HealthyNCT04340687
Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing PEP
An observational study of Healthy, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Healthy
- What is being tested?
- Pancreatic duct stenting
- Type of treatment
- Medical device
- How many people
- 664 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent ERCP and received administration of rectal indomethacin.
Who may be able to join
- Patients underwent diagnostic or therapeutic ERCP
- With native papilla
- With difficult cannulation (cannulation time >10min or cannulation attempts >5 times or inadvertently PD cannulation ≥1)
- Receiving post-ERCP rectal indomethacin
Who cannot join
- Patients with indications of PD cannulation
- No attempt of cannulation due to inaccessible papilla
- Non-difficult cannulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing Post-ERCP Pancreatitis in Patients With Difficult Cannulation
Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).
- Conditions
- Healthy
- Being tested
- Pancreatic duct stenting
- Keywords
- Indomethacin, Double-guidewire technique, Adverse events, PEP, PD stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic duct stentingDevice
A stent placed in the pancreatic duct to reduce PEP possibly by relieving pancreatic ductal hypertension that develops because of transient procedure-induced edema and stenosis of the pancreatic orifice
| Study group | Role | What they receive |
|---|---|---|
| IP group | All patients recevied pancreatic duct stent during ERCP and one single dose of 100mg rectal indomethacin after ERCP. Receives: Device: Pancreatic duct stenting | |
| IN group | All patients received one single dose of 100mg rectal indomethacin after ERCP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall PEP
PEP was diagnosed if there was a worsening or new onset of pain in the upper abdomen, an elevation in serum amylase of at least three times of the upper limit of the normal range 24h after the procedure and requiring at least two nights of hospitalization.
Measured: 30 days
Secondary outcomes (1)
Overall ERCP related complication
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Jan 2020
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
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 HealthyStudies 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
- 664 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340687
- Sponsor's protocol ID
- 20191115-2
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.
PubMed 25148137Akbar A, Abu Dayyeh BK, Baron TH, Wang Z, Altayar O, Murad MH. Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. Clin Gastroenterol Hepatol. 2013 Jul;11(7):778-83. doi: 10.1016/j.cgh.2012.12.043. Epub 2013 Jan 30.
PubMed 23376320
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing Post-ERCP Pancreatitis in Patients With Difficult Cannulation
- ClinicalTrials.gov ID
- NCT04340687
- Acronym / sponsor ID
- 20191115-2
- Conditions
- Healthy
- Keywords
- Indomethacin, Double-guidewire technique, Adverse events, PEP, PD stenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 9 Apr 2020 (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.
Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IP group | – | Device: Pancreatic duct stentingAll patients recevied pancreatic duct stent during ERCP and one single dose of 100mg rectal indomethacin after ERCP. |
| IN group | – | –All patients received one single dose of 100mg rectal indomethacin after ERCP. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent ERCP and received administration of rectal indomethacin.
Key inclusion criteria (4 listed)
- Patients underwent diagnostic or therapeutic ERCP
- With native papilla
- With difficult cannulation (cannulation time >10min or cannulation attempts >5 times or inadvertently PD cannulation ≥1)
- Receiving post-ERCP rectal indomethacin
Key exclusion criteria (3 listed)
- Patients with indications of PD cannulation
- No attempt of cannulation due to inaccessible papilla
- Non-difficult cannulation
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 |
|---|---|---|
| Pancreatic duct stentingA stent placed in the pancreatic duct to reduce PEP possibly by relieving pancreatic ductal hypertension that develops because of transient procedure-induced edema and stenosis of the pancreatic orifice | Device | IP group |
Primary outcome
Overall PEP
Time frame: 30 days
PEP was diagnosed if there was a worsening or new onset of pain in the upper abdomen, an elevation in serum amylase of at least three times of the upper limit of the normal range 24h after the procedure and requiring at least two nights of hospitalization.
1 secondary outcome
Overall ERCP related complication
Time frame: 30 days
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 9 Apr 2020.
- Background: PubMed 25148137Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.
- Background: PubMed 23376320Akbar A, Abu Dayyeh BK, Baron TH, Wang Z, Altayar O, Murad MH. Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. Clin Gastroenterol Hepatol. 2013 Jul;11(7):778-83. doi: 10.1016/j.cgh.2012.12.043. Epub 2013 Jan 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by Air Force Military Medical University, China at 1 site 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 4 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 9 Apr 2020. 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 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?
Overall PEP (time frame: 30 days). 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 NCT04340687, 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 9 Apr 2020.