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Idiomas disponibles
Idiomas disponibles
GERD
Hypoglycemia
Hyperglycemia
Concurrent illness
Diarrhea
Constipation
Serum chemistry changes
Vitamin and mineral deficiency
GI liner migration/rotation
Nausea/vomiting
Weakness
EndoBarrier Gastrointestinal Liner
Delivery
How supplied
The EndoBarrier Gastrointestinal liner with delivery system
is packaged sterile. The product is sterilized with ethylene
oxide.
Equipment Requirements
1. Fluoroscopy unit
2. Video GI endoscopy system, gastroscope with a 2.8 mm
working channel and OD of 8.6 – 9.8 mm.
3. Gastrografin, Renografin, or equivalent water soluble
contrast media for fluoroscopy, 60 cc. Do not use
barium.
4. 60 cc syringes, 20 cc syringes
5. Sterile saline, 200 cc
6. .035 inch super stiff nitinol guidewire
7. EndoBarrier Gastrointestinal Liner with Delivery System
(Supplied by GI Dynamics)
8. EndoBarrier Gastrointestinal Liner Retrieval System
(Supplied by GI Dynamics)
9. An esophageal overtube 50 cm in length that will fit an
8.6-10 mm endoscope
Patient preparation
1. Patients must eat nothing per mouth for eight (8) hours
prior to the procedure.
2. Patients must be started on a proton pump inhibitor
(40 mg omeprozole twice a day or equivalent) three (3)
days before the procedure and should continue the
medication until two (2) weeks after the GI liner is
removed.
3. Antispasmodics may be used.
4. A 2-gram dose of ceftriaxone (or equivalent) should be
administered intravenously 1-2 hours prior to GI liner
placement.
Sedation
The physician should determine if general anesthesia or
conscious sedation is appropriate for the patient.
Procedural Steps
1. Lay the patient on the left side.
2. Advance the gastroscope into the duodenum and perform
a surveillance exam.
3. Advance the super-stiff guidewire into the duodenum
through the gastroscope working channel. Advance and
loop the tip of the wire in the duodenum.
4. Remove the gastroscope over the wire while maintaining
the wire position. Use fluoroscopy to ensure the loop of
wire remains fixed in the duodenum. Minimize the
length of wire through the stomach.
5. While maintaining guidewire position, advance the
capsule of the catheter over the guidewire and into the
duodenum. If needed, pull back slightly on the
guidewire to lift the capsule into the pylorus. The
gastroscope may be used to help place the capsule into
the pylorus.
6. Remove the guidewire. If the guidewire is not easily
removed, pull the capsule out of the pylorus into the
stomach and try again. If significant resistance is still
met, remove the gastroscope and then remove the entire
catheter system and start over.
7. Slowly advance the inner catheter, by pressing the button
on the handle (#1) and sliding the handle piece forward.
Release the button to slide the handle piece back and
repeat. Advance the inner catheter while observing with
fluoroscopy until the catheter is fully delivered as
indicated by the distal most reference marker on the
inner shaft. If resistance is met, apply forward pressure
and wait for peristalsis to advance the catheter.
Notes:
Advance the inner catheter slowly. The catheter
may prolapse if advanced too quickly.
The GI liner is fully delivered when the proximal
radiopaque marker advances approximately
2-3 cm distal to the capsule.
8. Retract the inner catheter locking wire (#2) 10 cm to
release the distal ball and the liner.
9. Advance the stiffening wire (#3) to push the ball off the
distal end of the catheter. Use fluoroscopy to confirm
that the ball is released. Once the ball is off, pull the
stiffening wire back (#3) to its stop position.
10. Reintroduce the gastroscope into the stomach. Ensure
that the delivery capsule is fully in the bulb.
Precaution: If the capsule does not fit entirely within
the bulbous duodenum, remove the gastroscope then
the entire system. This is an indication that the GI liner
may not fit well and should not be placed.
11. Retract the anchor locking wire (#4) 10 cm to unlock
the anchor.
12. Under endoscopic visualization, position the capsule so
that the solid black capsule marker is aligned with the
proximal side of the pylorus. Advance the anchor
plunger (#5) to deploy the anchor partially out of the
capsule, with the barbs remaining in the capsule. Verify
the position of capsule, then deploy the anchor by
pushing the anchor deployment handle (#5).
Note: Once the anchor is deployed, continue removing
the capsule from the bulb through the pylorus while
holding the inner catheter steady, until the capsule is in
the stomach.
Warning: Do not permit the capsule to advance into the
esophagus. Maintain the capsule in the stomach distal to
the gastroscope at all times until the gastroscope is
removed.
13. Remove the stiffening wire (#3) from the inner catheter.
14. Inject roughly 60 cc of saline or 20% Gastrografin
solution through the stiffening wire port of the inner
catheter to fill the GI liner with fluid. Then inject
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