CholangiocarcinomaRFA-RegistryNCT01439698
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
An observational study of Cholangiocarcinoma and Pancreatic Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer
- What is being tested?
- Radio Frequency ablation Probe
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to 30 Dec 2018
- How long will I take part?
- 1 Year
- 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 over the age of 18 and suffering from pancreaticobiliary disorders, including malignancies such as Cholangiocarcinoma and Pancreatic Cancer
Who may be able to join
- Patients who have undergone RFA for pancreaticobiliary disorders
- Above 18 years of age
Who cannot join
- Patients who have not undergone RFA
- Below 18 years of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
William R Brugge, MD, 617-724-0578, WBRUGGE@PARTNERS.ORG
William R Brugge, MD
- 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 4797, mog2012@med.cornell.edu
About this study
The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.
Read the detailed description
Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.
The purpose of this registry is to record information and evaluate the impact of radiofrequency ablation (RFA) of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders.
The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated:
- To document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreaticobiliary disorders.
- To assess the immediate and 6 months post procedure adverse event rate in patients.
- To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.
- Conditions
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture, Bile Duct Obstruction
- Being tested
- Radio Frequency ablation Probe
- Keywords
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture, Bile duct obstruction, ENDOHPB, Radio Frequency Ablation, RFA, ERCP, Endoscopic Retrograde Cholangiopancreatography, Registry, Multicenter
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms, Bile Duct Neoplasms, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio Frequency ablation ProbeDevice
Also called ENDOHPB
Any probe that can conduct radiofrequency ablation within biliary ducts.
| Study group | Role | What they receive |
|---|---|---|
| RFA for Pancreatico-biliary disorders | Subjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies. Receives: Device: Radio Frequency ablation Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Bile Duct Stricture Diameter.
Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.
Measured: 4 years
Number of Participants with Adverse Events
Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.
Measured: 4 years
Secondary outcomes (2)
Number of days of survival post intervention
Documentation of response rates,overall survival duration and overall stent occlusion-free duration.
Measured: 4 years
Number of overall stent occlusion-free days post intervention
Documentation of overall stent occlusion-free duration post intervention to highlight quality of life and reduction of interventional procedures.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startSep 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.
- Publications (1)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
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
- NCT01439698
- Sponsor's protocol ID
- 1108011875
- Acronym
- RFA-Registry
- Status last verified
- Feb 2017
- First submitted
- 20 Sep 2011
- 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
Publications
Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.
PubMed 25033929
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
- Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
- ClinicalTrials.gov ID
- NCT01439698
- Acronym / sponsor ID
- RFA-Registry / 1108011875
- Conditions
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture, Bile Duct Obstruction
- Keywords
- Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Cancer, Biliary Stricture, Bile duct obstruction, ENDOHPB, Radio Frequency Ablation, RFA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 23 Sep 2011 (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.
The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.
Detailed description
Bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. Through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. However, due to the cancer, the stents are blocked eventually.
The purpose of this registry is to record information and evaluate the impact of radiofrequency ablation (RFA) of endoscopic radiofrequency ablation (RFA) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. By using radiofrequency (RF) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent implantation(s). The registry will evaluate the efficacy and safety of RFA procedures conducted for pancreatico-biliary disorders.
The safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. This multi-center registry has been initiated:
- To document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreaticobiliary disorders.
- To assess the immediate and 6 months post procedure adverse event rate in patients.
- To assess the impact of RFA on the life expectancy of patients suffering from pancreaticobiliary malignancies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA for Pancreatico-biliary disorders | – | Device: Radio Frequency ablation ProbeSubjects who will receive radiofrequency ablation for pancreatico-biliary disorders, including malignancies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over the age of 18 and suffering from pancreaticobiliary disorders, including malignancies such as Cholangiocarcinoma and Pancreatic Cancer
Key inclusion criteria (2 listed)
- Patients who have undergone RFA for pancreaticobiliary disorders
- Above 18 years of age
Key exclusion criteria (2 listed)
- Patients who have not undergone RFA
- 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 |
|---|---|---|
| Radio Frequency ablation ProbeAlso: ENDOHPBAny probe that can conduct radiofrequency ablation within biliary ducts. | Device | RFA for Pancreatico-biliary disorders |
Primary outcome
Change from Baseline in Bile Duct Stricture Diameter.
Time frame: 4 years
Efficacy Assessment- Change from Baseline in Bile Duct Stricture Diameter.
Number of Participants with Adverse Events
Time frame: 4 years
Safety Assessment - Number of Participants with Adverse Events, type, frequency and intensity.
2 secondary outcomes
Number of days of survival post intervention
Time frame: 4 years
Number of overall stent occlusion-free days post intervention
Time frame: 4 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.
- Results publication: PubMed 25033929Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.
- Individual participant dataSharing planned: No. No IPD Sharing
Related trials for Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
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
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 Cholangiocarcinoma and Pancreatic Cancer, 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, MD (646-962-4000, mik9071@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Bile Duct Stricture Diameter. (time frame: 4 years). The study lists 2 primary outcomes in all. 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 NCT01439698, which also lists 1 linked publication.
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.