Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496516
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Transperineal Ultrasound for Assessing and Predicting Response in Hospitalized Patients with a Flare of Ulcerative Colitis
Sponsor:
Sunshine Coast Hospital and Health Service
Organization:
Sunshine Coast Hospital and Health Service
Study Overview
Official Title:
Transperineal Ultrasound for Assessing and Predicting Response in Hospitalized Patients with a Flare of Ulcerative Colitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
TAPAS-UC
Brief Summary:
Our aim is to determine how useful transperineal ultrasound is to assess the severity of inflammation in patients with ulcerative colitis At the moment there is a small amount of evidence showing it may be just as good as flexible sigmoidoscopy for this purpose It is a non-invasive test which means if it is equivalent it may reduce the need for invasive tests like flexible sigmoidoscopy in the future
Patients admitted to hospital with a flare of ulcerative colitis will be invited to participate Participants will undergo standard of care treatment and investigation In addition to this they will undergo a specialized non-invasive ultrasound test through the perineum TPUS as well as the abdomen TA-IUS The results from this will be compared to the current standard flexible sigmoidoscopy Patients will undergo repeat ultrasound and flexible sigmoidoscopy ten weeks after hospital discharge
We aim to show that transperineal ultrasound is useful for assessing disease severity and predicting the treatment course of hospitalized patients and may be able to replace flexible sigmoidoscopy in some circumstances
Patients admitted to hospital with a flare of ulcerative colitis will be invited to participate Participants will undergo standard of care treatment and investigation In addition to this they will undergo a specialized non-invasive ultrasound test through the perineum TPUS as well as the abdomen TA-IUS The results from this will be compared to the current standard flexible sigmoidoscopy Patients will undergo repeat ultrasound and flexible sigmoidoscopy ten weeks after hospital discharge
We aim to show that transperineal ultrasound is useful for assessing disease severity and predicting the treatment course of hospitalized patients and may be able to replace flexible sigmoidoscopy in some circumstances
Detailed Description:
Ulcerative colitis is a chronic inflammatory disorder of the colon from which patients may experience acute disease flares often requiring hospitalization These flares may be severe and require aggressive immunomodulatory therapy to reduce morbidity and mortality Disease severity is determined in-part by endoscopic severity and so flexible sigmoidoscopy is indicated at admission in patients presenting with a disease flare Not all patients respond to initial therapy and assessing therapeutic response has traditionally been based on clinical and laboratory parameters eg C-Reactive Protein stool frequency presence of blood In our institution after clinical and biochemical response we assess for mucosal healing using flexible sigmoidoscopy which is the treatment target set out in the STRIDE-2 guideline This is generally performed ten weeks after admission after stabilization on a maintenance treatment regimen and after steroids have been discontinued Endoscopic assessment is invasive and expensive and to optimize resource utilization there has been interest in alternative strategies to assess ulcerative colitis activity
Intestinal ultrasound IUS is a well-established imaging modality and has been shown to be sensitive and specific for colonic inflammation and correlates well with endoscopy in patients with ulcerative colitis A major limitation of trans-abdominal IUS TA-IUS is that assessment of the rectum is often difficult with suboptimal views due to the position of the rectum deep within the pelvis As ulcerative colitis nearly always involves the rectum and may not involve the remainder of the large bowel traditional trans-abdominal IUS may miss significant active disease Trans-perineal ultrasound offers an easy way to visualize the rectum and could serve as a useful adjunct to TA-IUS in the assessment of ulcerative colitis response to therapy reducing the need for endoscopic assessment at follow-up
To date there has been very little published data on TPUS in ulcerative colitis though initial evidence is promising Sagami et al reported a strong correlation between colonoscopy and TPUS for assessment of rectal inflammation in ulcerative colitis and reported excellent patient acceptability of TPUS with patients expressing a preference for this modality over flexible sigmoidoscopy These studies were conducted in a Japanese population and there are no similar data validating the use or acceptability of TPUS in other populations
Hypothesis
TPUS will provide similar diagnostic accuracy when compared with flexible sigmoidoscopy in patients hospitalized with ulcerative colitis
All patients admitted with a flare of ulcerative colitis who meet the study inclusion criteria will be offered participation in the trial as near as feasible to the time of admission Information regarding transperineal ultrasound and the data collected during the trial will be provided in written and verbal form and written consent will be obtained
Data will be collected at baseline including
Non identifiable demographic age sex and biometric weight body mass index
Laboratory values Haemoglobin C-Reactive protein Albumin ESR Platelets
Clinical data Stool frequency 24 hours presence of blood in stool presence of tachycardia heart rate over 90 beats per minute presence of fever
Disease and treatment data including date of diagnosis phenotype if known medical treatment to date present medical treatment
These data will also be recorded at day 3 and day 5 of hospitalization if the patient remains an inpatient and steroid response as defined by the Oxford criteria will be documented
All patients will undergo standard of care assessment of disease including screening for gastrointestinal infection and a baseline flexible sigmoidoscopy as near as possible to the time of hospitalization Disease extent and severity will be documented using the Ulcerative Colitis Index of Severity UCEIS score Management will be at the discretion of the treating gastroenterologist in line with international guidelines
Ultrasound At the first practical opportunity after admission all patients who consent and are enrolled will undergo transperineal ultrasound and transabdominal ultrasound This will be carried out in a private area with an additional hospital staff member present as a chaperone during the transperineal component of the examination Ultrasound will be carried out by an accredited intestinal ultrasound provider staff specialist gastroenterologist or inflammatory bowel disease fellow under supervision Transabdominal images will be acquired using a Canon Aplio i800 with low and high frequency curvilinear or linear probe selected at the discretion of the practitioner depending on bowel depth and image quality Transperineal images will be acquired using mid frequency microconvex probe
Ultrasound image acquisition
Unaffected segment - Two still images of each segment in longitudinal and transverse view
Affected segment - Cine loop of 3-10s in each segment Colour doppler Index CDI cine loop 5s Rectum - irrespective of affected or unaffected TA-IUS - two still images in cross section TPUS - two still images longitudinal 3-10s cine loop in longitudinal CDI 5s cine loop
Ultrasound data collected on each segment will include
Bowel wall thickness
Bowel wall doppler signal using the modified Limberg system
Bowel wall stratification
Presence of mesenteric fat echogenicity
Presence of localized lymph nodes
Disease severity will be calculated as per the Milan criteria
Follow up Approximately 10 weeks after admission repeat flexible sigmoidoscopy will be performed to assess response to treatment as per our current standard practice and disease extent and severity using the UCEIS score will be documented Laboratory data including albumin C-Reactive protein and Haemoglobin will be recorded In addition to this TA-IUS and TPUS will be performed and disease severity for each of these modalities will be documented as described above
Intestinal ultrasound IUS is a well-established imaging modality and has been shown to be sensitive and specific for colonic inflammation and correlates well with endoscopy in patients with ulcerative colitis A major limitation of trans-abdominal IUS TA-IUS is that assessment of the rectum is often difficult with suboptimal views due to the position of the rectum deep within the pelvis As ulcerative colitis nearly always involves the rectum and may not involve the remainder of the large bowel traditional trans-abdominal IUS may miss significant active disease Trans-perineal ultrasound offers an easy way to visualize the rectum and could serve as a useful adjunct to TA-IUS in the assessment of ulcerative colitis response to therapy reducing the need for endoscopic assessment at follow-up
To date there has been very little published data on TPUS in ulcerative colitis though initial evidence is promising Sagami et al reported a strong correlation between colonoscopy and TPUS for assessment of rectal inflammation in ulcerative colitis and reported excellent patient acceptability of TPUS with patients expressing a preference for this modality over flexible sigmoidoscopy These studies were conducted in a Japanese population and there are no similar data validating the use or acceptability of TPUS in other populations
Hypothesis
TPUS will provide similar diagnostic accuracy when compared with flexible sigmoidoscopy in patients hospitalized with ulcerative colitis
All patients admitted with a flare of ulcerative colitis who meet the study inclusion criteria will be offered participation in the trial as near as feasible to the time of admission Information regarding transperineal ultrasound and the data collected during the trial will be provided in written and verbal form and written consent will be obtained
Data will be collected at baseline including
Non identifiable demographic age sex and biometric weight body mass index
Laboratory values Haemoglobin C-Reactive protein Albumin ESR Platelets
Clinical data Stool frequency 24 hours presence of blood in stool presence of tachycardia heart rate over 90 beats per minute presence of fever
Disease and treatment data including date of diagnosis phenotype if known medical treatment to date present medical treatment
These data will also be recorded at day 3 and day 5 of hospitalization if the patient remains an inpatient and steroid response as defined by the Oxford criteria will be documented
All patients will undergo standard of care assessment of disease including screening for gastrointestinal infection and a baseline flexible sigmoidoscopy as near as possible to the time of hospitalization Disease extent and severity will be documented using the Ulcerative Colitis Index of Severity UCEIS score Management will be at the discretion of the treating gastroenterologist in line with international guidelines
Ultrasound At the first practical opportunity after admission all patients who consent and are enrolled will undergo transperineal ultrasound and transabdominal ultrasound This will be carried out in a private area with an additional hospital staff member present as a chaperone during the transperineal component of the examination Ultrasound will be carried out by an accredited intestinal ultrasound provider staff specialist gastroenterologist or inflammatory bowel disease fellow under supervision Transabdominal images will be acquired using a Canon Aplio i800 with low and high frequency curvilinear or linear probe selected at the discretion of the practitioner depending on bowel depth and image quality Transperineal images will be acquired using mid frequency microconvex probe
Ultrasound image acquisition
Unaffected segment - Two still images of each segment in longitudinal and transverse view
Affected segment - Cine loop of 3-10s in each segment Colour doppler Index CDI cine loop 5s Rectum - irrespective of affected or unaffected TA-IUS - two still images in cross section TPUS - two still images longitudinal 3-10s cine loop in longitudinal CDI 5s cine loop
Ultrasound data collected on each segment will include
Bowel wall thickness
Bowel wall doppler signal using the modified Limberg system
Bowel wall stratification
Presence of mesenteric fat echogenicity
Presence of localized lymph nodes
Disease severity will be calculated as per the Milan criteria
Follow up Approximately 10 weeks after admission repeat flexible sigmoidoscopy will be performed to assess response to treatment as per our current standard practice and disease extent and severity using the UCEIS score will be documented Laboratory data including albumin C-Reactive protein and Haemoglobin will be recorded In addition to this TA-IUS and TPUS will be performed and disease severity for each of these modalities will be documented as described above
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?:
False
Is an FDA AA801 Violation?:
None