Condition category
Digestive System
Date applied
04/03/2015
Date assigned
18/05/2015
Last edited
17/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Every year 17,000 endoscopic retrograde cholangiopancreatographies (ERCP) are performed in the Netherlands. ERCP is a procedure to evaluate and treat conditions concerning the bile duct. The most common complication is post-ERCP pancreatitis (PEP), occurring in 3%-16% of patients undergoing the procedure. PEP leads to prolonged hospitalization with substantial economic impact. Rectal anti-inflammatory drugs carry the most solid evidence in decreasing the PEP rate and this is the current standard of care according to the European Society of Gastrointestinal Endoscopy guideline. A new strategy to prevent PEP was tested in a study which compared standard intravenous (IV) fluid administration with an aggressive rehydration protocol with Ringer’s lactate (RL, a type of infusion fluid). However, the limitations of the study were the small number of patients involved and the fact that none of them received anti-inflammatory drugs. The aim of this study is to investigate the value of peri-ERCP hydration with RL on top of standard care, including anti-inflammatory drugs.

Who can participate?
Patients between 18 and 85 years of age undergoing ERCP with a moderate-severe risk for developing PEP

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives intensive RL hydration in addition to rectal anti-inflammatory drugs. The other group receives no or mild hydration with normal saline (salt water) in addition to rectal anti-inflammatory drugs (the standard of care). Participants have the following tests: blood sampling, body measurements and a questionnaire (15-30 min) at 30, 90 and 180 days after the procedure.

What are the possible benefits and risks of participating?
Possible risks are associated with overhydration (i.e. pulmonary edema, ankle edema). However, considering the total volume of fluids used and the exclusion of patients prone to this complication, the risk should be very low. It must be stressed that there is no standard infusion rate, volume and type of fluid, in the peri-ERCP setting. The two regimens proposed in this study are within the range daily common practice use.

Where is the study run from?
A number of hospitals in the Netherlands

When is the study starting and how long is it expected to run for?
April 2015 to November 2016

Who is funding the study?
1. Radboud University Medical Center
2. Netherlands Organisation for Health Research and Development

Who is the main contact?
Dr Erwin van Geenen
erwin.vangeenen@radboudumc.nl

Trial website

https://www.fluyt-trial.nl/

Contact information

Type

Scientific

Primary contact

Dr Erwin van Geenen

ORCID ID

Contact details

Radboud University Medical Center
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
(024) 361 47 60
erwin.vangeenen@radboudumc.nl

Additional identifiers

EudraCT number

2015-000829-37

ClinicalTrials.gov number

Protocol/serial number

Version 2 (dated 09/03/2015)

Study information

Scientific title

Fluid Hydration to prevent Post-Endoscopic retrograde cholangiopancreatography Pancreatitis

Acronym

FLUYT-prevent

Study hypothesis

Peri-procedural intensive lactated Ringer's solution hydration on top of rectal non-steroid anti-inflammatory drugs will reduce the incidence of post-ERCP pancreatitis (PEP) in a moderate-to-high risk population, and may even reduce the percentage of severe PEP.

Ethics approval

On the 14/04/2015, the Medical research Ethics Committees United (MEC-U) gave a positive verdict for the trial. Also, as a Competent Authority for the review of clinical trials in the Netherlands, the CCMO has performed a marginal assessment of the clinical trial. The Competent Authority found no objection against execution of the trial within the Netherlands. This verdict was given on 06/05/2015.

Study design

Multicenter randomized superiority trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Choledocholithiasis and other conditions requiring endoscopic retrograde cholangiopancreatography (ERCP)

Intervention

High volume intravenous hydration with lactated Ringer's solution

Added 17/02/2017:
Partcipants are randomised to one of two treatment arms:
1. Control group: 100mg rectal NSAID + no or mild hydration with normal saline (max 1.5mL/kg/hr, max. 3L/24h)
2. Intervention group: 100mg rectal NSAID + hydration with lactated Ringer’s solution (20mL/kg <60min, starting at the beginning of ERCP (scope-mouth contact), followed by 3mL/kg/hr for 8 hours)

Patients are discharged after ERCP after a minimal clinical stay of 24 hours. It is at the discretion of the treating physician whether an admission or longer monitoring is indicated. All patients are followed up for 180 days after randomization.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Post-ERCP pancreatitis, according to Cotton criteria

Secondary outcome measures

1. Severity of post-ERCP pancreatitis measured at discharge (Cotton criteria)
2. Severe morbidity (Atlanta criteria) or death measured at discharge
3. ERCP related complications within 48 hours after ERCP
4. Fluid hydration related complications within 24 hours after ERCP or at the latest at discharge
5. Length of hospital stay (including stay on the intensive care unit) measured after a follow up period of 6 months (so readmissions can be taken into account)
6. Direct and indirect costs measured after 6 months of follow up
7. Risk factors for developing post-ERCP pancreatitis measured at baseline
8. Generic health-related quality of life measured with EQ5D and SF36
9. Exocrine and endocrine pancreatic insufficiency at 180 days: fecal elastase-1 and HbA1c
10. Incidence of delayed post-ERCP pancreatitis

Overall trial start date

01/04/2015

Overall trial end date

01/07/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Requiring ERCP
2. Between 18 and 85 years of age
3. Signed informed consent

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

826 patients

Participant exclusion criteria

1. Allergy to NSAIDs or other contraindications
2. Ongoing acute pancreatitis
3. Ongoing hypotension, including those with sepsis
4. Cardiac insufficiency (CI, >NYHA Class I heart failure)
5. Renal insufficiency (RI, creatinin clearance <40ml/min)
6. Active ulcer disease
7. Severe liver dysfunction: liver cirrhosis and ascites
8. Respiratory insufficiency (pO2<60mmHg or 90% despite FiO2 of 30% or requiring mechanical ventilation)
9. Pregnancy
10. Hyponatremia (Na+ levels < 130mmol/l)
11. Hypernatremia (Na+ levels > 150mmol/l)
12. Oedema
13. Low risk of PEP: chronic calcific pancreatitis (PD intervention is allowed) or pancreatic head mass or routine biliary stent exchange or re-ERCP with a history of endoscopicsphincterotomy with a CBD intervention (PD intervention is allowed)

Recruitment start date

05/06/2015

Recruitment end date

01/01/2019

Locations

Countries of recruitment

Netherlands

Trial participating centre

Radboud University Medical Center
Nijmegen
-
Netherlands

Trial participating centre

St. Antonius Hospital
Nieuwegein
-
Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
-
Netherlands

Trial participating centre

Jeroen Bosch Hospital
's Hertogenbosch
-
Netherlands

Trial participating centre

Onze Lieve Vrouwe Gasthuis
Amsterdam
-
Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
-
Netherlands

Trial participating centre

Isala Clinics
Zwolle
-
Netherlands

Trial participating centre

Kennemer Gasthuis Hospital
Haarlem
-
Netherlands

Trial participating centre

Medisch Spectrum Twente Hospital
Enschede
-
Netherlands

Trial participating centre

Univeristy Medical Center Utrecht
Utrecht
-
Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
-
Netherlands

Sponsor information

Organisation

Radboud University Medical Center

Sponsor details

Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
(024) 361 47 60
erwin.vangeneen@radboudumc.nl

Sponsor type

Hospital/treatment centre

Website

www.radboudumc.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Radboud University Medical Center, Department of Gastroenterology and Hepatology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Organisation for Health Research and Development

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

A manuscript with the study results will be sent to a peer-reviewed journal for publication in Q4/2019-Q1/2020, regardless of the outcome. Around the same date, an abstract will be sent to international congresses such as the DDW and UEGW.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Erwin van Geenen (Erwin.vangeenen@radboudumc.nl).

Intention to publish date

01/01/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/02/2017: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/11/2016 to 01/01/2019. 2. The overall trial end date was changed from 01/01/2017 to 01/07/2019.