Efficacy and Safety of Bowel Preparation for Patency Capsule in CD Patients Who Previously Failed Patency Capsule

Efficacy and Safety of Bowel Preparation for Patency Capsule in Crohn's Disease Patients Who Previously Failed Patency Capsule

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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Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease; Crohn Disease of Small Intestine

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

CD patients referred for PC before VCE

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CD patients referred for PC before VCE; 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
CD patients who failed to pass an initial protocol PC on a previous attempt.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of second PC passaging	The percentage of patients successfully passing the second PC test, among those who fail the first attempt.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PC retention	The rate of PC retention	3 years
VCE retention	The rate of VCE retention	3 years
Positive PC passage	The rate of positive PC in CD patients	3 years
Risk factors	Risk factors for positive PC	4 years

Collaborators and Investigators

• Sponsor: Shmuel Kivity, MD
• Investigators: Principal Investigator: Nitsan Maharshak, MD, Sourasky Medical Center and Tel-Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 0292-19-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No