About this trial
The goal of this study is, in a population of patients undergoing ERCP surgery, treated preventively with NSAIDs and divided into two groups according to the absence (group 1) or presence (group 2) of intravenous lidocaine in the general anesthesia protocol.
The main objective of this study is to compare the incidence of post-ERCP pancreatitis between the two groups.
type of study: clinical trial participant population/health conditions: Patients with ERCP surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Intravenous lidocaine administration
DrugGeneral anesthesia with intravenous lidocaine administration
Treatment groups
Trial outcomes
Primary outcomes
Plasma lipase level
A plasma lipase level greater than or equal to 3N, considered to be indicative of a PAP, is the primary endpoint of the study
Secondary outcomes
Abdominal pain intensity
Assessment of abdominal pain on a simple numerical scale
Pancreatic ultrasound or CT scan data
Pancreatic ultrasound or CT scan data if available
Severity of pancreatitis
Severity of pancreatitis according to the ATLANTA 2012 criteria
Sponsors and contacts
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