Clinical trial NCT00974701: A Pilot and Feasibility Study to Evaluate Capsule Endoscopy
Official title: A Pilot and Feasibility Study to Evaluate Capsule Endoscopy in Subjects Presenting With Acute, Overt Upper Gastrointestinal Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Hemorrhage
Keywords: symptoms of acute overt upper gastrointestinal hemorrhage
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is aimed at assessing the capability of the PillCam Platform using the PillCam ESO 2 Capsule in:

* Determining whether there is 1) active bleeding in the Upper gastrointestinal (UGI) tract, 2) identifying the anatomic location of acute overt UGI bleeding, and 3) discriminating a variceal versus non-variceal source of UGI bleeding.

Detailed description: Upper gastrointestinal hemorrhage (UGIH) is a prevalent, clinically significant, and expensive healthcare problem worldwide. The incidence of acute, overt UGIH has been estimated to be 50-150 cases per 100,000 adults in the United States population each year.

Clinical Significance / Rationale EGD is the currently accepted community standard for the diagnosis and management of UGIH. Diagnostic EGD in persons presenting with acute UGIH allows for (1) differentiating the source of bleeding (variceal vs. non-variceal), (2) defining the anatomic location of the bleeding site (e.g., esophagus, stomach, duodenum), (3) providing an endoscopic diagnosis, and (4) facilitating patient triage for subsequent level of care (ICU, monitored bed, non-monitored bed, early / expedited hospital discharge).

Capsule endoscopy for the small bowel was cleared by the FDA in 2001, and within a short time, has gained acceptance as providing state-of-the-art endoscopic imaging. Capsule endoscopy is now commonly used in the evaluation of patients with obscure gastrointestinal bleeding, including iron deficiency anemia, suspected and known Crohn's disease, malabsorption syndromes (e.g., Celiac disease), and chronic abdominal pain. Capsule endoscopy technology is now also being applied to evaluation of the esophagus (PillCam® ESO, Given Imaging, Ltd, Yoqneam, Israel) and the colon (PillCam® COLON). Recently, a second generation esophageal capsule endoscope (PillCam® ESO 2, Given Imaging Ltd, Yoqneam, Israel) was cleared by the United States Food and Drug Administration in June 2007. While having the same outer dimensions (length and diameter) as the original PillCam ESO capsule, several significant improvements have been made to the internal components of the PillCam ESO 2. Similar to the original PillCam ESO, the system includes a sensor array and data recording device which are connected to the patient during the procedure. The recorded data is downloaded into the Given Imaging RAPID® workstation for review of the capsule endoscopy video.

However, there are no published detailed data evaluating the feasibility of utilizing PillCam ESO 2 in individuals presenting with acute, overt UGI bleeding. Moreover, there are no data comparing PillCam ESO 2 and EGD in the evaluation of this patient population. Therefore, in this proof-of-concept pilot study, we will evaluate the feasibility and safety of using PillCam ESO 2 in individuals presenting with acute, overt UGI bleeding.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* history of acute, overt UGI hemorrhage, defined as hematemesis (fresh blood or coffee grounds) and/or melena within the 48 hours prior to patient presentation

Exclusion Criteria:

* dysphagia
* odynophagia
* known swallowing disorder
* history of Zencker's diverticulum
* suspected bowel obstruction or bowel perforation at the time of presentation
* UGI hemorrhage with hemodynamic shock requiring urgent endoscopy
* history of prior bowel obstruction
* history of Crohn's disease
* history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
* presence of an electromedical device (pacemaker or internal cardiac defibrillator)
* altered mental status (e.g., hepatic encephalopathy) at the time of presentation that would limit patient ability in swallowing the capsule
* pregnancy
* known allergy to conscious sedation medications
* known allergy to erythromycin
* inability to provide written informed consent

Primary outcomes:
measure: Identification of gross blood (fresh or coffee grounds) / active bleeding in the esophagus, stomach and /or duodenum by PillCam™ ESO 2 and NG aspirate
timeFrame: 7 days
Secondary outcomes:
measure: Suspected anatomic location of acute overt UGI bleeding (e.g., esophageal, gastric, and/or duodenal location) by PillCam™ ESO 2 and EGD.
timeFrame: 7 days
measure: Determination of suspected variceal vs. non-variceal source of acute overt UGIH by PillCam™ ESO 2 and EGD.
timeFrame: 7 days
measure: Number, type and severity of adverse events and number of PillCam™ ESO 2 capsules that reached the 2nd portion of the duodenum.
timeFrame: 7 days
measure: Patient subjective assessment questionnaires
timeFrame: 7 days
Other outcomes:
Locations:
city: Shating
country: Hong Kong
facility: Prince of Wales Hospital, Hong Kong, China
state: N.t.
city: Haifa
country: Israel
facility: Rambma Medical Center
Study officials:
affiliation: Prince of Wales Hospital, Hong Kong, China
name: Josheph Sung, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Medical Center, Haifa, Israel
name: Ian Gralnek, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: