Fluid hydration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis: the FLUYT-prevent trial. a multicenter randomized controlled superiority trial.;Pancreatic duct stent placement to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients with unintended PD-wire cannulation: a multicenter prospective cohort

FLUYT:
Yearly 17.000 endoscopic retrograde cholangiopancreatographies (ERCP) are
performed in the Netherlands. The most prevalent complication is post-ERCP
pancreatitis (PEP) with an incidence between 3% and 16%. PEP leads to prolonged
hospitalization with substantial economic impact. Rectal NSAID*s (RN) carry the
most solid evidence in decreasing the PEP rate and is the current standard of
care according to the European Society of Gastrointestinal Endoscopy guideline.
Still a PEP incidence of around 8% is seen. A new strategy to prevent PEP was
performed by a pilot, randomized study comparing standard intravenous (IV)
fluid administration with an aggressive rehydration protocol with Ringer*s
lactate (RL). A positive effect on the incidence of PEP was seen in the RL
group (17% standard vs 0% RL, p=0.016). Major limitations of this monocenter
study are the limited amount of subjects included and that none of these
subjects received RN. The current study investigates the value of peri-ERCP
hydration with RL on top of standard care (RN) in preventing PEP and the
cost-effectiveness of this intervention.

FLUYT-2-PDS
PD-wire cannulation will occur more and more in the future because of the
preferred guide-wire assisted cannulation and the superiority of double wire
assisted cannulation compared to PD stent assisted cannulation. We think that
the efficacy of PDS in PEP prevention can potentially be increased, by limiting
the use of PDS to cases with unintentional PD cannulation during the ERCP
procedure, because of:
1. Less PDS failure rates (once you are in the PD, stent placement is usually
easy).
2. PD-wire cannulation is considered as one of the most dominant procedure
related PEP risk factor, which increases the PEP incidence. The cases will
probably benefit the most of and additional PD stent.

FLUYT: To investigate whether aggressive rehydration with RL during ERCP
prevents PEP and will be cost-effective.

FLUYT-2-PDS: To investigate if PDS placement further reduce the risk of the
development of PEP in patients with unintended PD-wire cannulation already
using prophylactic RN and thereby minimize costs related to complications of
ERCP.

FLUYT: A multicenter, randomized controlled trial.

FLUYT-2-PDS: A multicenter prospective cohort

FLUYT: Patients in the intervention group will receive 20cc/kg Ringer's lactate
within 60 minutes at the start of ERCP (scope-mouth contact), followed by
3cc/kg/hour during 8 hours post ERCP AND rectal NSAID
Patients in the control group will receive the standard amount of fluid with a
rectal NSAID.

FLUYT-2-PDS: not applicable

FLUYT: The patients burden is pre and post procedural blood urine sampling,
body measurements and a questionnaire (15min) 30 days after the procedure.
During follow-up, a stool sample will be asked from patients who developed
post-ERCP pancreatitis, as well as a blood sample for HbA1c measurement.
Possible risks are associated with hyperhydration (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.

FLUYT-2-PDS: The patients burden is pre and post procedural blood urine
sampling and body measurements. During follow-up, a stool sample will be asked
from patients who developed post-ERCP pancreatitis, as well as a blood sample
for HbA1c measurement.