Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
Observational · No treatment assigned · Sites not listed yet · Germans Trias i Pujol Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Choledocholithiasis, Choledocholithiasis With Acute Cholangitis and Cholangiocarcinoma. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- All consecutive patients who have undergone an ERCP at participating centres from 1 November 2024 will be included. An ERCP will be considered to have been performed when an endoscope is introduced to access the duodenal papilla.
- These included patients must meet all of the following criteria:
- Over 18 years of age
- Signed informed consent.
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 3000 participants are expected to take part.
- The study has 1 group.
- Start date: 2024-11-01 (planned).
- Main results expected around 2025-10-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- Patients with biliopancreatic pathology undergoing ERCP
Main thing being measured
- To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry (Patients receiving antibiotic prophylaxis of at least one dose of any systemic antibiotic in a 12-hour interval prior…)
- To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry. (Patients in whom biliary cannulation is achieved up to 1 hour after completion of ERCP.)
- To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry. (Patients who successfully placed stents in obstructions distal to the hilum up to 1 hour after completion of ERCP.)
In the researchers’ words
Endoscopic retrograde cholangiopancreatography (ERCP) is a technique which combines endoscopic and radiological vision and allows for therapeutic procedures on pathologies of the pancreas and bile duct. ERCP is a generally well tolerated procedure, nonetheless it is a complex technique that has a higher frequency of complications compared to most endoscopic procedures that can even be life-threatening. These…
Words you might see
- ERCP: a procedure using a scope and dye to look at (and sometimes treat) the bile ducts.
- Endoscopy: a camera exam inside the digestive tract.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Choledocholithiasis; Choledocholithiasis With Acute Cholangitis; Cholangiocarcinoma; Sclerosing Cholangitis; Pancreatic Cancer Resectable; Pancreatic Cancer Non-resectable; Biliary Fistula |
| Lead sponsor | Germans Trias i Pujol Hospital |
| Collaborators | Spanish Society of Digestive Endoscopy |
| Enrollment | 3000 (estimated) |
| Start date | 2024-11-01 |
| Primary completion (est.) | 2025-10-30 |
| First posted | 2024-11-01 |
| Last updated | 2024-11-01 |
| Official title | Prospective and Multicenter Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography |
| ClinicalTrials.gov ID | NCT06670547 |
Interventions
- Endoscopic retrograde cholangiopancreatography (ERCP) (Procedure)
Endoscopic retrograde cholangiopancreatography (ERCP)
Full eligibility criteria (from the record)
Inclusion Criteria: All consecutive patients who have undergone an ERCP at participating centres from 1 November 2024 will be included. An ERCP will be considered to have been performed when an endoscope is introduced to access the duodenal papilla. These included patients must meet all of the following criteria: * Over 18 years of age * Signed informed consent. Exclusion Criteria: * Under 18 years of age * Unavailability of informed consent * Impossibility of follow-up.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.