A Pilot and Feasibility Study to Evaluate Capsule Endoscopy (MA-79)

A Pilot and Feasibility Study to Evaluate Capsule Endoscopy in Subjects Presenting With Acute, Overt Upper Gastrointestinal Hemorrhage

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.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Hemorrhage
• Intervention / Treatment: Device: PillCam ESO2

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • N.t.
    • Shating, N.t., Hong Kong
      • Prince of Wales Hospital, Hong Kong, China
• Israel
  • Haifa, Israel, 31096
    • Rambma Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients to undergo PillCam procedure; Patients presenting to ER with acute overt upper GI bleeding	Device: PillCam ESO2; The capsule to be tested in this proposed study, PillCam ESO 2 capsule Endoscopy, is an improved version with exactly the same dimensions as the current PillCam ESO capsule, both in length and diameter.; Other Names: PillCam ESO 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Identification of gross blood (fresh or coffee grounds) / active bleeding in the esophagus, stomach and /or duodenum by PillCam™ ESO 2 and NG aspirate	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Suspected anatomic location of acute overt UGI bleeding (e.g., esophageal, gastric, and/or duodenal location) by PillCam™ ESO 2 and EGD.	7 days
Determination of suspected variceal vs. non-variceal source of acute overt UGIH by PillCam™ ESO 2 and EGD.	7 days
Number, type and severity of adverse events and number of PillCam™ ESO 2 capsules that reached the 2nd portion of the duodenum.	7 days
Patient subjective assessment questionnaires	7 days

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Josheph Sung, MD,PhD, Prince of Wales Hospital, Hong Kong, China; Principal Investigator: Ian Gralnek, MD., PhD., Rambam Medical Center, Haifa, Israel

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: September 9, 2009
• First Submitted That Met QC Criteria: September 9, 2009
• First Posted (Estimate): September 10, 2009

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: symptoms of acute overt upper gastrointestinal hemorrhage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: MA-79