An Observer Blinded Comparison of MACE and Conventional Upper Gastrointestinal Endoscopy in Upper GI Bleeding

NCT02690376 | Completed

• 1 other identifier: STH19107
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI disorders. But it is uncomfortable for patients and incurs the risk of intubation and sedation, plus a large proportion of procedures reveal insignificant or no pathology. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well-tolerated. The use of CE is traditionally restricted to the small bowel, although newer capsules to image the oesophagus and colon are currently in use. Previous capsules have failed to adequately image the stomach due to its' large volume and rugal folds. Recently a magnetic capsule and handheld magnet has been developed (Mirocam Navi, Intromedic Ltd, Seoul, Korea) to enable an element of manoeuvrability of the capsule. This is unnecessary in the small bowel where the capsule is propelled along its' tubular structure by peristalsis, but in the capacious stomach this may allow the capsule to be steered to examine all areas of the stomach. We have already conducted two feasibility studies in porcine models with promising results and a trial has already evaluated the equipment to steer the small bowel capsule through the stomach into the duodenum. An ongoing study is comparing the ability of this technique to examine the stomach against conventional OGD, in patients with recurrent iron deficiency anaemia. The next stop would be to compare the two modalities under other different conditions. We wish to undertake a prospective single blind controlled trial comparing magnetically assisted capsule examination to conventional OGD in diagnosing upper gastrointestinal pathology in patients with gastrointestinal bleeding.

Conditions

Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of pathology of MACE compared to gastroscopy.

  Baseline - one visit only

Secondary Outcomes (5)

• Mucosal visualisation of the oesophagus and major areas of the stomach during MACE.

  Baseline - one visit only

• Determine the number of patients with small bowel bleeding

  Baseline - one visit only

• Tolerability of MACE compared to gastroscopy

  Baseline - one visit only

• Duration of MACE compared to gastroscopy

  Baseline - one visit only

• Determine if MACE can be used to avoid unnecessary OGD or hospital admission

  Baseline - one visit only

Study Arms (1)

Magnetic Assisted Capsule Endoscopy

OTHER

There is only one arm and its does not reach criteria for other options

Device: Magnetic Assisted Capsule Endoscopy

Interventions

Magnetic Assisted Capsule Endoscopy DEVICE

Swallowed magnetic capsule for endoscopy purposes

Also known as: MACE

Magnetic Assisted Capsule Endoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and over
• Patients presenting with haematemesis (fresh blood or coffee grounds) and/or malaena within the previous 48 hours, who require a gastroscopy as part of their diagnostic investigations

You may not qualify if:

• Patients under the age of 18 years or over the age of 80 years.
• Patients who have a suspected UGIB and haemodynamic instability, i.e. hypotension (systolic blood pressure \<100mmHg) and tachycardia (\>100 bpm), requiring urgent resuscitation
• Pre-endoscopy Rockall score \>4 (patients with a lower pre-endoscopy Rockall score but haemodynamically unstable will still be excluded)
• Active vomiting or haematemesis
• Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device
• Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
• Patients with dysphagia, odynophagia or known swallowing disorder
• Patients with known Zenker's diverticulum
• Patients with suspected bowel obstruction or bowel perforation
• Patients with prior bowel obstruction
• Patients with gastroparesis or known gastric outlet obstruction
• Patients with known Crohn's disease
• Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure)
• Patients that are pregnant or lactating
• Patients with altered mental status that would limit their ability to swallow

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• IntroMedic USA Inc.: collaborator

Study Sites (2)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Sheffield Teaching Hospitals FT Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (1)

• Ching HL, Hale MF, Sidhu R, Beg S, Ragunath K, McAlindon ME. Magnetically assisted capsule endoscopy in suspected acute upper GI bleeding versus esophagogastroduodenoscopy in detecting focal lesions. Gastrointest Endosc. 2019 Sep;90(3):430-439. doi: 10.1016/j.gie.2019.04.248. Epub 2019 May 10.

  PMID: 31082392 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mark McAlindon, Dr

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)