An interventional study of Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography in Obstructive Jaundice, Biliary Stricture and Sphincter of Oddi Dysfunction, sponsored by Institut Paoli-Calmettes. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Prevention
The use of an endoprothesis in a pancreatic duct is a measure to minimize the incidence and severity of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis. In this study we will evaluate the use of a Biodegradable Endoprothesis: Archimede Fast Biodegradable Pancreatic Stent in patients with high risk of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis.The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography. The efficacy and the security of the device will be evaluated.
62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.
This study's enrollment of 46 is below the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →Institut Paoli-Calmettes is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography
The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography
Proportion of patients in whom placement of the ARCHIMEDES device for the prophylaxis of post-ERCP pancreatitis is a clinical success at Day 30
Proportion of patients in whom placement of the ARCHIMEDES device for the prophylaxis of post-ERCP pancreatitis is a clinical success at Day 30, defined as the proportion of patients: With all available imaging assessments demonstrating complete degradation of the pancreatic stent, including: The abdominal radiograph scheduled as part of the study; Any other radiographic examination or imaging procedure performed for reasons unrelated to the study that allows visualization of the abdomen; or Undergoing a repeat endoscopic procedure demonstrating complete degradation of the stent; or With all available imaging assessments showing incomplete degradation of the stent, not associated with symptoms of acute pancreatitis within 30 days following ERCP. Post-ERCP acute pancreatitis is defined by the presence of at least two of the following three criteria: (i) Typical abdominal pain (acute onset of persistent epigastric pain, often radiating to the back); (ii) Serum lipase level at lea
Time frame: Day 30
Safety
Proportion of patients experiencing at least one procedure-related complication of Clavien-Dindo grade 3, 4, or 5 within 24 hours after the procedure, including: Bleeding, perforation (biliary, pancreatic, or duodenal), or stent misplacement; Fever. All-cause mortality within 45 days following ERCP; Proportion of patients with early stent migration (stent migration at 24 hours, confirmed by plain abdominal radiography); Proportion of patients requiring endoscopic stent removal. Stent removal will be considered in cases of complete absence of degradation or incomplete degradation associated with symptoms related to stent retention lasting ≥ 45 days. Stent removal will be performed at the investigator's discretion.
Time frame: DAY 45
Clinical Efficacy
Proportion of patients developing acute pancreatitis, classified as mild, moderate, severe, or critical according to the classification of Dellinger et al., 2012, within 45 days following ERCP
Time frame: DAY 45
Technical Efficacy
Proportion of patients in whom ARCHIMEDES device placement is a technical success, defined as successful endoscopic placement of the stent on the first attempt.
Time frame: DAY 45
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.