NCT03501758: PRELAPSE

Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound

Status unknown Last updated 18 September 2019

What this trial tests

trial testing Ultrasound in Ulcerative Colitis in Remission in 40 participants. Status unknown.

Timeline

17 January 2017

Primary endpoint
30 December 2023

30 December 2023

Quick facts

Lead sponsor	Haukeland University Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	40
Start date	17 January 2017
Primary completion	30 December 2023
Estimated completion	30 December 2023
Sites	2 locations across Norway

Drugs / interventions tested

• Ultrasound
• Analysis of prouroguanyline and uroguanyline in full blood

Conditions studied

• Ulcerative Colitis in Remission — all drugs for Ulcerative Colitis in Remission →
• Ultrasound — all drugs for Ultrasound →
• Relapse/Recurrence — all drugs for Relapse/Recurrence →

Sponsor

Haukeland University Hospital

Who can join

18 and older, any sex, with Ulcerative Colitis in Remission or Ultrasound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.