Bile Duct CancerNCT04937322
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry.
An observational study of Bile Duct Cancer and Pancreas Cancer, run by Methodist Health System at 1 site in United States.
Trial summary
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 gallbladder and pancreas to the small intestine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Cancer, Pancreas Cancer
- What is being tested?
- Interventional Endoscopy procedures
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2016to 30 Mar 2021
- 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: All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
Who may be able to join
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
- Above 18 years of age.
Who cannot join
- Any patient who has not undergone interventional endoscopy with RFA and stent insertion(s).
- Below 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
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 gallbladder 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 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
Read the detailed description
Background
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 gallbladder 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 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
Objectives:
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 since June 2011 and is ongoing until June 2017:
- To document the immediate and post procedure clinical performance of radio frequency ablation in a "real world" patient population requiring stent implantation for pancreatico-biliary 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 pancreatico-biliary malignancies.
Study Design at Coordinating Center - Weill Cornell Medical College Primary site (WCMC):
This study entails review of data from a database protocol [IRB # 1104011642 : collected for non-research related purposes]. The purpose of this protocol is to establish a database that captures all Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional endoscopy cases. Its objective is to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors, which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients
The registry will review and document:
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2017.
- Data will be reviewed and collected from database protocol IRB # 1104011642.
- No subject intervention is involved in this study. Subject contact is not needed for database review.
Study Design at Secondary sites:
The registry will review and document:
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders.
- No subject intervention is involved in this study. Subject contact is not needed for retrospective review.
- These sites would have IRB approved protocols to collect and send radio frequency ablation procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their prospective protocols and consent/HIPAA forms.
- All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites.
- Relevant IRB documentation will be maintained at both primary and secondary sites.
Registry Hosting:
The coordinating center and primary site (WCMC) will host the registry on the local servers.
A secure Data management or Electronic Data Capture (EDC) system will be used for data entry, compilation and querying.
- Conditions
- Bile Duct Cancer, Pancreas Cancer
- Being tested
- Interventional Endoscopy procedures
- Keywords
- ERCP, endoscopic retrograde cholangiopancreatography, radiofrequency ablation, pancreatico-biliary disorders
- Medical subject headings
- Bile Duct Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional Endoscopy proceduresProcedure or surgery
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Endoscopy procedures | All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2023. Receives: Procedure: Interventional Endoscopy procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Bile Duct Stricture Diameter
Change from Baseline in Bile Duct Stricture Diameter
Measured: June 2011 through June 2021
Adverse Events
Number of Participants with Adverse Events, Type of adverse events, frequency and intensity
Measured: June 2011 through June 2021
Secondary outcomes (2)
survival duration
Documentation of response rates and overall survival duration
Measured: June 2011 through June 2023
stent occlusion-free duration
Documentation of overall stent occlusion-free duration
Measured: June 2011 through June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start25 Jan 2016
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 8 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Prashant Kedia, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937322
- Sponsor's protocol ID
- 003.GID.2016.D
- Status last verified
- Nov 2021
- First submitted
- 21 Sep 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Data will be collected and entered at/submitted to the primary site (WCMC). * A secure Access Database or an alternative secure Electronic Data Capture (EDC) system hosted on the WCMC server will be used for data entry, compilation and reporting.
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. 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
- NCT04937322
- Acronym / sponsor ID
- 003.GID.2016.D
- Conditions
- Bile Duct Cancer, Pancreas Cancer
- Keywords
- ERCP, endoscopic retrograde cholangiopancreatography, radiofrequency ablation, pancreatico-biliary disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- 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.
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 gallbladder 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 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
Detailed description
Background
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 gallbladder 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 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
Objectives:
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 since June 2011 and is ongoing until June 2017:
- To document the immediate and post procedure clinical performance of radio frequency ablation in a "real world" patient population requiring stent implantation for pancreatico-biliary 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 pancreatico-biliary malignancies.
Study Design at Coordinating Center - Weill Cornell Medical College Primary site (WCMC):
This study entails review of data from a database protocol [IRB # 1104011642 : collected for non-research related purposes]. The purpose of this protocol is to establish a database that captures all Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional endoscopy cases. Its objective is to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors, which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients
The registry will review and document:
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2017.
- Data will be reviewed and collected from database protocol IRB # 1104011642.
- No subject intervention is involved in this study. Subject contact is not needed for database review.
Study Design at Secondary sites:
The registry will review and document:
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders.
- No subject intervention is involved in this study. Subject contact is not needed for retrospective review.
- These sites would have IRB approved protocols to collect and send radio frequency ablation procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their prospective protocols and consent/HIPAA forms.
- All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites.
- Relevant IRB documentation will be maintained at both primary and secondary sites.
Registry Hosting:
The coordinating center and primary site (WCMC) will host the registry on the local servers.
A secure Data management or Electronic Data Capture (EDC) system will be used for data entry, compilation and querying.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Endoscopy procedures | – | Procedure: Interventional Endoscopy proceduresAll patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations for pancreatico-biliary disorders since June 2011 and extending forward through June 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
Key inclusion criteria (2 listed)
- All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
- Above 18 years of age.
Key exclusion criteria (2 listed)
- Any patient who has not undergone interventional endoscopy with RFA and stent insertion(s).
- 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 |
|---|---|---|
| Interventional Endoscopy procedures• All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders. | Procedure or surgery | Interventional Endoscopy procedures |
Primary outcome
Measurement of Bile Duct Stricture Diameter
Time frame: June 2011 through June 2021
Change from Baseline in Bile Duct Stricture Diameter
Adverse Events
Time frame: June 2011 through June 2021
Number of Participants with Adverse Events, Type of adverse events, frequency and intensity
2 secondary outcomes
survival duration
Time frame: June 2011 through June 2023
stent occlusion-free duration
Time frame: June 2011 through June 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: Yes. * Data will be collected and entered at/submitted to the primary site (WCMC). * A secure Access Database or an alternative secure Electronic Data Capture (EDC) system hosted on the WCMC server will be used for data entry, compilation and reporting.
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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.
Prashant Kedia, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Cancer and Pancreas Cancer, run by Methodist Health System 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 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: finished, as of the sponsor's last update on 11 Nov 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Bile Duct Stricture Diameter (time frame: June 2011 through June 2021). 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?
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 11 Nov 2021.