Pancreatic CancerNCT03525353
Comparison Of Radiation Exposure To Patients During Endoscopic Retrograde Cholangiopancreatography (ERCP) Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training
An observational study of Pancreatic Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Purpose: To compare the radiation exposure in patients during Endoscopic retrograde cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of fluoroscopy versus ERCPs done by Endoscopists without such formal training. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2025
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any indications for undergoing an ERCP. If a patient undergoes more than one ERCP then it shall be reported as such, as multiple data points. Only those ERCP cases will be included that have been exposed to fluoroscopy (X-ray radiation). Those in whom the biliary or pancreatic ducts are not cannulated and therefore who do not receive any fluoroscopy will be excluded. Adult populations will be included, all races and belonging to any gender will be included in the study.
Who may be able to join
- Any indications for undergoing an ERCP. If a patient undergoes more than one ERCP then it shall be reported as such, as multiple data points.
- Only those ERCP cases will be included that have been exposed to fluoroscopy (X-ray radiation).
- Adult populations will be included, all races and belonging to any gender will be included in the study.
Who cannot join
- Patients who didn't receive ERCP
- Those in whom the biliary or pancreatic ducts are not cannulated and therefore who do not receive any fluoroscopy
- Pregnant women
- Patient population less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Hermann Hospital
Houston, Texas, 77054
Prithvi Patil, MS, 713-500-6654, prithvi.b.patil@uth.tmc.edu
About this study
Official title: Comparison Of Radiation Exposure To Patients During ERCPs Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training
Purpose: To compare the radiation exposure in patients during Endoscopic retrograde cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of fluoroscopy versus ERCPs done by Endoscopists without such formal training.
Research design: This is an observational study to compare radiation exposure in patients during ERCPs based on formal training.
Read more
Procedures to be used: None Risks and potential benefits There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.
Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to provide new insights and develop newer guidelines for radiation use in the future.
- Conditions
- Pancreatic Cancer
- Being tested
- Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of careOther
No intervention has been used and this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ERCP by formally trained Endoscopists | Patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who are trained on minimum use of fluoroscopy. Receives: Other: Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care | |
| Patients undergoing ERCP by Endoscopists not formally trained | Patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who have not received formal training on minimum use of fluoroscopy. Receives: Other: Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure as assessed by fluoroscopy time
Radiation exposure of patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) will be assessed by fluoroscopy time, which is indicated by the device used for ERCP. Fluoroscopy time at the time of ERCP will be recorded at the end of the procedure and is documented by the endoscopy technician.
Measured: at the time of ERCP
Radiation exposure as assessed by total emittance
Radiation exposure of patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) will be assessed by total emittance, which is indicated by the device used for ERCP. Total emittance at the time of ERCP will be recorded at the end of the procedure and is documented by the endoscopy technician.
Measured: at the time of ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study startNov 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav C Thosani, The University of Texas Health Science Center, Houston
- Investigators
- Nirav Thosani, MD MHA, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525353
- Sponsor's protocol ID
- HSC-MS-15-0019
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2016
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Radiation Exposure To Patients During ERCPs Performed By Endoscopists Trained In Judicious Use Of Fluoroscopy With Those Without Formal Training
- ClinicalTrials.gov ID
- NCT03525353
- Acronym / sponsor ID
- HSC-MS-15-0019
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 May 2018 (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.
Purpose: To compare the radiation exposure in patients during Endoscopic retrograde cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of fluoroscopy versus ERCPs done by Endoscopists without such formal training.
Research design: This is an observational study to compare radiation exposure in patients during ERCPs based on formal training.
Procedures to be used: None Risks and potential benefits There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.
Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to provide new insights and develop newer guidelines for radiation use in the future.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ERCP by formally trained Endoscopists | – | Other: Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of carePatients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who are trained on minimum use of fluoroscopy. |
| Patients undergoing ERCP by Endoscopists not formally trained | – | Other: Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of carePatients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) performed by Endoscopists who have not received formal training on minimum use of fluoroscopy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any indications for undergoing an ERCP. If a patient undergoes more than one ERCP then it shall be reported as such, as multiple data points. Only those ERCP cases will be included that have been exposed to fluoroscopy (X-ray radiation). Those in whom the biliary or pancreatic ducts are not cannulated and therefore who do not receive any fluoroscopy will be excluded. Adult populations will be included, all races and belonging to any gender will be included in the study.
Key inclusion criteria (3 listed)
- Any indications for undergoing an ERCP. If a patient undergoes more than one ERCP then it shall be reported as such, as multiple data points.
- Only those ERCP cases will be included that have been exposed to fluoroscopy (X-ray radiation).
- Adult populations will be included, all races and belonging to any gender will be included in the study.
Key exclusion criteria (4 listed)
- Patients who didn't receive ERCP
- Those in whom the biliary or pancreatic ducts are not cannulated and therefore who do not receive any fluoroscopy
- Pregnant women
- Patient population less than 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 |
|---|---|---|
| Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of careNo intervention has been used and this is an observational study | Other | Patients undergoing ERCP by Endoscopists not formally trained, Patients undergoing ERCP by formally trained Endoscopists |
Primary outcome
Radiation exposure as assessed by fluoroscopy time
Time frame: at the time of ERCP
Radiation exposure of patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) will be assessed by fluoroscopy time, which is indicated by the device used for ERCP. Fluoroscopy time at the time of ERCP will be recorded at the end of the procedure and is documented by the endoscopy technician.
Radiation exposure as assessed by total emittance
Time frame: at the time of ERCP
Radiation exposure of patients who undergo ERCP (Endoscopic Retrograde Cholangio Pancreatography) will be assessed by total emittance, which is indicated by the device used for ERCP. Total emittance at the time of ERCP will be recorded at the end of the procedure and is documented by the endoscopy technician.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
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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.
Nirav Thosani, MD MHA principal investigator
The University of Texas Health Science Center, Houston
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 Pancreatic Cancer, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 4 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 12 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prithvi Patil, MS ((713) 500-6654, prithvi.b.patil@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure as assessed by fluoroscopy time (time frame: at the time of ERCP). 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 12 Jan 2021.