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

NCT05667987 | Recruiting

• 1 other identifier: 2022-A01658-35
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

ERCP Surgery

Outcome Measures

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

  Hour 24

Secondary Outcomes (3)

• Abdominal pain intensity

  Hour 24

• Pancreatic ultrasound or CT scan data

  Hour 24

• Severity of pancreatitis

  Hour 24

Study Arms (2)

General anesthesia without intravenous lidocaine administration

NO INTERVENTION

General anesthesia with intravenous lidocaine administration

EXPERIMENTAL

Drug: Intravenous lidocaine administration

Interventions

Intravenous lidocaine administration DRUG

General anesthesia with intravenous lidocaine administration

General anesthesia with intravenous lidocaine administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé des Peupliers

Paris, 75013, France

RECRUITING

Central Study Contacts

Gianfranco DONATELLI, MD

CONTACT

01 44 16 52 00; donatelligianfranco@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 29, 2022
• Study Start: January 18, 2024
• Primary Completion: January 18, 2026
• Study Completion: February 28, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)