Obstructive JaundiceARCHIMEDENCT03977779
Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
A study testing Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography in people with Obstructive Jaundice and Biliary Stricture, run by Institut Paoli-Calmettes at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Jaundice, Biliary Stricture, Sphincter of Oddi Dysfunction
- What is being tested?
- Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Jan 2022to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and/or patient-related risk factors
Who cannot join
- Pregnant or breastfeeding women
- Recent diagnosis (<1 month) of acute pancreatitis
- contraindication to endoscopy
- Hypersensitivity to indomethacine
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Paoli Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, 13009
Hôpital Beaujon AP-HP
Paris, 92110
About this study
Official title: Prospective Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
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.
- Being tested
- Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography
- Keywords
- biodegradable stent, Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
- Medical subject headings
- Jaundice, Obstructive, Sphincter of Oddi Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatographyDevice
The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic biodegradable pancreatic stent placement | Experimental | Not described Receives: Device: Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 30
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: DAY 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start20 Jan 2022
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977779
- Sponsor's protocol ID
- ARCHIMEDE-PANCREAS-IPC2018-052
- Acronym
- ARCHIMEDE
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
- ClinicalTrials.gov ID
- NCT03977779
- Acronym / sponsor ID
- ARCHIMEDE / ARCHIMEDE-PANCREAS-IPC2018-052
- Keywords
- biodegradable stent, Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 6 Jun 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prophylactic biodegradable pancreatic stent placement | Experimental | Device: Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18 years
- Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and/or patient-related risk factors
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Recent diagnosis (<1 month) of acute pancreatitis
- contraindication to endoscopy
- Hypersensitivity to indomethacine
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 |
|---|---|---|
| Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatographyThe ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography | Device | Prophylactic biodegradable pancreatic stent placement |
Primary outcome
Proportion of patients in whom placement of the ARCHIMEDES device for the prophylaxis of post-ERCP pancreatitis is a clinical success at Day 30
Time frame: 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
3 secondary outcomes
Safety
Time frame: DAY 45
Clinical Efficacy
Time frame: DAY 45
Technical Efficacy
Time frame: DAY 45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography in people with Obstructive Jaundice and Biliary Stricture, run by Institut Paoli-Calmettes at 2 sites in France.
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 4 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: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in whom placement of the ARCHIMEDES device for the prophylaxis of post-ERCP pancreatitis is a clinical success at Day 30 (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.