Condition category
Digestive System
Date applied
04/03/2015
Date assigned
18/05/2015
Last edited
09/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Every year 17,000 endoscopic retrograde cholangiopancreatographies (ERCP, a procedure to evaluate and treat conditions concerning the bile duct) are performed in the Netherlands. 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 evaluated in an initial study which compared standard intravenous (IV) fluid administration with an aggressive rehydration protocol with Ringer’s lactate (RL, a type of infusion fluid). But the limitations of the study were the small number of patients involved and the fact that none of them received anti-inflammatory drugs. The current study investigates the value of peri-ERCP hydration with RL on top of standard care, including anti-inflammatory drugs.

Who can participate?
Patients undergoing ERCP with a moderate-severe risk for developing PEP.

What does the study involve?
We will compare intensive RL hydration in addition to rectal anti-inflammatory drugs, which is the standard of care. Participants will have the following tests: post-procedural blood sampling, body measurements and a questionnaire (15-30 min) 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?
From 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 below 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

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: will become apparent within 48 hours after ERCP
4. Fluid hydration related complications: will become apparent 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 will also be measured after 6 months of follow up
7. Risk factors for developing post-ERCP pancreatitis will be 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

01/01/2017

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 NSAID's 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

01/11/2016

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 2017.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes