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Completed

NCT Number: NCT04782986

Pan-intestinal Capsule Endoscopy Versus Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding

The authors hypothesize that in patients with iron deficiency anemia or gastrointestinal bleeding, pan-intestinal capsule endoscopy is a safe and well tolerated procedure that may improve diagnostic yield comparatively to the current standard invasive colonoscopy.

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Key information

About this study

Patients presenting with iron deficiency anemia (IDA) or overt GI bleeding are often submitted to conventional upper GI endoscopy and colonoscopy, followed by small bowel capsule endoscopy if diagnosis remains elusive. Recently, however, the possibility of performing pan-intestinal endoscopy using a video capsule that evaluates both the small bowel and the colon in a single non-invasive examination, opens new perspectives for the management of those conditions, particularly when the initial upper GI endoscopy has been non-diagnostic. The authors hypothesize that performing early pan-intestinal capsule endoscopy strategy may allow, in a safe and well tolerated manner, to identify which patients would benefit of further interventions, such as colonoscopy or invasive enteroscopy, guided by findings pre-identified at capsule examination. The study aims to evaluate whether pan-intestinal capsule endoscopy is superior to the current standard strategy of conventional colonoscopy after non-diagnostic upper endoscopy in patients with IDA or overt GI bleeding, regarding diagnostic yield, safety and tolerability.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients from external consultation, hospital ward or urgency department, with suspected GI bleeding presenting in the occult form as IDA (Hb <12.0 g/dL in female gender or <13.0 g/dL in male gender) and/or overt GI bleeding presenting as melaena and/or haematochezia, and with prior non-diagnostic upper GI endoscopy (esophagogastroduodenoscopy, EGD)

Exclusion criteria

  • Lack of informed consent
  • Suspected lesions at index EGD that could justify the anemia or digestive bleeding
  • Known history of gastroparesis or bowel dysmotility
  • Known or suspected intestinal stricture
  • Female patients with potential gynaecological source of bleeding causative of the clinical condition
  • Patients with severe malnutrition
  • Patients unable to walk at least for short periods and/or with neurological and/or psychiatric condition potentially favouring protocol deviations
  • Allergy or contra-indications to any of the drugs or products used in the study
  • Pregnancy or breastfeeding

Treatment and study plan

Pan-intestinal capsule endoscopy

Diagnostic Test

Patients with iron deficiency anemia or overt GI bleeding with non-diagnostic upper GI endoscopy will be submitted to same-day pan-intestinal capsule endoscopy using PillCam Crohn's Capsule (Medtronic) followed by conventional colonoscopy under propofol sedation

Other names: Conventional colonoscopy

Primary outcomes

  1. Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon

    Time frame: 2 weeks

    Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding

Secondary outcomes

  1. Safety: number of participants with any procedure-related adverse events

    Time frame: 2 weeks

    Adverse events include capsule retention, bowel preparation-related (nausea, vomiting, dizziness, seizures, abdominal pain or bloating), bleeding, perforation or cardiopulmonary complications

  2. Patient's preference: number of participants preferring capsule endoscopy or colonoscopy

    Time frame: 2 weeks

    Questionnaire regarding preference based on overall experience and perception of the strengths and limitations of each procedure

Other outcomes

  1. Quality of bowel preparation at capsule endoscopy (small bowel)

    Time frame: 2 weeks

    Use of validated Brotz scale (4-grade qualitative assessment as excellent, good, fair or poor bowel preparation)

  2. Quality of bowel preparation at capsule endoscopy (colon)

    Time frame: 2 weeks

    Use of validated scale CC-CLEAR (Colon Capsule CLEansing Assessment and Report) - quantitative scale: adequate bowel preparation if overall score >= 6 points, and >= 2 points in each bowel segment (right, transverse, and left colon). Overall 0-5 points inadequate; 6-7 points good; 8-9 points excellent bowel preparation

  3. Quality of bowel preparation at colonoscopy

    Time frame: 2 weeks

    Use of validated Boston Bowel Preparation Scale: quantitative scale 0-9 points - adequate bowel preparation if overall score >= 6 points, and >= 2 points in each bowel segment (right, transverse, and left colon)

Sponsors and collaborators

Lead sponsor

Unidade Local de Saúde do Alto Ave, EPE

Other

Collaborators

  • Medtronic

Registry information

Official study title

Pan-intestinal Capsule Endoscopy Versus Conventional Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding: a Prospective Cohort Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 4, 2021
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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