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NCT04661332: ERCP
Registry of Endoscopic Retrograde Cholangiopancreatographies Performed in Humans
trial in ERCP in 5,000 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 5,000 |
| Start date | 1 January 2016 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Italy |
Conditions studied
- ERCP — all drugs for ERCP →
Sponsor
Istituto Clinico Humanitas
Who can join
18 and older, any sex, with ERCP. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Treatment of the pathology of the extrahepatic biliary tract is the most frequent indication for performing endoscopic retrograde cholangiography (ERCP). The method, which combines endoscopic and radiological vision, also allows for therapeutic (and diagnostic) procedures on some pathologies of the pancreas and the papilla of Vater. During the maneuvers it is also possible to obtain cyto-histological material for the diagnosis of any lesions identified, through the execution of brushing. The endoscope used for ERCP allows for microsurgical procedures to be performed on the papilla of Vater, on the biliary tract and on the pancreas, procedures that in the past required a real surgical intervention. ERCP is a generally well tolerated procedure, but as with all medical procedures it can have limitations and be followed by some complications. In 5% of cases, the procedure may not be completed due to anatomical variants that do not allow the endoscope to reach the duodenum or to cannulate and visualize the bile and / or pancreatic ducts. The most frequent complication is acute pancreatitis, which can arise as a consequence of surgery on the common outlet of the biliary and pancreatic tracts; it occurs in 3-5% of cases and to date, it cannot be predicted or prevented in all cases. In some groups of patients (young, with non-dilated biliary tract, or with a history of previous pancreatitis) the risk of pancreatitis can reach 10-12% . In rare cases (less than 1%), pancreatitis can have a severe course and may require surgery. Other less frequent complications (with an overall incidence of less than 2%) are: infection of the biliary tract or cystic collections, bleeding resulting from papillo-sphincterotomy, and perforation of the duodenum or ducts. Infection and bleeding are generally treated medically or endoscopically; the perforation may require surgery in some cases. This registry aims to collect in a prospective and / or retrospective way the data of the ERCP procedures performed in our center by evaluating the sex, age of the patient, the reason why the patient was subjected to the examination, diagnosis, clinical risk factors and technical risk (i.e. associated with the procedure itself), if there have been complications, the type of instrumentation in use in our operating unit and / or the operators performing the examinations.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04661332
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for ERCP
Currently open trials in the same condition.
- NCT07368335 — Efficacy and Safety of a Novel ERCP Robot in the Treatment of Common Bile Duct Stone · NA · active not recruiting
- NCT07244432 — Post-ERCP Pancreatitis - Prophylactic Measures Implementation Study (PEP-PROMIS) · recruiting
- NCT07056075 — Prevention of Desaturations Using Positive Airway Pressure or Capnometry During ERCP · NA · recruiting
- NCT07071441 — Indomethacin vs Diclofenac for Preventing PEP · NA · recruiting
- NCT07130864 — Early vs Late Laparoscopic Cholecystectomy After Common Bile Duct Stones Clearance Through Ercp. · NA · recruiting
Other Istituto Clinico Humanitas trials
Trials by the same sponsor.
- NCT06944288 — Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination · NA · not yet recruiting
- NCT07358247 — Postoperative Outcomes of Single-stapled Anastomosis Combined With Transanal Natural Orifice Specimen Extraction · not yet recruiting
- NCT07362342 — RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery · not yet recruiting
- NCT07346274 — Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy. · enrolling by invitation
- NCT07491419 — The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04661332 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 14 September 2022
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