Tiny stent may prevent pancreatitis after gallstone surgery
NCT ID NCT07495111
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether placing a small plastic tube (stent) in the pancreas during a gallstone removal procedure can prevent pancreatitis, a painful inflammation. 88 adults with both gallbladder and common bile duct stones will be randomly assigned to receive either standard care (anti-inflammatory medication) or the medication plus the stent. The main goal is to see if the stent reduces the number of people who develop pancreatitis after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prophylactic pancreatic stent
- What this could lead to
- If it works, this could provide a simple way to prevent a common complication (pancreatitis) after gallstone removal, making the procedure safer.
- What could go wrong
- This is a small, early-stage trial (88 people) comparing two approaches, so results may not apply to everyone. Stent placement itself carries a small risk of injury or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged 18 years or older; 2. Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI); 3. Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones; 4. Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP; 5. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm; 6. Patients with at least one of the following high-risk factors for post-ERCP pancreatitis (PEP): suspected sphincter of Oddi dysfunction (SOD), female sex, history of pancreatitis, difficult cannulation (defined as ≥5 cannulation attempts or ≥5 minutes of cannulation time), pancreatic duct contrast injection, age \<35 years, non-dilated extrahepatic bile duct, no history of chronic pancreatitis, normal serum bilirubin, precut sphincterotomy, biliary balloon dilation, incomplete bile duct stone clearance, or intraductal ultrasound ; 7. Patients who voluntarily provide signed informed consent. Exclusion Criteria: 1. Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome; 2. Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations; 3. Patients unfit for ERCP endoscopic treatment due to severe systemic diseases; 4. Patients with severe coagulation dysfunction (defined as an International Normalized Ratio \[INR\] \>1.5) or significant thrombocytopenia (platelet count \<50×10⁹/L); 5. Pregnant women; 6. Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure; 7. Patients with allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs); 8. Patients with congenital or acquired absence of the rectum; 9. Patients with severe acute pancreatitis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Qilu Hospital of Shandong University
RECRUITINGJinan, Shandong, 250063, China
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