To determine the safety and feasibility of EUS-guided gallbladder drainage with the AXIOS stent in patients with acute cholecystitis unsuitable or at high risk for surgery.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Short term major complications, defined as any stent-related life threatening
and/or severe event during stent placement or within week (7 days), e.g. bile
leakage with development of bile peritonitis, significant bleeding, unscheduled
endoscopic/surgical intervention due to adverse event.
- Long term major complications, defined as any stent-related life threatening
and/or severe event during occurring later than 1 week (7 days) from stent
placement.
- Recurrence of cholecystitis; defined as recurrence of acute cholecystitis
according to Tokyo Guidelines after complete clinical response, either before
or after stent removal.
Secondary outcome
- Technical success of stent placement; defined as transmural passage of the
stent across the stomach or duodenum into the gallbladder.
- Functional success of stent placement; defined as normalization of clinical
parameters of acute cholecystitis within 96 hours. Clinical parameters reported
are abdominal pain evaluated by the patients on a 10-point visual analogue
scale, temperature, white blood cell count and serum C-reactive protein
concentration.
- Total procedure time; time between first entry of and last withdrawal from
the mouth.
- Technical success of stent removal; defined as removal of the stent in a
single session without complications.
- Stent patency at stent removal; defined as a patent stent opening assessed
during upper endoscopy.
- Stent migration at stent removal: defined as any migration of the AXIOS stent
into the gallbladder (distal migration) or the stomach or duodenum (proximal
migration).
- Gallbladder characteristics including the presence of gallstones at 12 months
after initial stent placement.
Background summary
In elderly patients or patients with significant comorbidity, urgent
cholecystectomy in case of acute cholecystitis carries a high risk of morbidity
and mortality. To date, percutaneous gallbladder drainage is the treatment of
choice in these high risk patients. Recently, the technique of EUS-guided
transmural drainage has been described for drainage of the gallbladder with a
novel self-expandable metal stent (AXIOS stent), specially designed for
transmural drainage. Technical and functional results of this new technique
have been found to be promising, without serious complications.
Study objective
To determine the safety and feasibility of EUS-guided gallbladder drainage with
the AXIOS stent in patients with acute cholecystitis unsuitable or at high risk
for surgery.
Study design
This is a multi-center prospective non-randomised open label feasibility study
in 30 patients.
Intervention
EUS-guided transgastric or transduodenal gallbladder drainage with placement of
an AXIOS stent (Xlumena Inc., Mountain View, California USA). No comparator is
used.
Study burden and risks
The benefit of EUS-guided gallbladder drainage includes less patient discomfort
associated with an external drain, required for percutaneous gallbladder
drainage. Besides, complications due to inadvertent tube removal will be
reduced.
The burden of study participation for the patient consists of undergoing
EUS-guided gallbladder drainage instead of percutaneous gallbladder drainage.
Before the procedure and the first 96 hours after the procedure, the patient
will be asked to score the intensity of their abdominal pain. Measurement of
temperature and taking blood samples to determine white blood cell count and
serum C-reactive protein concentration will be conducted as part of standard
care. After three months endoscopy will be performed and the stent will be
removed if there are no stones present. If there are stones present, an
additional endoscopy will be performed after one month. Patients will be
contacted by phone up to six times in a period of a year to obtain information
about signs and symptoms of recurrence of acute cholecystitis and other
possible complications taking approximately 5-10 minutes for each phone call.
One year after the initial stent placement transabdominal ultrasound will be
performed.
The risk associated with participation is development of pneumoperitoneum
(9.0%), bile leakage (2.9%) and stent migration (1.5%). The complication rate
might be slightly higher with this new technique. However, the most prevalent
complication, pneumoperitoneum, can be considered as a minor complication which
can be managed conservatively in most patients.
Herenweg 57
3513CC Utrecht
NL
Herenweg 57
3513CC Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Acute cholecystitis, defined according to Tokyo Guidelines:
A. Local signs of inflammation: (1) Murphy*s sign, (2) RUQ mass/pain/tenderness
B. Systemic signs of inflammation: (1) Fever, (2) elevated CRP, (3) elevated WBC count
C. Imaging findings: imaging findings characteristic of acute cholecystitis
Definite diagnosis: (1) One item in A and one item in B are positive
(2) C confirms the diagnosis when acute cholecystitis is suspected
clinically
- Unsuitable for surgery, due to one (or more) of the following items:
A. ASA score > II (ASA = American Society of Anesthesiology)
B. APACHE II score >= 12 (APACHE = Acute Physiology and Chronic Health Evaluation)
C. Onset of symptoms >=7 days before first presentation in hospital
D. Advanced malignancy
E. Unsuitable for surgery upon expert*s opinion for any other reason
- >=18 years
- Eligible for endoscopic intervention
- Written informed consent
Exclusion criteria
- Pregnancy
- Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
- Patients unwilling to undergo follow-up assessments
- Patients diagnosed with pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus,
stomach and duodenum
- Patients with liver cirrhosis, portal hypertension and/or gastric varices
- Abnormal coagulation: INR > 1.5 and not correctable and/or platelets < 50.000/mm3
- Previous drainage of the galbladder
Design
Recruitment
Medical products/devices used
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 | NL39924.041.12 |