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

Sponsor

Hospital da Senhora da Oliveira (Other)

Overall Status

Recruiting

CT.gov ID

NCT04782986

Collaborator

Medtronic (Industry)

100

Enrollment

Location

Arms

28.4

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia GastroIntestinal Bleeding	Diagnostic Test: Pan-intestinal capsule endoscopy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Intervention 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.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:

Double (Care Provider, Investigator)

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.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 19, 2020

Anticipated Primary Completion Date :

Sep 20, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

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

Other Names:

Conventional colonoscopy

Outcome Measures

Primary Outcome Measures

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

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
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

Other Outcome Measures

Quality of bowel preparation at capsule endoscopy (small bowel) [2 weeks]
Use of validated Brotz scale (4-grade qualitative assessment as excellent, good, fair or poor bowel preparation)
Quality of bowel preparation at capsule endoscopy (colon) [2 weeks]
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
Quality of bowel preparation at colonoscopy [2 weeks]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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:

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