An observational study in Crohn Disease and Crohn Disease of Small Intestine, sponsored by Shmuel Kivity, MD. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Shmuel Kivity, MD · Observational
The goal of this observational study is to evaluate the success rate of a second bowel preparation protocol for patency capsule (PC) in Crohn Disease (CD) patients who failed to pass an initial protocol PC on a previous attempt.
The main question it aims to answer is what is the percentage of patients successfully passing the second PC test, among those who failed the first attempt.
Participants who will fail the PC test will be scheduled for another test with a different preparation protocol.
Participants will be asked to report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing.
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Crohn's disease (CD) involves the entire length of the gastrointestinal tract, including a large proportion of patients with small bowel involvement. Most of the small bowel length is not accessible by conventional endoscopy for diagnosis and routine follow-up. During their lifetime these patients require repeated evaluation of disease activity and extent. Traditionally this evaluation is achieved by periodic CT or MR enterography that involves repeated exposure to radiation and contrast materials and does not provide good mucosal assessment. The use of video capsule endoscopy (VCE) among CD patients provides a good mucosal assessment without exposure to radiation or contrast material, or the risks of conventional endoscopy and sedation.
The caveat of VCE in CD is the concern of capsule retention due to strictures which are sometimes asymptomatic. This is more pronounced in patients with clinical or radiographic features implying small bowel obstruction: stricturing /fistulizing disease phenotype, abdominal pain and bloating after meals, improvement with liquid diet, stenosis and proximal dilatation on imaging studies. In these high-risk patients a patency capsule (PC) test is recommended prior to VCE. The PC is a capsule in similar dimensions to that of the VCE which contains radio-opaque components and a cellophane coat that dissolves after approximately 30 hours. Patients failing to pass the pill after 30 hours continue assessment with plain abdominal X-ray imaging or a dedicated scanner in order to confirm or deny PC expulsion. If the test is positive and the PC was not expelled, the recommendation is to avoid VCE use and limit the patient to periodical imaging and conventional endoscopy as mentioned earlier. The probability for a positive PC test is 20-30% in high risk CD patients and thus, paradoxically, some of the patients who may benefit the most from VCE, will not undergo it. Nevertheless, VCE retention rate is estimated to occur in \~ 2% of patients. However, both PC and VCE are considered safe procedures and complications even in case of capsule retention are rare.
Given that the normal transit time of the entire digestive tract is up to 72 hours, delayed expulsion of the PC (i.e. >30 hours) can simply be due to slow transit or large amount of content in the large bowel and not a small bowel obstruction. Currently there are no guidelines regarding PC preparation protocol, but It seems slow transit can probably be overcome by bowel preparation.
In the endoscopic capsule unit of the TLVMC, we implement routinely a second attempt for bowel preparation, in CD patients who fail their first attempt to pass the capsule. Studies evaluating the safety and efficacy of this protocol is lacking.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's planned enrollment of 400 is above the median of 166 across 624 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Shmuel Kivity, MD is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CD patients referred for PC before VCE
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No intervention will be administered. Endoscopic capsule protocol will be performed in a uniform manner on all participants in the study as part of their routine clinical evaluation regardless of the study. The patient will report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing
All the patients who failed the PC test will be scheduled for another test with a different preparation protocol, a common practice also today. This will be done as a standard procedure, in the clinical setting of the endoscopic capsule clinic and not as part of the study. Again, the patient will report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing. If the second test was positive as well, an abdominal x-ray will be performed within 2 weeks to rule out PC retention - standard protocol for PC retention.
Rate of second PC passaging
The percentage of patients successfully passing the second PC test, among those who fail the first attempt.
Time frame: 3 years
PC retention
The rate of PC retention
Time frame: 3 years
VCE retention
The rate of VCE retention
Time frame: 3 years
Positive PC passage
The rate of positive PC in CD patients
Time frame: 3 years
Risk factors
Risk factors for positive PC
Time frame: 4 years
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2019 (actual). Primary completion is estimated for Dec 2024, 62 months after the start.
Of 223 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 90. This study's planned 62 months is above that.
Counting every sponsor, half of 296 studies reached it within 42 months; a quarter within 29 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Shmuel Kivity, MD