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

ConditionERCP Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intravenous lidocaine administration

    Drug

    General anesthesia with intravenous lidocaine administration

Treatment groups

1,800 Participants
are divided into 2 treatment groups
Group A: General anesthesia without intravenous lidocaine administrationNo intervention 0 interventions
Group B: General anesthesia with intravenous lidocaine administrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Hour 24

Secondary outcomes

1

Abdominal pain intensity

Assessment of abdominal pain on a simple numerical scale

Time frame
Hour 24
2

Pancreatic ultrasound or CT scan data

Pancreatic ultrasound or CT scan data if available

Time frame
Hour 24
3

Severity of pancreatitis

Severity of pancreatitis according to the ATLANTA 2012 criteria

Time frame
Hour 24

Other outcomes

Sponsors and contacts

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