Clinical trial NCT00476398: Evaluation of Patients With Non-cardiac Chest Pain
Official title: Evaluation of Patients With Non-cardiac Chest Pain Using PillCam Eso - a Wireless Imaging Capsule of the Esophagus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Cardiac Chest Pain
Gastroesophageal Reflux Disease
Keywords: Capsule endoscopy
Wireless imaging
esophagus
stomach
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2007-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find out how common diseases of the esophagus can cause chest pain. Gastroesophageal reflux disease (GERD), commonly known as heartburn, is a common cause of chest pain in patients that do not have heart problems. The study test is called PillCam Eso, it is a small, pill sized capsule that has a small camera inside it. The camera will take pictures of the esophagus and the stomach as it goes down. Findings of the PillCam Eso will be compared to findings during conventional upper endoscopy.

Detailed description: Non-cardiac chest pain (NCCP) is defined by recurrent episodes of retrosternal chest pain in the absence of significant cardiovascular disease after a thorough cardiac evaluation. It accounts for 2-5% of all emergency department visits. Studies examining the prevalence of esophago-gastric lesions in patients with NCCP referred to gastroenterologists have found esophagitis, esophageal ulcers, hiatal hernias, gastritis, and gastric ulcers in 62% of patients. Advances in endoscopic technologies, particularly, the introduction of the wireless video-capsule (PillCam Eso) allows for the possibility of direct visualization of the upper gastrointestinal tract in the emergency department. During capsule endoscopy, a patient will swallow a pill-sized video-capsule, the wireless images of the gastrointestinal tract are transmitted to a computer. Findings of the PillCam Eso will be then compared to findings during conventional upper endoscopy.

Eligibility criteria: Inclusion Criteria:

* age 18 to 80 years
* negative cardiac evaluation in the emergency department
* pre-established access to a primary care provider
* ability to give informed consent

Exclusion Criteria:

* known history of ischemic heart disease
* proton pump inhibitor therapy
* known or suspected obstructions or strictures in the gastrointestinal tract, including a history of Crohn's disease, gastrointestinal surgery other than cholecystectomy or appendectomy.
* permanent pacemakers/defibrillators or other implantable wireless devices
* known pregnancy
* unstable medical conditions
* inability to follow instructions
* active psychiatric conditions that preclude participation in the study

Primary outcomes:
measure: endoscopy for evaluating the prevalence of esophago-gastric lesions in patients
timeFrame: 60 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Julia J. Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: