Clinical trial NCT04782986: Pan-intestinal Capsule Endoscopy Versus Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding
Official title: Pan-intestinal Capsule Endoscopy Versus Conventional Colonoscopy in Iron Deficiency Anemia or Overt GI Bleeding: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
GastroIntestinal Bleeding
Keywords: iron deficiency anemia
gastrointestinal bleeding
pan-intestinal capsule endoscopy
Lead sponsor: Hospital da Senhora da Oliveira
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2021-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Prospective, single-blinded, single center cohort study. All patients will undergo pan-intestinal capsule endoscopy followed by conventional colonoscopy with deep sedation in the same day, with no need for further bowel preparation.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon
timeFrame: 2 weeks
Secondary outcomes:
measure: Safety: number of participants with any procedure-related adverse events
timeFrame: 2 weeks
measure: Patient's preference: number of participants preferring capsule endoscopy or colonoscopy
timeFrame: 2 weeks
Other outcomes:
measure: Quality of bowel preparation at capsule endoscopy (small bowel)
timeFrame: 2 weeks
measure: Quality of bowel preparation at capsule endoscopy (colon)
timeFrame: 2 weeks
measure: Quality of bowel preparation at colonoscopy
timeFrame: 2 weeks
Locations:
city: Guimarães
country: Portugal
facility: Gastroenterology Department, Hospital da Senhora da Oliveira
Study officials:
affiliation: Gastroenterology Department, Hospital da Senhora da Oliveira - Guimarães, Portugal
name: Bruno Rosa, MD
role: PRINCIPAL_INVESTIGATOR
References: