Use of PillCam ESO2 in Triaging Patients Present With Upper GIB

NCT02446678 | Completed

• 1 other identifier: ESO2
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background

• Patients presented to hospital with coffee ground vomiting and black stool may not be actually having upper gastrointestinal bleeding (UGIB)
• Hospital admission can be avoided if serious UGIB can be excluded
• To date, the only useful tool to triage patient for hospital admission in UGIB is by using clinical score such as Rockall score or Blatchford score
• These scores are cumbersome and only exclude the most benign cases, but they are not useful in differentiating those who needs intervention
• In our pilot study, investigators found that capsule endoscopy can be used to identify patients with fresh blood and real coffee ground substance in the stomach and it is superior to nasogastric tube
• Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy Objectives The current study is designed
• to validate capsule endoscopy is an effective method in identifying patients with UGIB
• to study whether the capsule endoscopy can reduce requirement of hospital admission in patients with suspected UGIB
• to study if capsule endoscopy can help to identify patients with UGIB that may require urgent (within 24 hours) endoscopy and intervention
• to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in the management of UGIB
• to compare the effectiveness of capsule endoscopy against Blatchford score in identifying patients with UGIB that may require endoscopic intervention.

Conditions

Upper Gastrointestinal Bleeding

Keywords

Gastrointestinal bleeding; emergency department; PillCam ESO2

Outcome Measures

Primary Outcomes (1)

• The number of patients requiring hospital admission

  Patients with evidence of significant bleeding will be admitted to ward and receive early endoscopy (EGD)

  24 hours

Secondary Outcomes (4)

• Clinical rebleeding

  30 days

• Mortality

  30 days

• Cost of management in different strategies

  One year

• Comparing the effectiveness of CE against Glasgow Blatchford score in identifying patients with UGIB that may require endoscopic intervention

  30 days

Study Arms (2)

Capsule group: PillCam ESO2

ACTIVE COMPARATOR

Perform capsule endoscopy and esophagogastroduodenoscopy will be preformed within 24 hours after capsule ingestion

Device: PillCam ESO2

Standard group

NO INTERVENTION

Perform standard esophagogastroduodenoscopy

Interventions

PillCam ESO2 DEVICE

Capsule endoscopy

Capsule group: PillCam ESO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual aged ≥ 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena

You may not qualify if:

• UGIB with hemodynamic shock (BP\<90mmHg and pulse\>120 per minutes) requiring urgent endoscopy,
• UGIB with fresh hematemesis requiring urgent endoscopy
• dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation,
• prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery.
• presence of an electromedical device (pacemaker or internal cardiac defibrillator),
• altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation medications, allergy to Maxolon, unwillingness to swallow the capsule, patient expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting the capsule, patient on medications that may coat the upper GI tract such as antacids or sucralfate, or inability to provide written informed consent.
• Allergy to Maxolon
• Patients with known Esophageal Varices or Gastric Varices with or without prior bleeding episodes
• Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or hepatocellular carcinoma or pancreatic cancer

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Related Publications (1)

• Sung JJ, Tang RS, Ching JY, Rainer TH, Lau JY. Use of capsule endoscopy in the emergency department as a triage of patients with GI bleeding. Gastrointest Endosc. 2016 Dec;84(6):907-913. doi: 10.1016/j.gie.2016.04.043. Epub 2016 May 6.

  PMID: 27156655 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Emergencies

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Jessica Y.L. Ching, MPH

  Chinese University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 18, 2015
• Study Start: November 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share