Clinical trial NCT06515171: Efficacy and Safety of Bowel Preparation for Patency Capsule in CD Patients Who Previously Failed Patency Capsule
Official title: Efficacy and Safety of Bowel Preparation for Patency Capsule in Crohn's Disease Patients Who Previously Failed Patency Capsule
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Crohn Disease of Small Intestine
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-07-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CD patients referred for PC before VCE

Brief summary: 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.

.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

• Crohn Disease patients intendent to perform Capsule endoscopy .

Exclusion Criteria:

* Severe obstructive symptoms according to physician discretion
* Pregnancy
* Inability to sign informed consent
* Inability to complete the VCE procedure

Primary outcomes:
measure: Rate of second PC passaging
timeFrame: 3 years
Secondary outcomes:
measure: PC retention
timeFrame: 3 years
measure: VCE retention
timeFrame: 3 years
measure: Positive PC passage
timeFrame: 3 years
measure: Risk factors
timeFrame: 4 years
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Sourasky Medical Center and Tel-Aviv University
name: Nitsan Maharshak, MD
role: PRINCIPAL_INVESTIGATOR
References: