Please click on the question to be directed to its answer
Q:
We have always had the patient wear the sensors/DataRecorder for 8 hours. A co-worker recently heard it was okay to discontinue the test after 6hrs. Is this okay or should we get the full 8 hours?
Q:
Why do patients withhold Calcium Channel Blockers on the day of Capsule Endoscopy?
Q:
Must patients with "retained" capsules avoid exposure from MRI machines?
Q:
A female patient where the PillCam SB has been retained for almost 3 months now wishes to become pregnant. What is the recommendation regarding the retained PillCam SB?
Q:
Should a patient quit smoking before and during capsule endoscopy? If so, why?
Q:
In a recent study, the tracking or PillCam locator that is usually part of the study was not present. I have not encountered this problem before. Is this a recording problem? Is it related to that one capsule? Please advise so we can prevent this from occurring again.
Q:
I have had my ileostomy for over 25 years. What are the indications and/or contraindications for capsule endoscopy in a patient with a history of Crohn's disease and an ostomy?
Q:
Is gastric bypass a contraindication for capsule endoscopy. If not would small bowel follow through be advised prior to the capsule?
Q:
A patient has had a capsule retained in the Ileum for over 2 months. The patient has refused surgical removal. How long can the capsule safely remain within the body? When should more aggressive recovery methods be employed?
Q:
We have an interest in using capsule endoscopy for urologic applications in animal models. Can this device be sutured into place and still provide images? Can they be reused if harvested from the animal model at the end of the experiment?
Q:
I found a small bowel tumor on one of my studies that turned out to be a spindle cell tumor. Do you know if these have been described previously with capsule endoscopy?
Q:
How long can a capsule remain in vivo? A study was done on a 36 year old male with known Crohn's disease to evaluate the extent of his disease. A small bowel x-ray was done prior to evaluate for strictures and the radiologist and gastroenterologist felt that the capsule would pass. The capsule appears to be in the terminal ileum and can be manipulated via fluoroscopy. We have unsuccessfully administered magnesium citrate in an attempt to induce passage. The patient remains asymptomatic, is having bowel movements, and is on prednisone and Infliximab therapy.
Q:
Has the PillCam been found helpful in cases of gatroparesis or motility problems where the stomach will not empty?
Q:
Are we required to keep a copy of the actual CE study by saving it to some storage medium, e.g. a CD-ROM, DVD, hard drive, etc.? What is the common practice? What is the legal implication of keeping a copy in the event of litigation?
Q:
I know that presence of a pacemaker or AICD is considered an absolute contraindication for capsule endoscopy. What specific problem could this cause? Is it related to possible damage to the pacemaker or to the capsule and DataRecorder?
Q:
In a recent study on a cirrhotic patient, we observed gastric antral vascular ectasia, multiple diffuse angiodysplasias in the small bowel, and a lesion in the jejunum very similar to the "spider naevi" that we observe in the skin of patients with liver disease. Is observation of such lesions described in the current literature?
Q:
What is the latest data regarding capsule retention? Specifically, what is its incidence, what is the length of time capsules can be safely retained, and what is the reported frequency of surgical removal?
Q:
Is the PillCam capable of capturing images of the esophagogastric junction? Can it be used to detect pathology in this area, such as GERD, Barrett's esophagus, etc.?
Q:
I have had a patient referred for Capsule Endoscopy that is currently taking NuLev as well as using a Duragesic Patch. Do you have optimal time guidelines for the discontinuation of narcotics and motility-slowing drugs prior to CE?
Q:
Are there known complications from large bowel capsule retention? I have been told that there are cases with capsule almost stationary in large bowel for months without complications or symptoms.
Q:
In a patient with gastric bypass, are there special recommendations or precautions?
Q:
Is there a limit on the size of a patient's abdomen? We have a patient with a 60" waist that weighs 430 pounds. Will there be any problems with image capture?
Q:
My hospital has a policy stating that a patient must first have either an EGD/Colonoscopy, or UGI/BE prior to capsule endoscopy. What is the recommendation of Given Imaging?
Q: We have always had the patient wear the sensors/DataRecorder for 8 hours. A co-worker recently heard it was okay to discontinue the test after 6hrs. Is this okay or should we get the full 8 hours?
A: As long as the DataRecorder LED is still blinking at the recording rate of 2 blinks per second, premature discontinuation of the procedure may sacrifice useful information that could be obtained if the equipment was still attached until at least 8 hours following ingestion.
A soon to be released device from Given Imaging will allow the user to determine in real time if the PillCam™ SB has reached the cecum. Called RAPID® Access, this will allow a doctor to electively stop a study if desired in less than 8 hours with confidence that the entire small bowel has been traversed by the capsule.
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Why do patients withhold Calcium Channel Blockers on the day of Capsule Endoscopy?
A: They can affect gastrointestinal motility and potentially influence the results of a CE study.
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Must patients with "retained" capsules avoid exposure from MRI machines?
A: An MRI can affect any metallic or metal containing object so patients (or anyone in proximity to an MRI scanner) are cautioned that they may not have any such device in or near an MRI. You may wish to consult with a radiologist for more information.
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A female patient where the PillCam SB has been retained for almost 3 months now wishes to become pregnant. What is the recommendation regarding the retained PillCam SB?
A: Based on published reports, a retained capsule in any patient bears potential for a pathologic lesion at the site of retention. Even if the patient is asymptomatic, the clinician may consider further investigations depending on the location of the retention. The doctor may be even more inclined to pursue this before the patient becomes pregnant.
There is no data on the safety of capsule endoscopy in pregnancy. Capsule ingestion is contraindicated in the pregnant patient, as CE has not been tested in such a situation.
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Should a patient quit smoking before and during capsule endoscopy? If so, why?
A: While there had been concern in the past that cigarette smoking may alter the appearance of the gastric mucosa, this is no longer felt to be significant. Thus, patients are not routinely instructed to stop smoking because of capsule endoscopy.
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In a recent study, the tracking or PillCam locator that is usually part of the study was not present. I have not encountered this problem before. Is this a recording problem? Is it related to that one capsule? Please advise so we can prevent this from occurring again.
A: You have described the localization feature. The fact that it was not present could indicate several things:
- If the capsule stayed in one part of the tract too long, the algorithm for localization would have prevented it from showing. It is dependant upon all 8 leads getting good signal strength. We see this in motility issues or in cases where there may have been blockages or reduced lumens.
- There could also be issues with the equipment itself. Please check to see that the Sensor Array has no bends, tears, or breaks and that it connects to the Data Recorder without issue.
- Lastly, it may be an issue that we can only diagnose through the video's diagnostic files.
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I have had my ileostomy for over 25 years. What are the indications and/or contraindications for capsule endoscopy in a patient with a history of Crohn's disease and an ostomy?
A: Currently, there have been over 250,000 ingestions of the PillCamTM SB capsule endoscope. In general, the reported incidence of retained capsules after PillCamTM SB capsule endoscopy (CE) requiring surgical intervention has been reported to be significantly less than one percent. However, patients who have had a history of intestinal surgery are believed to have an increased risk of capsule retention. CE has been reported to be performed successfully with normal excretion of the capsule in patients who have undergone surgery including creation of ileostomy. Unfortunately, there is limited data available to accurately predict whether a capsule will be retained in such patients.
Furthermore, based on published and unpublished data, the PillCamTM SB capsule has been reported to be retained in the gastrointestinal tract for periods of at least two years without any adverse event. The capsule has been shown to remain intact, without symptoms, in many cases, for many months.
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Is gastric bypass a contraindication for capsule endoscopy. If not would small bowel follow through be advised prior to the capsule?
A: Gastric bypass should not be a contraindication on its own. It can indicate a higher likelihood of delayed passage of the PillCamTM from the stomach. Consideration may be given to the administration of prokinetics, positioning, or even endoscopic placement through the pylorus if there is a concern for delayed gastric emptying. It is unclear whether radiography will assist in predicting whether there will be delayed passage of the capsule. Prior abdominal surgery may be associated with adhesions or other causes of bowel obstruction which may also delay capsule passage. This should be considered when evaluating the patient for CE.
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A patient has had a capsule retained in the Ileum for over 2 months. The patient has refused surgical removal. How long can the capsule safely remain within the body? When should more aggressive recovery methods be employed?
A: The PillCam SB capsule has been reported to be retained in the gastrointestinal tract for up to two years without symptoms. A large retrospective review by Chaifetz, et.al. found that a retained capsule often leads to a diagnosis. Furthermore, composed of biocompatible materials, its components are believed to be non-toxic.
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We have an interest in using capsule endoscopy for urologic applications in animal models. Can this device be sutured into place and still provide images? Can they be reused if harvested from the animal model at the end of the experiment?
A: The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up.
The PillCam™ Capsule is contraindicated for use under the following conditions:
- In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
- In patients with cardiac pacemakers or other implanted electro-medical devices.
- In patients with swallowing disorders.
The capsule is not intended for non-human use nor is it designed to be sutured in place or to be used in the urologic system. Also, it is not made to be reused, and the resulting video is not expected to be more than 10 hours.
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I found a small bowel tumor on one of my studies that turned out to be a spindle cell tumor. Do you know if these have been described previously with capsule endoscopy?
A: Numerous small intestinal tumors have been reported to be identified by PillCam capsule endoscopy including GISTs. You may find additional information and references on the website www.CapsuleEndoscopy.org.
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How long can a capsule remain in vivo? A study was done on a 36 year old male with known Crohn's disease to evaluate the extent of his disease. A small bowel x-ray was done prior to evaluate for strictures and the radiologist and gastroenterologist felt that the capsule would pass. The capsule appears to be in the terminal ileum and can be manipulated via fluoroscopy. We have unsuccessfully administered magnesium citrate in an attempt to induce passage. The patient remains asymptomatic, is having bowel movements, and is on prednisone and Infliximab therapy.
A: There have been reports of PillCamTM SB capsule being retained for months, even nearly two years without any symptoms or related complications. There have also been reports of a retained capsule being excreted naturally after the patient is treated for Crohn's disease in cases of stricture.
Studies demonstrate that small bowel radiology can miss strictures. Additionally, data indicates that retained capsules often identify useful pathologic findings that were not otherwise available to the treating physicians. It is important to closely review the CE study, particularly at the end of the video.
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Has the PillCam been found helpful in cases of gatroparesis or motility problems where the stomach will not empty?
A: PillCam SB is designed to evaluate the small bowel. It may be more difficult to utilize in a patient with gastroparesis or other motility disorders.
Back
Are we required to keep a copy of the actual CE study by saving it to some storage medium, e.g. a CD-ROM, DVD, hard drive, etc.? What is the common practice? What is the legal implication of keeping a copy in the event of litigation?
A: Given Imaging cannot make a recommendation in this regard. Please consult with your legal advisor as to an appropriate course of action for your practice.
Back
I know that presence of a pacemaker or AICD is considered an absolute contraindication for capsule endoscopy. What specific problem could this cause? Is it related to possible damage to the pacemaker or to the capsule and DataRecorder?
A: The presence of a pacemaker remains a contraindication to PillCam capsule endoscopy. This contraindication was put in place due to concern for possible interaction between the capsule and the pacemaker. However, recent studies have shown no interaction with any effect on the pacemaker or on the performance of the capsule endoscope.
Back
In a recent study on a cirrhotic patient, we observed gastric antral vascular ectasia, multiple diffuse angiodysplasias in the small bowel, and a lesion in the jejunum very similar to the "spider naevi" that we observe in the skin of patients with liver disease. Is observation of such lesions described in the current literature?
A: The lesions you have identified have been reported to be well visualized with PillCam SB. However, you may wish to submit your images to the on-line atlas at www.givenimaging.com., as well as at www.CapsuleEndoscopy.org.
Back
What is the latest data regarding capsule retention? Specifically, what is its incidence, what is the length of time capsules can be safely retained, and what is the reported frequency of surgical removal?
A: Based on published and unpublished data, the PillCam SB capsule has been reported to be retained in the GI tract for periods of at least 23 months without adverse event. The capsule has been shown to remain intact, without symptoms, for months. In fact, a large retrospective review by Chaifetz, et al. found that a retained capsule often leads to a diagnosis. Furthermore, the device is made of biocompatible material and its internal parts are believed to be non-toxic.
The incidence of capsule retention has been reported to be less than 1% but this figure may be higher in Crohn's disease or other conditions. The rate of surgical removal was noted to be 0.75%(Barkin JS, Friedman S. Am J Gastroentrol 2002; 97:A83).
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Is the PillCam capable of capturing images of the esophagogastric junction? Can it be used to detect pathology in this area, such as GERD, Barrett's esophagus, etc.?
A: The PillCamTM SB originally did capture images of the gastroesophageal junction. Since 2004, the PillCam ESO has been available as a device dedicated to this function. You may view examples of these at www.CapsuleEndoscopy.org.
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I have had a patient referred for Capsule Endoscopy that is currently taking NuLev as well as using a Duragesic Patch. Do you have optimal time guidelines for the discontinuation of narcotics and motility-slowing drugs prior to CE?
A: There is no data that recommends an appropriate time interval for discontinuation of drugs that slow intestinal motility and capsule endoscopy. However, in general, if it is anticipated that a patient will have slow passage of the capsule, it may be useful to use a prokinetic agent such as metoclopramide or erythromycin. These have been shown to be effective for patients with delayed gastric emptying.
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Are there known complications from large bowel capsule retention? I have been told that there are cases with capsule almost stationary in large bowel for months without complications or symptoms.
A: There are reports of the capsule being retained in the small bowel for prolonged periods, even over a year, without complication. I am not aware of reports of colonic retention, but a physician may elect endoscopic retrieval in such an event.
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In a patient with gastric bypass, are there special recommendations or precautions?
A: There have been isolated reports of delayed gastric passage of the capsule in such patients. Some doctors have used one time administration of prokinetic agents such as metoclopramide, erythromycin, etc. or endoscopic placement into the duodenum has also been performed.
Back
Is there a limit on the size of a patient's abdomen? We have a patient with a 60" waist that weighs 430 pounds. Will there be any problems with image capture?
A: Morbid obesity may impose a problem in reception by the sensors on the abdomen. It has been suggested that placement of sensors on the back may facilitate adequate reception in such an individual. Unfortunately, it cannot be predicted before the study whether obesity will interfere with the study.
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My hospital has a policy stating that a patient must first have either an EGD/Colonoscopy, or UGI/BE prior to capsule endoscopy. What is the recommendation of Given Imaging?
A: Capsule endoscopy may be used as a first line study in the detection of small bowel lesions. When it is unclear where the abnormality is located, it has been recommended that capsule endoscopy be performed after a negative EGD and colonoscopy. In patients with suspected IBD, the timing of a capsule endoscopy study is currently being investigated.
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