Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125678
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-05
Brief Title:
Correlation of Cross Sectional Imaging and Small Intestinal Contrast Ultrasonography in Known Crohns Disease
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
Correlation and Assessment of Small Bowel Lesion Using Cross Sectional Imaging Techniques Compared to Small Intestinal Contrast Ultrasonography in Known Small Bowel Crohns Diseasethe CACTUS-CD Trial a Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CACTUS-CD
Brief Summary:
Small intestinal contrast ultrasound SICUS is a modality of intestinal ultrasound IUS which does not require any parenteral administration of contrast agent but requires ingestion of around 500 ml of polyethylene glycol PEG SICUS does not involve any radiation Computed tomography enteroclysis CTE requires colonic cleansing using polyethylene glycol PEG followed by infusion of 15 litres of PEG via a nasal catheter to distend and properly visualise the small intestine CTE although accurate for assessing response to therapy and transmural healing in small bowel CD is associated with radiation and adds to cost of management Magnetic resonance enterography MRE using PEG followed by 2 liters of oral fluid with mannitol was administered to distend and properly visualize the small intestine MRE although accurate for assessing response to therapy and transmural healing in small bowel CD is associated with radiation and adds to cost of management On the other hand SICUS is relatively non-invasive method of small bowel assessment although the accuracy has not been studied prospectively An earlier retrospective study in which MRECTE and SICUS are done within 3 months of each other SICUS had identified lesions and complications in patients with CD with high levels of sensitivity specificity and accuracy compared to CT-enteroclysis 3 These findings need prospective validation The accuracy of SICUS may be suboptimal due to constant peristalsis in the small intestine Hence the investigators planned this study to perform SICUS in patients with small bowel CD who otherwise require a MRECTE for disease monitoring on the same day before the procedure with the same PEG preparation If SICUS findings are found to correlate with MRECTE findings intros study SICUS have the potential to replace other modalities for monitoring of small bowel Crohns disease CD and emerge as a cost-effective easy alternative The investigators also want to understand the drawbacks and limitations of SICUS in this scenario
Detailed Description:
Diagnosis CD site and patients management shall be made according generally accepted recommendations4 SICUS shall be performed in all participants by one independent experienced operator MAM Colonic cleansing shall be done on night before the examination with Polyethylene glycol PEG solution 1 litre The participants shall be examined after the ingestion of 375 mL range 250-500 mL of polyethylene glycol PEG in the morning using a convex transducer 2-6 MHz and a high frequency linear-array transducer for details 5-14 MHz Median SICUS duration shall be noted SICUS shall be performed without any additional charges to the participant CT-Enteroclysis shall be performed in all participants by one independent experienced operator UK A 20G needle shall be placed in an antecubital vein and 8-F nasojejunal catheter with aTeflon-covered guide wire shall be positioned under fluoroscopic guidance with the distal extremely located in the distal duodenumproximal jejunum Afterward the patient shall be taken into the CT room where hypodense contrast material 1500 mL of PEG shall be administered manually with 60-mL syringes with a constant and continuous injection rate of 150 mLmin followed by a flow rate of 200 mLmin until the maximum tolerance of the patient Just before the examination participants shall receive a smooth muscle relaxant N butyl 4 scopolamine to prevent spasms achieve uniform small bowel distension and reduce abdominal discomfort The study shall be performed by a 64-slice multidetector CT with the following scan parameters collimation 125 mm table feed 3937 mmrot 120 kV 300 mAspitch 09841 rotation time 05 s time of acquisition 125 s FOV 50 cm matrix 512x512 After the infusion of PEG CT scan seal be performed before and after the administration of intravenous iodinated contrast material The contrast-enhanced study shall be acquired 70s after the administration of contrast material Ultravist 370 Schering AG Berlin Germany Median CT-Enteroclysis duration shall be recorded Magnetic Resonance enterography MRE shall be performed in all participants by one independent experienced operator The participant shall be fasted for 4-6 h prior to the study In adults 2 liters of oral fluid with mannitol shall be administered to distend the bowel loops Just before the examination participants shall receive a smooth muscle relaxant Buscopan to prevent spasms achieve uniform small bowel distension and reduce abdominal discomfort T2 BTFEaxial and coronal sequencediffusion weighted imaging DWICoronal sequence Post contrast Axial Coronals and sagittal sequence will be takenMedian MRE duration shall be recordedThe site of small bowel involvement maximal bowel wall thickness and complications like stricture and fistula detected by SICUS and MRECTE shall be collected and correlated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None