Post-ERCP Acute PancreatitisNCT04145336
7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients
A study testing 5cm 5-Fr PDS, 7cm 5-Fr PDS and Indomethacin in people with Post-ERCP Acute Pancreatitis, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) is estimated to be 10% to 15% in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- 5cm 5-Fr PDS, 7cm 5-Fr PDS and Indomethacin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2019to 31 Oct 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Un-intentional pancreatic duct cannulation:
- 2 or more times;
- 1 time with more than 10 minutes cannulation.
- Double-wire technique;
- High-risk patients:
- met at least 1 of the major criteria
Show all 17Show fewer
- Clinical suspicion of sphincter of Oddi dysfunction;
- Pancreatic sphincterotomy
- Delayed precut sphincterotomy
- ≥ 8 cannulation attempts
- Pneumatic dilatation of an intact biliary sphincter
- Ampullectomy
- or met at least 2 or more of the minor criteria
- Age < 50;
- Female;
- Normal TBIL;
- ≥ 3 injections of contrast into the pancreatic duct with ≥ 1 injection to the tail of the pancreas;
Who cannot join
- Therapeutic PDS;
- Acute pancreatitis within 3 days;
- With a history of pancreatic surgery or biliary-enteric anastomosis;
- Pregnant or breastfeeding women;
- unwilling or inability to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients: a Multicentre, Single-blinded, Randomised Controlled Trial
Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) is estimated to be 10% to 15% in high-risk patients. Current guidelines recommend using pancreatic duct stent (PDS) for PEP prevention in high-risk patients, but it is not clear whether stent length will affect the effect of PEP prevention. The longer PDS will remain in the pancreatic duct for a longer period of time, thereby ensuring prolonged decompression with subsequent lowering of the risk for PEP. Findings from two retrospective studies showed that longer PDS was more effective in reducing the risk of post-ERCP hyperamylasemia and the frequency of PEP compared with the shorter PDS. We conducted this trial to test whether 7cm PDS was superior to 5cm PDS in PEP prevention in high-risk patients.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- 5cm 5-Fr PDS, 7cm 5-Fr PDS, Indomethacin
- Keywords
- ERCP, PEP, Post-ERCP pancreatitis, Pancreatic duct stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5cm 5-Fr PDSDevice
High-risk patients receive 5cm 5-Fr PDS
7cm 5-Fr PDSDevice
High-risk patients receive 7cm 5-Fr PDS
IndomethacinDrug
All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.
| Study group | Role | What they receive |
|---|---|---|
| 5cm PDS group | Active comparator | All patients in this group receive 5cm 5-Fr PDS. Receives: Device: 5cm 5-Fr PDS; Drug: Indomethacin |
| 7cm PDS group | Experimental | All patients in this group receive 7cm 5-Fr PDS. Receives: Device: 7cm 5-Fr PDS; Drug: Indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP Pancreatitis
The diagnosis of PEP was established if there was new onset of upper abdominal pain associated with an increased serum amylase level of at least 3 times the upper limit of normal range at 24 hours after the procedure, and hospitalization for at least 2 nights.
Measured: 14 days
Secondary outcomes (2)
Moderate to severe PEP
The severity classification of pancreatitis was defined according to the criteria of Cotton et al and the revised Atlanta criteria.
Measured: 14 days
Other complications of ERCP
Other complications include post sphincterotomy bleeding, biliary infection, perforation, and any adverse outcomes possibly related to ERCP that required hospital admission or a prolonged hospital stay for further management.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start15 Oct 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP Acute PancreatitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (estimated)
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
- NCT04145336
- Sponsor's protocol ID
- KY20191010-2
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Domagk D, Oppong KW, Aabakken L, Czako L, Gyokeres T, Manes G, Meier P, Poley JW, Ponchon T, Tringali A, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Hassan C, Kaminski MF, Dinis-Ribeiro M, Rees CJ, Spada C, Valori R, Bisschops R, Rutter MD. Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2018 Nov;50(11):1116-1127. doi: 10.1055/a-0749-8767. Epub 2018 Oct 19.
PubMed 30340220Sugimoto M, Takagi T, Suzuki R, Konno N, Asama H, Sato Y, Irie H, Watanabe K, Nakamura J, Kikuchi H, Waragai Y, Takasumi M, Hikichi T, Ohira H. Pancreatic stents for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis should be inserted up to the pancreatic body or tail. World J Gastroenterol. 2018 Jun 14;24(22):2392-2399. doi: 10.3748/wjg.v24.i22.2392.
PubMed 29904246Olsson G, Lubbe J, Arnelo U, Jonas E, Tornqvist B, Lundell L, Enochsson L. The impact of prophylactic pancreatic stenting on post-ERCP pancreatitis: A nationwide, register-based study. United European Gastroenterol J. 2017 Feb;5(1):111-118. doi: 10.1177/2050640616645434. Epub 2016 Jul 8.
PubMed 28405329
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients: a Multicentre, Single-blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04145336
- Acronym / sponsor ID
- KY20191010-2
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- ERCP, PEP, Post-ERCP pancreatitis, Pancreatic duct stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 30 Oct 2019 (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.
Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) is estimated to be 10% to 15% in high-risk patients. Current guidelines recommend using pancreatic duct stent (PDS) for PEP prevention in high-risk patients, but it is not clear whether stent length will affect the effect of PEP prevention. The longer PDS will remain in the pancreatic duct for a longer period of time, thereby ensuring prolonged decompression with subsequent lowering of the risk for PEP. Findings from two retrospective studies showed that longer PDS was more effective in reducing the risk of post-ERCP hyperamylasemia and the frequency of PEP compared with the shorter PDS. We conducted this trial to test whether 7cm PDS was superior to 5cm PDS in PEP prevention in high-risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5cm PDS group | Active comparator | Device: 5cm 5-Fr PDS, Drug: IndomethacinAll patients in this group receive 5cm 5-Fr PDS. |
| 7cm PDS group | Experimental | Device: 7cm 5-Fr PDS, Drug: IndomethacinAll patients in this group receive 7cm 5-Fr PDS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Un-intentional pancreatic duct cannulation:
- Double-wire technique;
- High-risk patients:
- met at least 1 of the major criteria
- Clinical suspicion of sphincter of Oddi dysfunction;
Key exclusion criteria (5 listed)
- Therapeutic PDS;
- Acute pancreatitis within 3 days;
- With a history of pancreatic surgery or biliary-enteric anastomosis;
- Pregnant or breastfeeding women;
- unwilling or inability to provide consent.
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 |
|---|---|---|
| 5cm 5-Fr PDSHigh-risk patients receive 5cm 5-Fr PDS | Device | 5cm PDS group |
| 7cm 5-Fr PDSHigh-risk patients receive 7cm 5-Fr PDS | Device | 7cm PDS group |
| IndomethacinAll patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP. | Drug | 5cm PDS group, 7cm PDS group |
Primary outcome
Post-ERCP Pancreatitis
Time frame: 14 days
The diagnosis of PEP was established if there was new onset of upper abdominal pain associated with an increased serum amylase level of at least 3 times the upper limit of normal range at 24 hours after the procedure, and hospitalization for at least 2 nights.
2 secondary outcomes
Moderate to severe PEP
Time frame: 14 days
Other complications of ERCP
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Background: PubMed 30340220Domagk D, Oppong KW, Aabakken L, Czako L, Gyokeres T, Manes G, Meier P, Poley JW, Ponchon T, Tringali A, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Hassan C, Kaminski MF, Dinis-Ribeiro M, Rees CJ, Spada C, Valori R, Bisschops R, Rutter MD. Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2018 Nov;50(11):1116-1127. doi: 10.1055/a-0749-8767. Epub 2018 Oct 19.
- Background: PubMed 29904246Sugimoto M, Takagi T, Suzuki R, Konno N, Asama H, Sato Y, Irie H, Watanabe K, Nakamura J, Kikuchi H, Waragai Y, Takasumi M, Hikichi T, Ohira H. Pancreatic stents for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis should be inserted up to the pancreatic body or tail. World J Gastroenterol. 2018 Jun 14;24(22):2392-2399. doi: 10.3748/wjg.v24.i22.2392.
- Background: PubMed 28405329Olsson G, Lubbe J, Arnelo U, Jonas E, Tornqvist B, Lundell L, Enochsson L. The impact of prophylactic pancreatic stenting on post-ERCP pancreatitis: A nationwide, register-based study. United European Gastroenterol J. 2017 Feb;5(1):111-118. doi: 10.1177/2050640616645434. Epub 2016 Jul 8.
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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?
A study testing 5cm 5-Fr PDS, 7cm 5-Fr PDS and Indomethacin in people with Post-ERCP Acute Pancreatitis, 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 17 inclusion and 5 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 30 Oct 2019. 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?
Results are not available in the source record.
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?
Post-ERCP Pancreatitis (time frame: 14 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 NCT04145336, which also lists 3 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 30 Oct 2019.