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NCT01758549 · ClinicalTrials.gov registry record · NA
Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT01758549: Completed NA study, sponsored by University of Southern California.
NCT01758549 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01758549, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study Summary
1. ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of the bile duct as well as to manage leaks which occurs following laparoscopic gallbladder removal. 2. Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and results in considerable suffering and cost. 3. Patients with acute pancreatitis are treated with fluids. 4. Our aim is to assess whether prophylactic treatment with aggressive intravenous hydration prevents ERCP pancreatitis. 5. In a blinded fashion patients will be randomized to aggressive intravenous versus moderate hydration during and aftere ERCP for standard clinical indications. Our hypothesis is that prophylactic treatment with aggressive intravenous hydration protects against ERCP pancreatitis.
Primary Outcome
The primary endpoint is post ERCP pancreatitis which is defined as increased abdominal pain and a serum amylase level three times the upper limit of normal (3xULN). Increased pain will be defined as an increase in the visual analog pain score compared to the value immediately prior to ERCP
Interventions
- OTHER Aggressive Intravenous Hydration Group
- OTHER Standard Fluids Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01758549 record still lists
NCT01758549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Aggressive Intravenous Hydration Group is the first listed.
NCT01758549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01758549 about?
NCT01758549 is a clinical study titled "Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis". 1. ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of the bile duct as well as to manage leaks which occurs following laparoscopic gallbladder removal. 2. Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and results in considerable ...
What is the current status of trial NCT01758549?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2012-07. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01758549?
The interventions under investigation include: Aggressive Intravenous Hydration Group (OTHER), Standard Fluids Arm (OTHER).
Who is sponsoring clinical trial NCT01758549?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01758549's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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