ERCP SurgeryPEPLIDNCT05667987
Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.
A study testing Intravenous lidocaine administration in people with ERCP Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERCP Surgery
- What is being tested?
- Intravenous lidocaine administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé des Peupliers
Paris, 75013
Gianfranco DONATELLI, MD, 01 44 16 52 00 ext. 33, donatelligianfranco@gmail.com
Gianfranco Gianfranco, MD
About this study
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
Read the 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).
- Conditions
- ERCP Surgery
- Being tested
- Intravenous lidocaine administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous lidocaine administrationDrug
General anesthesia with intravenous lidocaine administration
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia without intravenous lidocaine administration | No intervention | Not described |
| General anesthesia with intravenous lidocaine administration | Experimental | Not described Receives: Drug: Intravenous lidocaine administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Hour 24
Secondary outcomes (3)
Abdominal pain intensity
Assessment of abdominal pain on a simple numerical scale
Measured: Hour 24
Pancreatic ultrasound or CT scan data
Pancreatic ultrasound or CT scan data if available
Measured: Hour 24
Severity of pancreatitis
Severity of pancreatitis according to the ATLANTA 2012 criteria
Measured: Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start18 Jan 2024
- Primary completion18 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCP SurgeryStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667987
- Sponsor's protocol ID
- 2022-A01658-35
- Acronym
- PEPLID
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.
- ClinicalTrials.gov ID
- NCT05667987
- Acronym / sponsor ID
- PEPLID / 2022-A01658-35
- Conditions
- ERCP Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 18 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia without intravenous lidocaine administration | No intervention | – |
| General anesthesia with intravenous lidocaine administration | Experimental | Drug: Intravenous lidocaine administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous lidocaine administrationGeneral anesthesia with intravenous lidocaine administration | Drug | General anesthesia with intravenous lidocaine administration |
Primary outcome
Plasma lipase level
Time frame: Hour 24
A plasma lipase level greater than or equal to 3N, considered to be indicative of a PAP, is the primary endpoint of the study
3 secondary outcomes
Abdominal pain intensity
Time frame: Hour 24
Pancreatic ultrasound or CT scan data
Time frame: Hour 24
Severity of pancreatitis
Time frame: Hour 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous lidocaine administration in people with ERCP Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianfranco DONATELLI, MD (01 44 16 52 00 ext. 33, donatelligianfranco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma lipase level (time frame: Hour 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.