To evaluate the hypothesis that patients with an abnormal pancreatic duct (PD) in which the transluminal stents are left in situ have a lower pancreatic fluid collection recurrence rate after endoscopic transluminal drainage in comparison to…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrence of a PFC (>6 cm or symptomatic) proximal to the initial PD
disruption after endoscopic drainage at or within 18 months after initial
drainage
Secondary outcome
* Complications such as infection, pain that could be associated to leaving
stents in situ
* Number of spontaneous stent migrations before removal
Background summary
An acute pancreatitis can be complicated by a pseudocyst which can be treated
by transluminal endoscopic drainage with stent placement. In case of pancreatic
duct disruption, it may be favorable, as for recurrence of the fluid
collection, to leave the transluminal stents in situ at least during the first
year following endoscopic drainage.
Study objective
To evaluate the hypothesis that patients with an abnormal pancreatic duct (PD)
in which the transluminal stents are left in situ have a lower pancreatic fluid
collection recurrence rate after endoscopic transluminal drainage in comparison
to patients in which the transluminal stents are retrieved.
Study design
Randomized controlled multi-center trial
Study burden and risks
For this study we will evaluate the hypothesis that patients with an abnormal
pancreatic duct in which the transluminal stents are left in situ have a lower
pancreatic fluid collection recurrence rate after endoscopic transluminal
drainage in comparison to patients in which the transluminal stents are
retrieved. Benefits of leaving the stents in situ for a longer period of time
could be a lower recurrence rate of a pancreatic fluid collection. Associated
risks could be infection and pain that can be associated with leaving the
stents in situ. Additionally, the stents can migrate spontaneously. In case of
complications the gastroenterologist will decide to reintervene endoscopically
and if necessary decide to remove the stents prematurely.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Patient over 18 years old
* PFC resolution (no remaining fluid collection larger than 3 cm)
* Pigtail(s) positioned in remnant PFC
* Abnormal PD on S-MRCP performed 12-16 weeks after drainage
- ductal dilation (* 5 mm in body or tail)
- ductal disruption
- both ductal dilation and ductal disruption
Exclusion criteria
* PFC complicating chronic pancreatitis
* PFC after surgery
* Recurrence of prior treated PFC
* Acute-on-chronic pancreatitis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35810.018.12 |