The Role of Intestinal Ultrasound in Monitoring the Response to Biological Therapy in Patients With Ulcerative Colitis

NCT ID: NCT05606939

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-03-12

Brief Summary

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In this study, the investigators aim to evaluate the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis

Detailed Description

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Ultrasound examination is an easily accessible, non-invasive, radiation-free technique, and cheap imaging modality that is often chosen as the first diagnostic method in gastroenterology disease.

performance of bowel ultrasound use of two different probes: low-frequency convex probe (3.0-3.5 MHz) and high-frequency linear probe (5-17 MHz) .

Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract, which clinically contains Crohn's disease, ulcerative colitis, and other conditions. IBD is characterized by episodes of abdominal pain, diarrhea, bloody stools, weight loss, and the influx of neutrophils and macrophages that produce cytokines, proteolytic enzymes

Intestinal ultrasound has been shown to have high sensitivity and specificity in the detection or exclusion of intestinal inflammatory activity in IBD. advantages of intestinal ultrasound over other imaging modalities include non-invasiveness, rapid availability and low costs ,evaluation of bowel wall thickness, as well as stratification that reflects alterations in histopathology ulcerative colitis (UC). Visualization of the vascularization of the bowel using color Doppler sonography and, direct visualization of motility.

A study done : IUS is preferred for monitoring the disease course and for assessing short-term treatment response. Found that monitoring bowel wall thickening (BWT) alone has the potential to predict the therapeutic response.The primary therapeutic goal in UC is to induce and maintain long-term disease remission; however, there is no single treatment pathwayguidelines recommend the use of either conventional therapies (i.e., aminosalicylates ..etc)Or the use of biologic therapies ( infliximab.)

Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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intestinal ultrasound

All patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness as well as stratification and Visualization of the vascularization of the bowel using color Doppler sonography also visualization of motility.

Findings of intestinal ultrasound will be compared regrading colonoscopic findings

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study

* moderate to severe UC patients
* immunosuppressant or corticosteroid refractory disease
* those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy

Exclusion Criteria

* Patients with UC who are under age of 18 years' old
* Patients with UC who aren't eligible to biological therapy
* patients with complication of UC(fistula , intestinal obstruction , intestinal perforation ,……)
* Patient refuse to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abanoub Ayoub Melk

resident doctor at tropical medicine and gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Abanoub Melk

Role: CONTACT

01228261560

Magda Hasan, MD

Role: CONTACT

01066900939

References

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Zakeri N, Pollok RC. Diagnostic imaging and radiation exposure in inflammatory bowel disease. World J Gastroenterol. 2016 Feb 21;22(7):2165-78. doi: 10.3748/wjg.v22.i7.2165.

Reference Type BACKGROUND
PMID: 26900282 (View on PubMed)

Atkinson NSS, Bryant RV, Dong Y, Maaser C, Kucharzik T, Maconi G, Asthana AK, Blaivas M, Goudie A, Gilja OH, Nuernberg D, Schreiber-Dietrich D, Dietrich CF. How to perform gastrointestinal ultrasound: Anatomy and normal findings. World J Gastroenterol. 2017 Oct 14;23(38):6931-6941. doi: 10.3748/wjg.v23.i38.6931.

Reference Type BACKGROUND
PMID: 29097866 (View on PubMed)

Jauregui-Amezaga A, Rimola J. Role of Intestinal Ultrasound in the Management of Patients with Inflammatory Bowel Disease. Life (Basel). 2021 Jun 23;11(7):603. doi: 10.3390/life11070603.

Reference Type BACKGROUND
PMID: 34201630 (View on PubMed)

Novak KL, Nylund K, Maaser C, Petersen F, Kucharzik T, Lu C, Allocca M, Maconi G, de Voogd F, Christensen B, Vaughan R, Palmela C, Carter D, Wilkens R. Expert Consensus on Optimal Acquisition and Development of the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]: A Reliability and Inter-rater Variability Study on Intestinal Ultrasonography in Crohn's Disease. J Crohns Colitis. 2021 Apr 6;15(4):609-616. doi: 10.1093/ecco-jcc/jjaa216.

Reference Type BACKGROUND
PMID: 33098642 (View on PubMed)

Other Identifiers

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IUS in ulcerative colitis

Identifier Type: -

Identifier Source: org_study_id

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