Evaluating lidocaine's effect on preventing pancreatitis after ERCP surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital Privé des Peupliers
  Paris, France Recruiting

Study contacts

• Study coordinator: Gianfranco DONATELLI, MD
• Email: donatelligianfranco@gmail.com
• Phone: 01 44 16 52 00

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.