Transluminal drainage of PAncreatic fluid collections using a self-expandable metallic sTENT

Patients with an acute or chronic pancreatitis which is complicated by a
pancreatic fluid collection is preferably treated by endoscopic drainage with
transluminal stents. Endoscopic drainage is performed by placement of at least
1 or more transluminal double pigtail stents. Drainage by this type of stents
is succesful in 85% of cases. Despite occlusion the efficacy is determined by
the fistula created by the stents. A larger diameter of the fistula would cause
a faster and more effective drainage as is known for the surgical
cystenterostomy. Using self-expandable metallic stents to create a large
transluminal fistula is described in only a few studies. To determine whether
the use of a large diameter SEMS can earn a place in the tranluminal treatment
of PFCs we will perform a prospective trial with the aim to evaluate the safety
and efficacy of the diabolo shaped Niti-S SE covered stent in the endoscopic
treatment of PFCs.

To perform a pilot study to evaluate safety and efficacy of using a covered
self-expandable metallic stent for transluminal endoscopic drainage of a
pancreatic fluid collection.

We will conduct a propective cohort pilot study in which 20 patients with a
symptomatic pancreatic fluid collection in the setting of acute or chronic
pancreatitis will be included. Patients will undergo a transluminal endoscopic
drainage of the pancreatic fluid collection with placement of a covered
self-expandable metallic stent.

Patients will be treated under conscious sedation or with Propofol. Prior to
the procedure prophylactic (broad spectrum) antibiotics will be administered. A
linear echoendoscope will be introduced after which the PFC will be visualised.
Color Doppler ultrasound can be used to identify regional vasculature. Using a
19 G needle the PFC will be punctured from the stomach or the duodenum. After
puncturing, a fluid sample will be collected and send for analysis (amylase,
CEA). A 0.035-inch guidewire will be introduced through the needle and coiled
into the cyst under fluoroscopic and EUS guidance. After removal of the needle
a 10 Fr cystotome will be introduced in order to enlarge the fistula.
Additionally, balloon dilation of the fistula using a 6 mm or 8 mm balloon will
be performed. The balloon will be exchanged for a silicone covered
self-expandable nitinol stent, 16 mm in diameter, 20 mm length (Niti S SEMS,
Taewoong Medical). Patients will be admitted to the hospital for one night.

Risks of participation could be stent migration into the cyst which can mean
additional interventions. In case of complications the gastroenterologist will
decide to re-intervene endoscopically and if necessary decide to remove the
stents prematurely. The burden of participating patients will be 1 office
visit.