Post-ERCP Acute PancreatitisNCT07117318
Rectal NSAIDs With/Without PD Stent for PEP Prevention
A study testing NSAIDs and NSAIDs plus PDS in people with Post-ERCP Acute Pancreatitis and Non-steroid Anti-inflammatory Drugs, run by Air Force Military Medical University, China at 15 sites in China.
Trial summary
Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis, Non-steroid Anti-inflammatory Drugs, Pancreatic Duct Stent Placement
- What is being tested?
- NSAIDs and NSAIDs plus PDS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,278 participants
- Where
- 15 sitesChina
- Study dates
- 1 Jul 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 18-90 years old patients with native papilla who planned to undergo ERCP
- high-risk patients for post-ERCP pancreatitis must meet one or more following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation (>5 cannulation attempts, or >5mins cannulation time, or >1 unintentional pancreatic duct cannulation), or ballon dilatation of an intact biliary sphincter ≤ 1 min, double-wire cannulation. Additionally, patients were considered high-risk if they fulfilled two or more of the following minor criteria: female gender under 50 years old, a history of recurrent pancreatitis (two or more episodes), three or more contrast injections into the pancreatic duct with at least one injection reaching the tail of the pancreas, opacification of pancreatic acini, or brush cytology performed on the pancreatic duct.
Who cannot join
- Previous biliary sphincterotomy and papillary large balloon dilation
- Planned for placements of pancreatic duct stents (eg. pancreatic duct strictures, planned ampullectomy)
- Allergy to NSAIDs
- The administration of NSAIDs within 7 days
- Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
- Acute pancreatitis within 7 days before ERCP or acute pancreatitis with obvious Pancreatic edema and peripancreatic fluid collections
Show all 9Show fewer
- Hemodynamical instability
- Pregnancy or lactation
- high-risk patients with pancreatic duct wire passages
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Not yet recruiting
The first medical center, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Yaqi Zhai, 86-13810105934, astaring@163.com
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Zhao Lei, 86-13469438509, leizhao1987@outlook.com
- Recruiting
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Bo Ning, M.D., +8613996476336, ningbo.bo@163.com
Bo Ning, M.D.
- Not yet recruiting
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000
Xiaofeng Zhang, 86-13758250208, zhangxiaofeng@hospital.westlake.edu.cn
- Recruiting
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Kangjie Chen, 86-18989487755, ckj_zyyy@zju.edu.cn
- Recruiting
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, 150000
Liguo Wang, 86-13654553324, wangliguo8314000@sina.com
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Lei Zhao, 86-18745143401, zhaolei181220@163.com
- Recruiting
Department of Gastroenterology, The 960th Hospital of the PLA
Jinan, Shandong, 250000
Xiaofeng Liu, 86-13969179611, dolphinj228@hotmail.com
- Not yet recruiting
Shandong Provincial Third Hospital
Jinan, Shandong, 250000
Ming zhang, 86-13791112618, mklaolong@163.com
- Recruiting
Department of Gastroenterology, Huaihe Hospital of Henan University
Kaifeng, Henan, 475000
Jianghai Zhao, MD, +8615191903630, 493109907@qq.com
- Recruiting
Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 201823
Mingxing Xia, MD, 13906524284, xiamingxing1982@126.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Bing Wang, 86-13307171656, 2013tj0575@just.edu.cn
- Recruiting
986 Hospital of Xijing Hospital
Xi'an, Shaanxi, 710000
Jun Wang, 86-13669252896, wangjundoctor@aliyun.com
- Recruiting
Xijing of Digestive Diseases
Xi'an, Shaanxi
Yang lin Pan, MD, 862984771536, yanglinpan@hotmail.com
- Recruiting
Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
Xiamen, Fujian, 361000
Rongchun Zhang, +8613720892152, Zrc.700502@163.com
About this study
Official title: Rectal Non-steroid Anti-inflammatory Drugs With or Without Prophylactic Pancreatic Duct Stent for Prevention of Post-ERCP Pancreatitis: a Multicenter, Randomized, Non-inferiority Trial
Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and pancreatic duct stent (PDS) placement were demonstrated to be effective strategyies to reduce PEP incidences, particlularly in high-risk patients for post-ERCP pancreatitis (PEP).
Rectal NSAIDs were easy-to-use and safe, while PDS placement were technically complex and carried higher risks of adverse events. A previous network meta-analysis suggested rectal NSAIDs in combination with PDS placement did not differ from rectal NSAIDs alone in PEP prevention. To invesigate if rectal NSAIDs alone could obivate the need of PDS placement, a recent trial from Elmunzer et al. conducted a randomized trial to investigate if rectal NSAIDs alone was non-inferior to the combination of NSAIDs with PDS in high-risk patients. The trial found that the PEP incidence rate in combination group was significantly lower than that in NSAIDs alone group. However, post-hoc analysis of the study suggested that the combination strategy conferred significant benefits only in high-risk patients with pancreatic duct (PD) wire passage, but not in those with other risk factors. Therefore, we hypothesized that rectal NSAIDs alone may obivate the need of PDS in high-risk patients without PD wire passages. Here, we conducted a multicenter, randomized and non-inferiority trial to investigate whether rectal NSAIDs alone is non-inferior to NSAIDs plus PDS placement in high-risk patients without PD wire passages.
- Conditions
- Post-ERCP Acute Pancreatitis, Non-steroid Anti-inflammatory Drugs, Pancreatic Duct Stent Placement
- Being tested
- NSAIDs, NSAIDs plus PDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDsDrug
All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure
NSAIDs plus PDSDevice
All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure. When eligibility is met, PDS placement will be performed by ERCP colonoscopists.
| Study group | Role | What they receive |
|---|---|---|
| NSAIDs alone | Experimental | All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure Receives: Drug: NSAIDs |
| NSAIDs plus PDS | Active comparator | All patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure. When eligibility is met, PDS placement will be performed by ERCP colonoscopists. Receives: Device: NSAIDs plus PDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-ERCP Pancreatitis
a new or aggravated upper abdominal pain, with an elevated pancreatic enzyme of at least 3 times as the upper limit of normal value 24h after procedure and prolonged hospitalization days for at least 2 days. This definition was based on a widely recognized Cotton consensus
Measured: 30 days
Secondary outcomes (7)
Rate of mild, moderate or severe PEP
The severity classification of post-ERCP pancreatitis was defined according to the Cotton Criteria. Mild PEP: with an extension of hospitalization period of 2-3 days; Moderate PEP: with an extension of hospitalization period of 4-10 days; Severe PEP: with an extension of more than 10 days, or hemorrhagic pancreatitis, phlegmon, or pseudocyst, intervention (percutaneous drainage or surgery), or death.
Measured: 30 days
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
Mild: The most common form of acute pancreatitis, without organ failure or local or systemic complications, generally resolving within 1 week of onset. Moderately Severe: the presence of transient organ failure, local complications or exacerbation of co-morbid disease.
Severe: persistent organ failure, that is, organ failure >48 h. Local complications are peripancreatic fluid collections, pancreatic and peripancreatic necrosis (sterile or infected), pseudocyst and walled-off necrosis (sterile or infected).
Measured: 30 days
Rate of ERCP-related perforation
Perforation was established according to Cotton criteria, Mild: slight leakage of fluid or contrast dye, manageable through fluid administration and suction therapy ≤3 days Moderate: definite perforation required to be managed for 4-10 days Severe: management for more than 10 days or requiring for percutaneous or surgical intervention.
Measured: 30 days
Rate of ERCP-related infection
Infection was established according to Cotton criteria. Mild: temperature >38# for 24-48h Moderate: Febrile illness requiring >3 days of hospital treatment; endoscopic or percutaneous interventions; Severe: septic shock or requiring surgery.
Measured: 30 days
Rate of ERCP-related bleeding
Bleeding was established according to Cotton criteria. Mild: a documented decrease in hemoglobin concentration by <3 g/L, without requiring the blood transfusion; Moderate: blood transfusion ≤4 units; without need for angiographic or surgery interventions Severe: Transfusion: ≥5 units or requiring for angiographic or surgery interventions.
Measured: 30 days
The rate of total adverse events
Adverse events include ERCP-related or non ERCP-related adverse events
Measured: 30 days
The rate of successful pancreatic duct stent placements
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,278 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
- NCT07117318
- Sponsor's protocol ID
- KY20252177-F-1
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440Elmunzer BJ, Foster LD, Serrano J, Cote GA, Edmundowicz SA, Wani S, Shah R, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Papachristou GI, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen B, Wang AY, Saltzman JR, Spitzer RL, Ordiah C, Spino C, Durkalski-Mauldin V; SVI Study Group. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial. Lancet. 2024 Feb 3;403(10425):450-458. doi: 10.1016/S0140-6736(23)02356-5. Epub 2024 Jan 11.
PubMed 38219767Han S, Zhang J, Durkalski-Mauldin V, Foster LD, Serrano J, Cote GA, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Groce JR, Lee PJ, Krishna SG, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Wani S, Edmundowicz SA, Shah RJ, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen BT, Wang AY, Saltzman JR, Spitzer RL, Spino C, Elmunzer BJ, Papachristou GI; SVI Study Group. Impact of difficult biliary cannulation on post-ERCP pancreatitis: secondary analysis of the stent versus indomethacin trial dataset. Gastrointest Endosc. 2025 Mar;101(3):617-628. doi: 10.1016/j.gie.2024.10.003. Epub 2024 Oct 9.
PubMed 39389431Akbar 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 23376320Halttunen J, Keranen I, Udd M, Kylanpaa L. Pancreatic sphincterotomy versus needle knife precut in difficult biliary cannulation. Surg Endosc. 2009 Apr;23(4):745-9. doi: 10.1007/s00464-008-0056-0. Epub 2008 Jul 23.
PubMed 18649101
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Non-steroid Anti-inflammatory Drugs With or Without Prophylactic Pancreatic Duct Stent for Prevention of Post-ERCP Pancreatitis: a Multicenter, Randomized, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07117318
- Acronym / sponsor ID
- KY20252177-F-1
- Conditions
- Post-ERCP Acute Pancreatitis, Non-steroid Anti-inflammatory Drugs, Pancreatic Duct Stent Placement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,278 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 12 Aug 2025 (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.
Pancreatitis is the most common and serious complication following post-endoscopic retrograde cholangiopancreatography (ERCP) and is associated with occasional mortality, extended hospital stays, and increased healthcare expenses. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and pancreatic duct stent (PDS) placement were demonstrated to be effective strategyies to reduce PEP incidences, particlularly in high-risk patients for post-ERCP pancreatitis (PEP).
Rectal NSAIDs were easy-to-use and safe, while PDS placement were technically complex and carried higher risks of adverse events. A previous network meta-analysis suggested rectal NSAIDs in combination with PDS placement did not differ from rectal NSAIDs alone in PEP prevention. To invesigate if rectal NSAIDs alone could obivate the need of PDS placement, a recent trial from Elmunzer et al. conducted a randomized trial to investigate if rectal NSAIDs alone was non-inferior to the combination of NSAIDs with PDS in high-risk patients. The trial found that the PEP incidence rate in combination group was significantly lower than that in NSAIDs alone group. However, post-hoc analysis of the study suggested that the combination strategy conferred significant benefits only in high-risk patients with pancreatic duct (PD) wire passage, but not in those with other risk factors. Therefore, we hypothesized that rectal NSAIDs alone may obivate the need of PDS in high-risk patients without PD wire passages. Here, we conducted a multicenter, randomized and non-inferiority trial to investigate whether rectal NSAIDs alone is non-inferior to NSAIDs plus PDS placement in high-risk patients without PD wire passages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAIDs alone | Experimental | Drug: NSAIDsAll patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure |
| NSAIDs plus PDS | Active comparator | Device: NSAIDs plus PDSAll patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure. When eligibility is met, PDS placement will be performed by ERCP colonoscopists. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-90 years old patients with native papilla who planned to undergo ERCP
- high-risk patients for post-ERCP pancreatitis must meet one or more following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, difficult cannulation (>5 cannulation attempts, or >5mins cannulation time, or >1 unintentional pancreatic duct cannulation), or ballon dilatation of an intact biliary sphincter ≤ 1 min, double-wire cannulation. Additionally, patients were considered high-risk if they fulfilled two or more of the following minor criteria: female gender under 50 years old, a history of recurrent pancreatitis (two or more episodes), three or more contrast injections into the pancreatic duct with at least one injection reaching the tail of the pancreas, opacification of pancreatic acini, or brush cytology performed on the pancreatic duct.
Key exclusion criteria (9 listed)
- Previous biliary sphincterotomy and papillary large balloon dilation
- Planned for placements of pancreatic duct stents (eg. pancreatic duct strictures, planned ampullectomy)
- Allergy to NSAIDs
- The administration of NSAIDs within 7 days
- Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
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 |
|---|---|---|
| NSAIDsAll patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure | Drug | NSAIDs alone |
| NSAIDs plus PDSAll patients without contraindications should receive 100mg rectal indomethacin or diclofenac within 30mins before ERCP procedure. When eligibility is met, PDS placement will be performed by ERCP colonoscopists. | Device | NSAIDs plus PDS |
Primary outcome
Rate of post-ERCP Pancreatitis
Time frame: 30 days
a new or aggravated upper abdominal pain, with an elevated pancreatic enzyme of at least 3 times as the upper limit of normal value 24h after procedure and prolonged hospitalization days for at least 2 days. This definition was based on a widely recognized Cotton consensus
7 secondary outcomes
Rate of mild, moderate or severe PEP
Time frame: 30 days
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
Time frame: 30 days
Rate of ERCP-related perforation
Time frame: 30 days
Rate of ERCP-related infection
Time frame: 30 days
Rate of ERCP-related bleeding
Time frame: 30 days
The rate of total adverse events
Time frame: 30 days
The rate of successful pancreatic duct stent placements
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Background: PubMed 38219767Elmunzer BJ, Foster LD, Serrano J, Cote GA, Edmundowicz SA, Wani S, Shah R, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Papachristou GI, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen B, Wang AY, Saltzman JR, Spitzer RL, Ordiah C, Spino C, Durkalski-Mauldin V; SVI Study Group. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial. Lancet. 2024 Feb 3;403(10425):450-458. doi: 10.1016/S0140-6736(23)02356-5. Epub 2024 Jan 11.
- Background: PubMed 39389431Han S, Zhang J, Durkalski-Mauldin V, Foster LD, Serrano J, Cote GA, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Groce JR, Lee PJ, Krishna SG, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Wani S, Edmundowicz SA, Shah RJ, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen BT, Wang AY, Saltzman JR, Spitzer RL, Spino C, Elmunzer BJ, Papachristou GI; SVI Study Group. Impact of difficult biliary cannulation on post-ERCP pancreatitis: secondary analysis of the stent versus indomethacin trial dataset. Gastrointest Endosc. 2025 Mar;101(3):617-628. doi: 10.1016/j.gie.2024.10.003. Epub 2024 Oct 9.
- 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.
- Background: PubMed 18649101Halttunen J, Keranen I, Udd M, Kylanpaa L. Pancreatic sphincterotomy versus needle knife precut in difficult biliary cannulation. Surg Endosc. 2009 Apr;23(4):745-9. doi: 10.1007/s00464-008-0056-0. Epub 2008 Jul 23.
- Individual participant dataSharing planned: Undecided
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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.
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
Xiamen, China
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAIDs and NSAIDs plus PDS in people with Post-ERCP Acute Pancreatitis and Non-steroid Anti-inflammatory Drugs, run by Air Force Military Medical University, China at 15 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 9 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-ERCP Pancreatitis (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 NCT07117318, which also lists 5 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 3 Dec 2025.