Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound

Summary

Rationale:

Ulcerative colitis (UC) is remitting disease with a variable course. Predicting disease relapse after remission is important for the adjustment of medical treatment. Ileocolonoscopy is the best tool for doing this, but due to its invasiveness should be replaced by a method better accepted by the patient. Gastrointestinal ultrasound (GIUS) could be such a method.The PRELAPSE study will include UC patients who have been on maintenance anti-TNF therapy for at one year or more and in clinical remission for the 3 past months at least in two centres, Haukeland University Hospital and Ålesund Hospital. The infrastructure for recruiting these patients has already been established in the BIOSTOP study (Protocol ID no: HMR2016-0.6 and EudraCT (European Clinical Trials Database) no: 2016-001409-18).

Objective:

To study if GIUS or individual US parameters can predict endoscopic relapse at follow up examinations in a group of patients with ulcerative colitis in sustained clinical and endoscopic remission

Study design:

Prospective, longitudinal, explorative, observational multi-centric study for diagnostic accuracy Study population: Adult patients with histo-pathologically confirmed diagnosis of UC between 18 and 80 years of age that have entered the BIOSTOP trial (Trial number: EudraCT: 2016-001409-18) will be considered for inclusion in the proposed study.

Intervention:

All patients will be subjected to trans-abdominal gastrointestinal ultrasound and ileocolonoscopy. Blood and faeces samples will be collected at one time point for measuring relevant inflammatory markers.

Main study parameter: Ultrasound measurements of the intestine of patients with ulcerative colitis Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will be examined repeatedly with gastrointestinal ultrasound (GIUS) and at certain time points with ileocolonoscopy or sigmoidoscopy. As all these procedures already are scheduled as a part of the BIOSTOP study the only extra burden for the patients will be the ultrasound examination. GIUS is a safe procedure that uses high frequency sound waves for the visualization of internal organs. The implementation of GIUS for the assessment of disease activity in UC patients might result in a reduced need for ileocolonoscopy, thereby reducing costs and the burden for patients. Compared to invasive endoscopic procedures GIUS can be performed without preparation, which is an advantage for the patients as treatment decisions can be made without delay. GIUS is also cheaper than ileocolonoscopy, causes little discomfort and has few or no complications.

Conditions

• Ulcerative Colitis in Remission
• Ultrasound
• Relapse/Recurrence

Interventions

DIAGNOSTIC_TEST

Ultrasound

Transabdominal ultrasound of the bowel for categorisation of disease activity

DIAGNOSTIC_TEST

Analysis of prouroguanyline and uroguanyline in full blood

Withdrawal of full blood at each study visit, Storage in biobank. Analysis of prouroguanyline and proguanyline.

Sponsors & Collaborators

• Alesund Hospital

  collaborator OTHER

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Kim Nylund, PhD · Dep. of Medicine, Haukeland University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-17

Primary Completion

2023-12-30

Completion

2023-12-30

Countries

• Norway

Study Locations