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

NCT04782986 | Completed DMC

• 1 other identifier: ERP-2020-12296
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia; GastroIntestinal Bleeding

Keywords

iron deficiency anemia; gastrointestinal bleeding; pan-intestinal capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  2 weeks

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

  2 weeks

Other Outcomes (3)

• Quality of bowel preparation at capsule endoscopy (small bowel)

  2 weeks

• Quality of bowel preparation at capsule endoscopy (colon)

  2 weeks

• Quality of bowel preparation at colonoscopy

  2 weeks

Study Arms (2)

Pan-intestinal capsule endoscopy

EXPERIMENTAL

PillCam Crohn's capsule protocol

Diagnostic Test: Pan-intestinal capsule endoscopy

Conventional colonoscopy

ACTIVE COMPARATOR

Same-day colonoscopy under propofol sedation

Diagnostic Test: Pan-intestinal capsule endoscopy

Interventions

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

Also known as: Conventional colonoscopy

Conventional colonoscopy; Pan-intestinal capsule endoscopy

Eligibility Criteria

• Age: 8 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidade Local de Saúde do Alto Ave, EPE: lead
• Medtronic: collaborator

Study Sites (1)

Gastroenterology Department, Hospital da Senhora da Oliveira

Guimarães, 4835-044, Portugal

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Gastrointestinal Hemorrhage

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bruno Rosa, MD

  Gastroenterology Department, Hospital da Senhora da Oliveira - Guimarães, Portugal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The capsule endoscopy reader will be independent from the physicians performing the conventional colonoscopies, and all investigators will be blinded to each other's findings and reports. Capsule endoscopy and colonoscopy findings will be compared and in case of disagreement it will be discussed until a consensus is reached, if necessary, with the intervention of an independent third reader, experienced in both techniques and not involved in the primary reading of any of the examinations.
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 4, 2021
• Study Start: June 19, 2020
• Primary Completion: September 20, 2022
• Study Completion: January 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)