Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515171
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Efficacy and Safety of Bowel Preparation for Patency Capsule in CD Patients Who Previously Failed Patency Capsule
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Bowel Preparation for Patency Capsule in Crohns Disease Patients Who Previously Failed Patency Capsule
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
Crohns 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None