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

Primary Purpose

Iron Deficiency Anemia, GastroIntestinal Bleeding

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pan-intestinal capsule endoscopy
Sponsored by
Hospital da Senhora da Oliveira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Iron Deficiency Anemia focused on measuring iron deficiency anemia, gastrointestinal bleeding, pan-intestinal capsule endoscopy

Eligibility Criteria

8 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gastroenterology Department, Hospital da Senhora da Oliveira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pan-intestinal capsule endoscopy

Conventional colonoscopy

Arm Description

PillCam Crohn's capsule protocol

Same-day colonoscopy under propofol sedation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 20, 2021
Last Updated
September 21, 2023
Sponsor
Hospital da Senhora da Oliveira
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT04782986
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital da Senhora da Oliveira
Collaborators
Medtronic

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, GastroIntestinal Bleeding
Keywords
iron deficiency anemia, gastrointestinal bleeding, pan-intestinal capsule endoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
Care ProviderInvestigator
Masking Description
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.
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pan-intestinal capsule endoscopy
Arm Type
Experimental
Arm Description
PillCam Crohn's capsule protocol
Arm Title
Conventional colonoscopy
Arm Type
Active Comparator
Arm Description
Same-day colonoscopy under propofol sedation
Intervention Type
Diagnostic Test
Intervention Name(s)
Pan-intestinal capsule endoscopy
Other Intervention Name(s)
Conventional colonoscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with at least one potentially bleeding lesion detected in small bowel and/or colon
Description
Potentially bleeding lesions include tumors, angiectasias, erosions, ulcers, diverticula or active bleeding
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Safety: number of participants with any procedure-related adverse events
Description
Adverse events include capsule retention, bowel preparation-related (nausea, vomiting, dizziness, seizures, abdominal pain or bloating), bleeding, perforation or cardiopulmonary complications
Time Frame
2 weeks
Title
Patient's preference: number of participants preferring capsule endoscopy or colonoscopy
Description
Questionnaire regarding preference based on overall experience and perception of the strengths and limitations of each procedure
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Quality of bowel preparation at capsule endoscopy (small bowel)
Description
Use of validated Brotz scale (4-grade qualitative assessment as excellent, good, fair or poor bowel preparation)
Time Frame
2 weeks
Title
Quality of bowel preparation at capsule endoscopy (colon)
Description
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
Time Frame
2 weeks
Title
Quality of bowel preparation at colonoscopy
Description
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)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Rosa, MD
Organizational Affiliation
Gastroenterology Department, Hospital da Senhora da Oliveira - Guimarães, Portugal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology Department, Hospital da Senhora da Oliveira
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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

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