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

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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia; GastroIntestinal Bleeding
• Intervention / Treatment: Diagnostic test: Pan-intestinal capsule endoscopy

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Rosa, MD; Phone Number: +351914155893; Email: bruno.joel.rosa@gmail.com

Study Locations

• Portugal
  • Guimarães, Portugal, 4835-044
    • Gastroenterology Department, Hospital da Senhora da Oliveira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pan-intestinal capsule endoscopy; PillCam Crohn's capsule protocol	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; Other Names: Conventional colonoscopy
Active Comparator: Conventional colonoscopy; Same-day colonoscopy under propofol sedation	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; Other Names: Conventional colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hospital da Senhora da Oliveira
• Collaborators: Medtronic
• Investigators: Principal Investigator: Bruno Rosa, MD, Gastroenterology Department, Hospital da Senhora da Oliveira - Guimarães, Portugal

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: iron deficiency anemia; gastrointestinal bleeding; pan-intestinal capsule endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Hematologic Diseases; Gastrointestinal Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Hemorrhage; Anemia; Gastrointestinal Hemorrhage; Deficiency Diseases; Iron Deficiencies
• Other Study ID Numbers: ERP-2020-12296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No