Endoscopic Retrograde Cholangiopancreatography , GallstoneNCT02697149
Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II
An observational study of Endoscopic Retrograde Cholangiopancreatography , Gallstone, run by Air Force Military Medical University, China at 2 sites in China.
Trial summary
Radiation exposure may put endoscopists at risk when performing endoscopic retrograde cholangiopancreatography. Although non-radiation endoscopic retrograde cholangiopancreatography was reported in pregnant women in previous reports, it remains unclear whether endoscopic retrograde cholangiopancreatography is also… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography , Gallstone
- What is being tested?
- nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography and standard endoscopic retrograde cholangiopancreatography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 219 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2015to Apr 2016
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18-90 years old, patients undergoing endoscopic retrograde cholangiopancreatography
Who may be able to join
- 18-90 years old
- patients undergoing endoscopic retrograde cholangiopancreatography
Who cannot join
- 1 Bismuth typy Ⅲ and Ⅳ
- 2 common bile duct stone > 15mm
- 3 common bile duct stone and distal stenosis
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Department of gastroenterology, Chinese PLA 174 Hospital
Xiamen, Fujian, 361001
About this study
Official title: The Effectiveness and Safety of Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II
Radiation exposure may put endoscopists at risk when performing endoscopic retrograde cholangiopancreatography. Although non-radiation endoscopic retrograde cholangiopancreatography was reported in pregnant women in previous reports, it remains unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe when endoscopists were not expose to radiation. This study was to evaluate the effectiveness and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in patients with complexity level I/II.
- Being tested
- nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography, standard endoscopic retrograde cholangiopancreatography
- Keywords
- ERCP, nonradiation-to-endoscopist, gallstones
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatographyRadiation
All patients received magnetic resonance cholangiopancreatography before the procedure. Characteristics of lesions (e.g. common bile duct stones, stenosis) in detail was identified. During the procedure, the endoscopist was not exposed to radiation. If fluoroscopy was needed, after contrast injection (sometimes not necessary), the endoscopist went outside of the operation room and observed the X-ray image by remote control of the fluoroscopy machine.
standard endoscopic retrograde cholangiopancreatographyRadiation
Patients received standard endoscopic retrograde cholangiopancreatography. Fluoroscopy was normally used when necessary.
| Study group | Role | What they receive |
|---|---|---|
| intervention | patients undergoing nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography Receives: Radiation: nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography | |
| control | patients undergoing standard endoscopic retrograde cholangiopancreatography Receives: Radiation: standard endoscopic retrograde cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of endoscopic retrograde cholangiopancreatography
The success is defined by complete removal of common bile duct stones or placement of stents in proper position.
Measured: 6 months
Secondary outcomes (3)
Overall complications
Post-endoscopic retrograde cholangiopancreatography pancreatitis, bleeding, perforation, infection of biliary tract
Measured: 6 months
Cannulation success rate
In patients with native papilla, cannulation success rate was defined as the proportion of subjects with successful cannulation of targeted duct
Measured: 6 months
ERCP procedure time
defined by the interval time between scope insertion and complete of endoscopic retrograde cholangiopancreatography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Retrograde Cholangiopancreatography , GallstoneStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Yanglin Pan, M.D., Principal investigator, Air Force Military Medical University, ChinaWei Zeng, M.D., Principal investigator, Department of gastroenterology, Chinese PLA 174 hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697149
- Sponsor's protocol ID
- 20151203-5
- Status last verified
- Jul 2016
- First submitted
- 17 Dec 2015
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Uradomo LT, Goldberg EM, Darwin PE. Time-limited fluoroscopy to reduce radiation exposure during ERCP: a prospective randomized trial. Gastrointest Endosc. 2007 Jul;66(1):84-9. doi: 10.1016/j.gie.2006.10.055.
PubMed 17591479Liao C, Thosani N, Kothari S, Friedland S, Chen A, Banerjee S. Radiation exposure to patients during ERCP is significantly higher with low-volume endoscopists. Gastrointest Endosc. 2015 Feb;81(2):391-8.e1. doi: 10.1016/j.gie.2014.08.001. Epub 2014 Oct 5.
PubMed 25293825
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II
- ClinicalTrials.gov ID
- NCT02697149
- Acronym / sponsor ID
- 20151203-5
- Keywords
- ERCP, nonradiation-to-endoscopist, gallstones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Mar 2016 (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.
Radiation exposure may put endoscopists at risk when performing endoscopic retrograde cholangiopancreatography. Although non-radiation endoscopic retrograde cholangiopancreatography was reported in pregnant women in previous reports, it remains unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe when endoscopists were not expose to radiation. This study was to evaluate the effectiveness and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in patients with complexity level I/II.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | – | Radiation: nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatographypatients undergoing nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography |
| control | – | Radiation: standard endoscopic retrograde cholangiopancreatographypatients undergoing standard endoscopic retrograde cholangiopancreatography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18-90 years old, patients undergoing endoscopic retrograde cholangiopancreatography
Key inclusion criteria (2 listed)
- 18-90 years old
- patients undergoing endoscopic retrograde cholangiopancreatography
Key exclusion criteria (3 listed)
- 1 Bismuth typy Ⅲ and Ⅳ
- 2 common bile duct stone > 15mm
- 3 common bile duct stone and distal stenosis
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 |
|---|---|---|
| nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatographyAll patients received magnetic resonance cholangiopancreatography before the procedure. Characteristics of lesions (e.g. common bile duct stones, stenosis) in detail was identified. During the procedure, the endoscopist was not exposed to radiation. If fluoroscopy was needed, after contrast injection (sometimes not necessary), the endoscopist went outside of the operation room and observed the X-ray image by remote control of the fluoroscopy machine. | Radiation | intervention |
| standard endoscopic retrograde cholangiopancreatographyPatients received standard endoscopic retrograde cholangiopancreatography. Fluoroscopy was normally used when necessary. | Radiation | control |
Primary outcome
Success of endoscopic retrograde cholangiopancreatography
Time frame: 6 months
The success is defined by complete removal of common bile duct stones or placement of stents in proper position.
3 secondary outcomes
Overall complications
Time frame: 6 months
Cannulation success rate
Time frame: 6 months
ERCP procedure time
Time frame: 6 months
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 21 Jul 2016.
- Background: PubMed 17591479Uradomo LT, Goldberg EM, Darwin PE. Time-limited fluoroscopy to reduce radiation exposure during ERCP: a prospective randomized trial. Gastrointest Endosc. 2007 Jul;66(1):84-9. doi: 10.1016/j.gie.2006.10.055.
- Results publication: PubMed 25293825Liao C, Thosani N, Kothari S, Friedland S, Chen A, Banerjee S. Radiation exposure to patients during ERCP is significantly higher with low-volume endoscopists. Gastrointest Endosc. 2015 Feb;81(2):391-8.e1. doi: 10.1016/j.gie.2014.08.001. Epub 2014 Oct 5.
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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.
Yanglin Pan, M.D. principal investigator
Air Force Military Medical University, China
Wei Zeng, M.D. principal investigator
Department of gastroenterology, Chinese PLA 174 hospital
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 Endoscopic Retrograde Cholangiopancreatography , Gallstone, run by Air Force Military Medical University, China at 2 sites in China.
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 3 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 21 Jul 2016. 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 China. 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?
Success of endoscopic retrograde cholangiopancreatography (time frame: 6 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 NCT02697149, which also lists 2 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 21 Jul 2016.