivery Fiber used along with the laser system to achieve Photoactivation of the photosensitizing agent. Technique: Subjects will be injected with Photofrin or similar drug. 3 days post injection, the subject will receive photodynamic therapy during an Endoscopic Retrograde cholangiopancreatography (ERCP) procedure. Subject will undergo stenting as part of standard of care procedure post photodynamic therapy. Subject may undergo multiple photodynamic therapy sessions with a gap of at least 3 months. | Procedure or surgery | Photodynamic therapy |
Primary outcome
Safety
Time frame: 3 years
Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events
2 secondary outcomes
Efficacy
Time frame: 3 years
Concomitant Therapy Effect
Time frame: 3 years
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.
- Individual participant dataSharing planned: No. No IPD Sharing
Related trials for Unresectable Cholangiocarcinoma
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Biliary Tract Cancer, Cholangiocarcinoma
Not yet recruitingPhase 2
A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
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Recruiting
Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
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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, M.D. principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Cholangiocarcinoma and Biliary Obstruction, run by Weill Medical College of Cornell University at 2 sites 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 2 inclusion and 2 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 2 sites 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.
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, M.D. (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?
Safety (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.