Evaluating lidocaine's effect on preventing pancreatitis after ERCP surgery
Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.
This study is testing if giving lidocaine during ERCP surgery can help prevent pancreatitis in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05667987 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of intravenous lidocaine in preventing post-ERCP pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). It involves a single-center, prospective, randomized, single-blind design with two groups: one receiving general anesthesia without lidocaine and the other with lidocaine. Both groups will receive standard preventive treatment with indomethacin, and various endoscopic techniques will be employed as needed. The primary outcome is the incidence of pancreatitis following the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for ERCP with a virgin papilla.
Not a fit: Patients with a sphincterotomized papilla or those under legal protection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of post-ERCP pancreatitis, improving patient outcomes.
How similar studies have performed: While the use of lidocaine in this context is being evaluated, similar studies have shown promising results in other settings, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years of age * Patient who has read and signed the consent form for participation in the study * Patient candidate for ERCP with virgin papilla Exclusion Criteria: * Patient with sphincterotomized papilla * Patient under court protection, guardianship or curatorship * Pregnant woman or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (\> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women after menarche and until they become postmenopausal, unless they are permanently infertile or have undergone surgical sterilization, are considered to be of childbearing age, i.e. fertile. A postmenopausal condition is defined as the absence of menstruation for 12 months without any other medical cause * Patient not affiliated with the French social security system * Patient participating in another clinical research protocol * Impossibility to give the subject informed information and/or written informed consent: dementia, psychosis, disorders of consciousness, non-French speaking patient * Contraindication to the use of NSAIDs * Contraindication to anesthesia or to the administration of any of the products used in anesthesia protocols (including lidocaine)
Where this trial is running
Paris
- Hôpital Privé des Peupliers — Paris, France (Recruiting)
Study contacts
- Study coordinator: Gianfranco DONATELLI, MD
- Email: donatelligianfranco@gmail.com
- Phone: 01 44 16 52 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.