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Prevention study for Post ERCP Pancreatitis
Official title Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
ClinicalTrials.gov ID: NCT03713879
What this study is testing
What is Indomethacin?
Indomethacin is an investigational medicine, being studied as a potential treatment for post ercp pancreatitis.
Also referred to as indocid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- presence of one of the following risk factors for Post ERCP Pancreatitis
- sphincter of Oddi dysfunction
- history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy,
- difficult cannulation defined by \>5 cannulation attempts
- the use of double wire technique in bile duct access
You likely can't join if
- patients intended for pancreatic stenting e.g. those with pancreatic duct strictures, ampullectomy,
- without informed consents from patient or next of kin
- age \<18
- pregnant or lactating women
- patients with altered anatomy except except Billroth I and II gastrectomy
- contraindications to the use of NSAIDs such as those with active gastrointestinal bleeding, renal failure (serum creatinine \> 140)
See the full eligibility criteria
- presence of one of the following risk factors for Post ERCP Pancreatitis
- sphincter of Oddi dysfunction
- history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy,
- difficult cannulation defined by \>5 cannulation attempts
- the use of double wire technique in bile duct access
- at least 2 of the followings including i) female age\<50 ii) 3 pancreatograms iii) acinarization (contrast injection to tail fo pancreas). iv） normal bilirubin； v）guidewire to the tail of pancreas or secondary branches.
- patients intended for pancreatic stenting e.g. those with pancreatic duct strictures, ampullectomy,
- without informed consents from patient or next of kin
- age \<18
- pregnant or lactating women
- patients with altered anatomy except except Billroth I and II gastrectomy
- contraindications to the use of NSAIDs such as those with active gastrointestinal bleeding, renal failure (serum creatinine \> 140)
- known NSAID allergy
- incipient heart failure.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Hong Kong, Hong Kong, Hong Kong
- Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China; Shanghai, Shanghai Municipality, China; Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, China; Hong Kong, Hong Kong, Hong Kong; Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.