Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Dec 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medication called lidocaine to the anesthesia used during a specific procedure called endoscopic retrograde cholangiopancreatography (ERCP) can help prevent a common complication known as post-ERCP pancreatitis. In this trial, patients who are scheduled for ERCP will receive either standard care with lidocaine or standard care without it, and researchers will compare how many patients in each group develop pancreatitis afterward.

To participate in this study, you must be at least 18 years old, able to give informed consent, and scheduled for an ERCP procedure with an untouched papilla (the opening where the bile and pancreatic ducts meet). However, certain individuals may not be eligible, such as those who are pregnant, have had previous surgery in the same area, or have specific health conditions that prevent them from safely receiving anesthesia or non-steroidal anti-inflammatory drugs (NSAIDs). If you decide to join, you can expect careful monitoring during the ERCP and follow-up to assess your health afterward. This study is currently recruiting participants, and your involvement could help improve patient care for others undergoing this procedure in the future.

Gender

ALL

Eligibility 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)