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

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia; GastroIntestinal Bleeding
• Interventions: Diagnostic Test: Pan-intestinal capsule endoscopy

• Registration Number: NCT04782986
• Lead Sponsor: Hospital da Senhora da Oliveira

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.

Study Timeline

• Study Start: 2020-06-19
• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Primary Completion: 2022-09-20
• Study Completion: 2023-01-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Conventional colonoscopy	Pan-intestinal capsule endoscopy	Same-day colonoscopy under propofol sedation
Pan-intestinal capsule endoscopy	Pan-intestinal capsule endoscopy	PillCam Crohn's capsule protocol

Primary Outcome Measures

Name	Time	Method
Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon	2 weeks	Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding

Secondary Outcome Measures

Name	Time	Method
Patient's preference: number of participants preferring capsule endoscopy or colonoscopy	2 weeks	Questionnaire regarding preference based on overall experience and perception of the strengths and limitations of each procedure
Safety: number of participants with any procedure-related adverse events	2 weeks	Adverse events include capsule retention, bowel preparation-related (nausea, vomiting, dizziness, seizures, abdominal pain or bloating), bleeding, perforation or cardiopulmonary complications

Trial Locations

Locations (1)

Gastroenterology Department, Hospital da Senhora da Oliveira; 🇵🇹 Guimarães, Portugal