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RecruitingNot ApplicableNCT05667987

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

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrollment

1,800 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

ERCP Surgery

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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)
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Interventions

DRUGIntravenous lidocaine administration

General anesthesia with intravenous lidocaine administration

Locations(1)

Hôpital Privé des Peupliers

Paris, France

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NCT05667987