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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782986
• Other study ID #: ERP-2020-12296
• Status: Completed
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2023
• Source: Hospital da Senhora da Oliveira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 31, 2023
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Iron Deficiency Anemia

Intervention

Diagnostic Test:
• Pan-intestinal capsule endoscopy
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

Locations

Country	Name	City	State
Portugal	Gastroenterology Department, Hospital da Senhora da Oliveira	Guimarães

Sponsors (2)

Lead Sponsor	Collaborator
Hospital da Senhora da Oliveira	Medtronic

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of bowel preparation at capsule endoscopy (small bowel)	Use of validated Brotz scale (4-grade qualitative assessment as excellent, good, fair or poor bowel preparation)	2 weeks
Other	Quality of bowel preparation at capsule endoscopy (colon)	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	2 weeks
Other	Quality of bowel preparation at colonoscopy	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)	2 weeks
Primary	Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon	Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding	2 weeks
Secondary	Safety: number of participants with any procedure-related adverse events	Adverse events include capsule retention, bowel preparation-related (nausea, vomiting, dizziness, seizures, abdominal pain or bloating), bleeding, perforation or cardiopulmonary complications	2 weeks
Secondary	Patient's preference: number of participants preferring capsule endoscopy or colonoscopy	Questionnaire regarding preference based on overall experience and perception of the strengths and limitations of each procedure	2 weeks