Single-dose Linaclotide for Capsule Endoscopy Preparation
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/15/2016 |
| Start Date: | February 2015 |
| End Date: | June 2016 |
Video capsule endoscopy is an important procedure that can be used by doctors to find
abnormalities in the small intestine, especially those that can cause bleeding. The
procedure uses a tiny wireless camera to take pictures of the digestive tract. The camera
sits inside a vitamin-sized capsule that a person can swallow. As the capsule travels
through the digestive tract, the camera takes thousands of pictures that are transmitted to
a recorder worn on a belt around a person's waist or over his/her shoulder. However,
abnormalities can be missed partly because the normal dark liquids present in the intestine
can prevent abnormalities from being recorded, hiding them from the physician who reviews
the video.
The current method used to clear these dark liquids from your small intestine is to follow a
clear liquid diet and drink approximately 2 quarts of polyethylene glycol (Golytely®) the
day before the video endoscopy and take simethicone (a medication used to treat symptoms of
gas such as uncomfortable or painful pressure, fullness, and bloating) the morning of the
test.
Some of the current preparations to clear these dark liquids are not able to entirely
prevent abnormalities from being missed and most have an unpleasant taste or involve
drinking a lot of fluid.
Linaclotide (Linzess®) is a medication approved by the Food and Drug Administration (FDA)
for the treatment of constipation and irritable bowel syndrome. It is not approved by the
FDA for use as an aid for clearing dark liquid from the small intestine prior to a video
endoscopy.
A recent presentation at a medical meeting proposed using one-dose of linaclotide (Linzess®)
to improve cleansing of the small intestine for capsule endoscopy preparation to supplement
fasting and clear liquid diet.
This report claimed a noticeably better quality of small intestine cleansing and a 20%
shorter transit time for the capsule by taking one dose of linaclotide one hour before
patients swallowed the video capsule.
The purpose of this study is to assess the use of one dose of linaclotide in terms of the
total time it takes the capsule to move through the small bowel, and image quality as
compared to the current method. The results of this study will be compared to previous
patients who drank the preparation that is currently used
abnormalities in the small intestine, especially those that can cause bleeding. The
procedure uses a tiny wireless camera to take pictures of the digestive tract. The camera
sits inside a vitamin-sized capsule that a person can swallow. As the capsule travels
through the digestive tract, the camera takes thousands of pictures that are transmitted to
a recorder worn on a belt around a person's waist or over his/her shoulder. However,
abnormalities can be missed partly because the normal dark liquids present in the intestine
can prevent abnormalities from being recorded, hiding them from the physician who reviews
the video.
The current method used to clear these dark liquids from your small intestine is to follow a
clear liquid diet and drink approximately 2 quarts of polyethylene glycol (Golytely®) the
day before the video endoscopy and take simethicone (a medication used to treat symptoms of
gas such as uncomfortable or painful pressure, fullness, and bloating) the morning of the
test.
Some of the current preparations to clear these dark liquids are not able to entirely
prevent abnormalities from being missed and most have an unpleasant taste or involve
drinking a lot of fluid.
Linaclotide (Linzess®) is a medication approved by the Food and Drug Administration (FDA)
for the treatment of constipation and irritable bowel syndrome. It is not approved by the
FDA for use as an aid for clearing dark liquid from the small intestine prior to a video
endoscopy.
A recent presentation at a medical meeting proposed using one-dose of linaclotide (Linzess®)
to improve cleansing of the small intestine for capsule endoscopy preparation to supplement
fasting and clear liquid diet.
This report claimed a noticeably better quality of small intestine cleansing and a 20%
shorter transit time for the capsule by taking one dose of linaclotide one hour before
patients swallowed the video capsule.
The purpose of this study is to assess the use of one dose of linaclotide in terms of the
total time it takes the capsule to move through the small bowel, and image quality as
compared to the current method. The results of this study will be compared to previous
patients who drank the preparation that is currently used
Video capsule endoscopy is an important modality for detection of lesions in the small
intestine. It is particularly helpful in patients with occult sources of gastrointestinal
bleeding, suspected Crohn's disease, ulcerative jejunitis, and in cases where a small
intestinal neoplasm is suspected. Despite advances in technique and equipment, significant
limitations remain in obtaining adequate visualization due to dark bilious fluid that
obscures the mucosa. Furthermore, limitations of battery technology mean that in
approximately 16.5% of studies the capsule will fail to visualize the entire small bowel.
Numerous methods of bowel preparation have been used for capsule endoscopy. To date, all of
them are unpleasant/have significant side effects. This is particularly onerous given that
the majority has already had a similar but more extensive preparation for colonoscopy.
Furthermore, overall efficacy is varied, and the preparation frequently remains suboptimal.
The University of Virginia Health System Motility Lab uses a current regimen of 2000 mL of
golytely and simethicone, but incomplete and partially occluded portions of the small bowel
remain persistent clinical issues. Nearly one in five studies may ultimately have to be
repeated as a result.
A recent presentation by Ira J. Schmelkin, M.D. proposed the use of single-dose linaclotide
for capsule endoscopy preparation to supplement fasting and clear liquid diet. In an
uncontrolled series, he noted a clinically significant improvement in preparation quality
and a 20% shorter transit time (compared with published norms) with one higher range dose of
linaclotide an hour prior to endoscopy. Linaclotide is guanylate cyclase-C that acts on the
luminal surface of the intestinal epithelium thereby stimulating secretion of chloride and
bicarbonate into the intestinal lumen, resulting in increased intestinal fluid and increased
motility. The increased motility and secretion throughout the gastrointestinal tract make it
a potentially useful agent to decrease capsule transit time and decrease the amount of dark
small intestine fluid, thereby improving capsule endoscopy yield. Initial reports suggest
that linoclotide is generally well tolerated, with the primary side effect of diarrhea. The
investigators propose to study the use of a single dose for capsule endoscopy preparation.
The hypothesis is that single-dose linaclotide will lead to significantly decreased transit
time and improved small bowel visualization quality when compared to controls using
polyethylene glycol and simethicone (standard of care).
The investigators propose to prospectively enroll approximately 30 patients as subjects, who
will receive a single dose of 290mcg one hour prior to capsule endoscopy. This was
calculated using power calculations from values of the Viazis study, who noted an average
transit time of approximately 290 minutes, compared with approximately 190 minutes in the
data from Schmelkin. Given the standard deviation of approximately 90 minutes in Viazis,
power calculation with an alpha of 0.05 and a beta of 0.80 would require 18 subjects per
group. The investigators will target 30 to allow for dropouts and to allow the use of
statistics pertaining to large (approximately 30 and up) numbers of subjects.
All adult patients undergoing capsule endoscopy (with the exception of certain criteria,
such as severe gastroparesis, pregnancy, non-English speaking, prisoners, those unable to
give consent, prior small intestinal resection) will be approached sequentially until
completion of the study. These will be matched 1:1 with historic controls selected at random
from cases in the prior three years. The same exclusion criteria will be applied to both
groups. There will be two primary outcomes: total transit time and rated overall mucosal
visualization (categorized as ideal, good, inadequate or poor/needs repetition). Primary
analysis will presume no confounding and use a t-test and chi-square, respectively. Should
the groups prove significantly different, the investigators also plan to use adjusted
analysis. The investigators will plan to collect BMI, history of reflux, age, sex,
gastroparesis, diabetes, narcotic use, other conditions e.g. Parkinson's, lupus, scleroderma
as these may affect transit time for the historic controls.
Two gastrointestinal fellows or attending level gastroenterologists will perform the scoring
of the images recorded during the capsule endoscopy in a blinded manner. Secondarily, the
investigators will also look at the percentage of capsule endoscopies detecting a culprit
lesion, and the percentage of failed (incomplete) studies.
intestine. It is particularly helpful in patients with occult sources of gastrointestinal
bleeding, suspected Crohn's disease, ulcerative jejunitis, and in cases where a small
intestinal neoplasm is suspected. Despite advances in technique and equipment, significant
limitations remain in obtaining adequate visualization due to dark bilious fluid that
obscures the mucosa. Furthermore, limitations of battery technology mean that in
approximately 16.5% of studies the capsule will fail to visualize the entire small bowel.
Numerous methods of bowel preparation have been used for capsule endoscopy. To date, all of
them are unpleasant/have significant side effects. This is particularly onerous given that
the majority has already had a similar but more extensive preparation for colonoscopy.
Furthermore, overall efficacy is varied, and the preparation frequently remains suboptimal.
The University of Virginia Health System Motility Lab uses a current regimen of 2000 mL of
golytely and simethicone, but incomplete and partially occluded portions of the small bowel
remain persistent clinical issues. Nearly one in five studies may ultimately have to be
repeated as a result.
A recent presentation by Ira J. Schmelkin, M.D. proposed the use of single-dose linaclotide
for capsule endoscopy preparation to supplement fasting and clear liquid diet. In an
uncontrolled series, he noted a clinically significant improvement in preparation quality
and a 20% shorter transit time (compared with published norms) with one higher range dose of
linaclotide an hour prior to endoscopy. Linaclotide is guanylate cyclase-C that acts on the
luminal surface of the intestinal epithelium thereby stimulating secretion of chloride and
bicarbonate into the intestinal lumen, resulting in increased intestinal fluid and increased
motility. The increased motility and secretion throughout the gastrointestinal tract make it
a potentially useful agent to decrease capsule transit time and decrease the amount of dark
small intestine fluid, thereby improving capsule endoscopy yield. Initial reports suggest
that linoclotide is generally well tolerated, with the primary side effect of diarrhea. The
investigators propose to study the use of a single dose for capsule endoscopy preparation.
The hypothesis is that single-dose linaclotide will lead to significantly decreased transit
time and improved small bowel visualization quality when compared to controls using
polyethylene glycol and simethicone (standard of care).
The investigators propose to prospectively enroll approximately 30 patients as subjects, who
will receive a single dose of 290mcg one hour prior to capsule endoscopy. This was
calculated using power calculations from values of the Viazis study, who noted an average
transit time of approximately 290 minutes, compared with approximately 190 minutes in the
data from Schmelkin. Given the standard deviation of approximately 90 minutes in Viazis,
power calculation with an alpha of 0.05 and a beta of 0.80 would require 18 subjects per
group. The investigators will target 30 to allow for dropouts and to allow the use of
statistics pertaining to large (approximately 30 and up) numbers of subjects.
All adult patients undergoing capsule endoscopy (with the exception of certain criteria,
such as severe gastroparesis, pregnancy, non-English speaking, prisoners, those unable to
give consent, prior small intestinal resection) will be approached sequentially until
completion of the study. These will be matched 1:1 with historic controls selected at random
from cases in the prior three years. The same exclusion criteria will be applied to both
groups. There will be two primary outcomes: total transit time and rated overall mucosal
visualization (categorized as ideal, good, inadequate or poor/needs repetition). Primary
analysis will presume no confounding and use a t-test and chi-square, respectively. Should
the groups prove significantly different, the investigators also plan to use adjusted
analysis. The investigators will plan to collect BMI, history of reflux, age, sex,
gastroparesis, diabetes, narcotic use, other conditions e.g. Parkinson's, lupus, scleroderma
as these may affect transit time for the historic controls.
Two gastrointestinal fellows or attending level gastroenterologists will perform the scoring
of the images recorded during the capsule endoscopy in a blinded manner. Secondarily, the
investigators will also look at the percentage of capsule endoscopies detecting a culprit
lesion, and the percentage of failed (incomplete) studies.
Inclusion Criteria:
- Schedule for video endoscopy at UVHS
- Ability to speak, read and write English
- Age >18
- Able to provide consent
Exclusion Criteria:
- Prisoner
- Woman who is currently pregnant or breastfeeding
- Allergy to linaclotide
- Patients with known or suspected mechanical gastrointestinal obstruction
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