PEC: Diagnosis of Inflammatory Bowel Disease by Examining the Entire Bowel by Pan-intestinal Capsule Endoscopy

Sponsor

Robert Bosch Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04904224

Collaborator

Medtronic (Industry)

150

Enrollment

Locations

Arms

24.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to discover inflammatory changes in the gastrointestinal tract in adult patients with suspicion of a chronic inflammatory bowel disease (IBD) by examining the entire bowel, including the small intestine, by using a video capsule. The study compares the video capsule endoscopy with colonoscopy with the question of inflammation and patient satisfaction with the respective examinations.

The study is aimed at participants who present to a gastroenterologist because of their complaints like persistent abdominal pain or diarrhea. An infectious genesis and celiac disease must be ruled out in advance.

In addition, the determination of the fecal calprotectin (fCal) is necessary for this study. Fecal calprotectin is a stool marker for the severity of an inflammation of the gastrointestinal tract, an increased fecal calprotectin can be an initial indication for the presence of a chronic inflammatory bowel disease.

As mentioned above, participants will be examined in one of two ways: either with an examination of the small and large intestines using video capsule endoscopy in one examination (i.e. ,panintestinal capsule endoscopy', PICE) or a colonoscopy is performed as the standard treatment. Which of the two methods is used will be decided by lot, electronically controlled.

Colon cleansing is necessary in preparation for both examinations. The advantage of being assigned to the video capsule group is, in addition to showing the entire intestine in one examination, that no sedation is necessary for this examination.

In addition to the examination, participants have to fill out a questionnaire with information about their state of affairs, their well-being and their experience with the examination. After a period of six month the participants will be contact by phone to inquire about their current state of health.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Morbus Crohn	Device: Panintestinal video capsule endoscopy Device: Colonoscopy	N/A

Detailed Description

People who contact a gastroenterologist because of persistent complaints like abdominal pain or diarrhea are suspicious having an inflammatory bowel disease and maybe meet the eligibility requirements for the study.

After checking the inclusion and exclusion criteria further necessary data (medical history, secondary diagnoses, previous examinations, etc.) as well as laboratory parameters (especially signs of inflammation and fecal calprotectin) are collected. After being informed about the study and potential risks, all patients giving written informed consent and who meet the eligibility requirements will be randomized in an open-label manner (participant and investigator) in a 1:1 ratio to video capsule endscopy intervention or colonoscopy. A follow-up by phone to evaluate the state of health is planned after six months.

The study center and established specialist practices are responsible for the study inclusion.

There will be no recruitment by advertising. Only participants who are introducing themselves due to complaints are offered study participation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized multicentric open-label study in cooperation with local gastroenterological specialist practices. A comparison is made of pan-intestinal capsule endoscopy versus colonoscopy.Randomized multicentric open-label study in cooperation with local gastroenterological specialist practices. A comparison is made of pan-intestinal capsule endoscopy versus colonoscopy.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Use of Pan-intestinal Capsule Endoscopy for Detection of Inflammatory Bowel Disease in the Case of Increased Fecal Calprotectin

Actual Study Start Date :

Mar 7, 2021

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PICE Participants receive a panintestinal video capsule endoscopy (PICE)	Device: Panintestinal video capsule endoscopy Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic Other Names: PillCam Crohn's Capsule
Active Comparator: Colonoscopy Participants receive an (Ileo-)Colonoscopy	Device: Colonoscopy Performing a standard colonoscopy using the colonoscope available in the study center Other Names: (Ileo-)Colonoscopy

Arm

Intervention/Treatment

Active Comparator: PICE

Participants receive a panintestinal video capsule endoscopy (PICE)

Device: Panintestinal video capsule endoscopy

Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic

Other Names:

PillCam Crohn's Capsule

Active Comparator: Colonoscopy

Participants receive an (Ileo-)Colonoscopy

Device: Colonoscopy

Performing a standard colonoscopy using the colonoscope available in the study center

Other Names:

(Ileo-)Colonoscopy

Outcome Measures

Primary Outcome Measures

Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract [through study completion, an average of 1 year]
Detection of inflammatory changes using vidoe capsule endoscopy or colonoscopy

Secondary Outcome Measures

Number of Diagnosis of a Chronic Inflammatory Bowel Disease [through study completion, an average of 1 year]
Diagnosis of inflammatory bowel disease depending on the examination findings of video capsule endoscopy or colonoscopy
Number of Participants with Indication for a Therapy because of the Examination findings [through study completion, an average of 1 year]
Indication for a surgical or drug therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years or older
Apply one of the following
Chronic abdominal pain for at least 4 weeks, min. 3/10 points on a visual pain scale
Persistent diarrhea, Stool frequency of at least 4 per day
doctor visit due to the mentioned complaints
Exclusion of an infectious genesis or coeliac disease by serological testing or duodenal biopsy, if necessary
Consent to study participation
Fecal calprotectin > 50 µg/g

Exclusion Criteria:

Pregnancy
metastasized malignoma
terminal renal insufficiency, renal insufficiency requiring dialysis
swallowing disorder
age < 18 years
lack of consent
infectious genesis of symptomps
coeliac disease
Relative contraindication:
evidence of strictures, strictures or fistulas in the gastrointestinal tract in imaging or in high suggestive symptoms, e.g. Ileus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Praxis Gersemann	Ditzingen	Baden-Württemberg	Germany	71254
2	Praxis Escher	Leonberg	Baden-Württemberg	Germany	71229
3	Gastroenterologische Schwerpunktpraxis	Stuttgart	Baden-Württemberg	Germany	70190
4	Robert Bosch Medical Center	Stuttgart	Baden-Württemberg	Germany	70376
5	Gastroenterologie am Pragsattel	Stuttgart	Baden-Württemberg	Germany	70469
6	Ambulante Gastroenterologie	Stuttgart	Baden-Württemberg	Germany	70565