Clinical trial NCT01085513: Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy
Official title: Intestinal Motility Evaluation by Endoluminal Image Analysis Using Capsule Endoscopy (CE-EIA): a Multi-center Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intestinal Abnormalities
Keywords: intestinal abnormalities
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 143
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients, and requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world.

A novel method for evaluation of intestinal motility has been developed based on endoluminal image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is fully automated by a computer program.

The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.

This technique needs now to be validated in a large multinational population, to further develop a robust discrimination algorithm for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.

This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.

Detailed description: Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility1,2,3,11, and identifies patterns of intestinal dysmotility4,8,9. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients. Furthermore, it requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world6,7,10,13.

Vall d'Hebron Hospital, in collaboration with CVC (Barcelona, Spain) have recently developed a minimally invasive method for evaluation of intestinal motility based on endoluminal image analysis using the endoscopic PillCam capsule. In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is performed fully automated by a computer program. Both the technical procedure of the test and the endoluminal image analysis program has been developed by a multidisciplinary medical-engineering team in the Autonomous University of Barcelona over the past 5 years. The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.

In brief, the technique works as follows. In each study a series of features are analyzed: contractile patterns (contractions evaluated as a diaphragmatic occlusion of the lumen and by the presence of a radial wrinkle pattern), non contractile patterns (wall and tunnel patterns), luminal content (turbid pattern), endoluminal motion, and capsule displacement.

The program is based on an automated learning method (machine learning technique). Data from patients and healthy subjects are used as a training set. Based on these data, the program develops the function that best discriminates both groups. The performance of the system has been validated using the leave-one-out method that uses all but one as training set and evaluates the left-out example.

This technique needs now to be validated in a large multinational population. Using this expanded pool of studies as a learning set, a robust discrimination algorithm will be developed, that can be made available for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic5,12 and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.

This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.

Eligibility criteria: Inclusion criteria - Patients

* Patient's age is 16-80 years, inclusive.
* One of the following SB manometry procedures:

  * Underwent SB manometry within five years if results were abnormal
  * Underwent SB manometry within 1 year if results were normal
  * Scheduled for SB manometry within six months of enrollment date
* Patient was indicated for small bowel manometry based on one or both of the following symptoms:

  * Pseudo obstruction of the small bowel: symptoms resembling mechanical small bowel obstruction without evidence of luminal compromise of the gut. Mechanical occlusion is ruled-out by endoscopic and / or radiological studies following the criteria of the attending physician.

Patients may have any of the following:

* recurrent acute episodes (at least two) with air fluid levels (as evidenced at least once by abdominal X-ray), or
* chronic symptoms with small bowel dilation resembling a partial mechanical obstruction.

Patients will be tested during period of (non-acute) remission. - Chronic severe GI symptoms with inability to maintain normal body weight: abdominal symptoms (such as nausea, abdominal distension, discomfort or pain) produce inability to maintain a normal body weight as defined by unintentional weight loss of at least 10% of original body weight before onset of symptoms or a BMI \< 18.5, while on a normal diet (without oral dietary supplements, enteral or parenteral feeding).

These should be chronic symptoms lasting at least 6 months.

- Patient or legal guardian agrees to sign consent form

Exclusion criteria - Patients

* Acute exacerbation of chronic obstructive symptoms.
* Mechanical obstruction of any kind such as definite long stricture seen on radiological exam.
* Suspected GI stricture, followed by Agile® study that could not prove patency of the GI tract.
* Known history of small bowel organic disease such as Crohn's Disease or Celiac.
* Patient suffers from any condition, such as swallowing problems or having an implanted cardiac pacemaker or defibrillator which precludes compliance with study and/or device instructions.
* Non-steroidal anti-inflammatory drugs including aspirin, (twice weekly or more) during the 4 weeks preceding the CE exam.
* Patient has undergone gastrectomy (segmental small bowel resection over 30%).
* During the period between small bowel manometry and Capsule endoscopy, the patient has undergone any abdominal surgical procedures other than appendectomy, cholecystectomy, abdominal wall hernia repair or catheter placing for enteral feeding.
* Manometry was performed before any other allowed GI procedure.
* Patient is pregnant.
* Known abuse of alcohol or illicit substances.
* Patient presently presenting with an acute life threatening condition.
* Participating in another clinical study within 30 days.

Inclusion criteria - Healthy Volunteers

* Volunteer's age is 16-80 years, inclusive.
* Volunteer or legal guardian agrees to sign consent form. 6.5.2 Exclusion criteria - Healthy Volunteers
* Known diabetes mellitus
* Recurrent Gastrointestinal symptoms
* Volunteer suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions
* Non-steroidal anti-inflammatory drugs including aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
* More than one answer above 'mild' on the healthy volunteer symptoms questionnaire (Appendix C).
* Female volunteer is pregnant
* Known abuse of alcohol or illicit substances.
* Participating in another clinical study within 30 days

Primary outcomes:
measure: To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility
timeFrame: Up to 7 months
Secondary outcomes:
measure: To Assess Correlation Between Patient Clinical Symptoms and CE-EIA
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Division of Gastroenterology and Hepatology Mayo Clinic
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic,
state: Minnesota
city: Leuven
country: Belgium
facility: Center for GI Research, KU Leuven,
city: Bologna
country: Italy
facility: Internal Medicine & Gastroenterology, University of Bologna,
city: Barcelona
country: Spain
facility: Autonomous University of Barcelona
city: Göteborg
country: Sweden
facility: Departement of Internal Medicine, Sahlgrenska Universitetss
Study officials:
affiliation: Universitat Autonoma de Barcelona
name: Fernando Azpiroz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: