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

Primary Purpose

ERCP Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intravenous lidocaine administration
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ERCP Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Privé des Peupliers

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

General anesthesia without intravenous lidocaine administration

General anesthesia with intravenous lidocaine administration

Arm Description

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
December 19, 2022
Last Updated
December 19, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05667987
Brief Title
Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.
Acronym
PEPLID
Official Title
Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
This is a single-center, prospective, randomized, single-blind study of two parallel groups of patients undergoing ERCP surgery Group 1 (n=900): General anesthesia without IV lidocaine administration Group 2 (n=900): General anesthesia with IV lidocaine administration Randomization Patients who have given written informed consent and received confirmation of eligibility will be randomized into the study according to a randomization list. According to the randomization, patients will be divided into two equal groups of 900 patients (anesthesia with and without lidocaine). The randomization list will be established by a centralized computer procedure. PAP prevention protocols Treatment with indomethacin (100mg intrarectally), which is the reference preventive treatment, will be administered systematically in both groups just before anesthesia (or during anesthesia if ERCP is preceded by an echo-endoscopy). The endoscopic techniques to prevent PAP (pancreatic prosthesis, double guide wire technique, infundibulotomy, needle pre-cutting ...) will be used by the operator according to his procedural habits and will be reported in the CRF. Anesthesia protocol All patients will be operated under general anesthesia with orotracheal intubation without premedication with the same anesthesia protocol: At induction: a hypnotic (propofol or hypnomidate) combined with a morphine (sufentanil or remifentanyl) and low doses of Ketamine and midazolam, with or without curarization. In maintenance phase sevoflurane. Blood pressure will be maintained by administration of ephedrine, neosynephrine or baby noradrenaline. The patient's hydration will be ensured by an infusion of Ringer Lactate (20ml/Kg). In the postoperative period, analgesic treatment will be systematically administered with, according to the needs, palliative analgesics 1 or 2 or morphine titration. Lidocaine administration protocol Patients randomized in group 2 will receive during anesthesia a treatment with 1% non-adrenalized Lidocaine. An initial bolus (1.5mg/kg) will be administered at induction of anesthesia (or upon ERCP decision if echo-endoscopy is in progress). Then IVSE of lidocaine at 2mg/Kg/hr will be started for one hour (to be continued in the ICU if needed).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERCP Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia without intravenous lidocaine administration
Arm Type
No Intervention
Arm Title
General anesthesia with intravenous lidocaine administration
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intravenous lidocaine administration
Intervention Description
General anesthesia with intravenous lidocaine administration
Primary Outcome Measure Information:
Title
Plasma lipase level
Description
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 Outcome Measure Information:
Title
Abdominal pain intensity
Description
Assessment of abdominal pain on a simple numerical scale
Time Frame
Hour 24
Title
Pancreatic ultrasound or CT scan data
Description
Pancreatic ultrasound or CT scan data if available
Time Frame
Hour 24
Title
Severity of pancreatitis
Description
Severity of pancreatitis according to the ATLANTA 2012 criteria
Time Frame
Hour 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianfranco DONATELLI, MD
Phone
01 44 16 52 00
Ext
33
Email
donatelligianfranco@gmail.com
Facility Information:
Facility Name
Hôpital Privé des Peupliers
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianfranco DONATELLI, MD
Phone
01 44 16 52 00
Ext
33
Email
donatelligianfranco@gmail.com
First Name & Middle Initial & Last Name & Degree
Gianfranco Gianfranco, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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