Capsule Endoscopy Versus Conservative Therapy for Obscure Gastrointestinal Bleeding

NCT01837030 | Withdrawn FDA Device

• 1 other identifier: Pro00023612
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single center prospective randomized control trial comparing the utility of performing capsule endoscopy compared to conservative management with oral iron therapy as the initial course of action in patients with non-severe obscure occult or obscure overt gastrointestinal (GI) bleeding. The investigators hypothesize that outcomes in patients with non-severe obscure GI bleeding who receive conservative therapy with oral iron will not differ to those on oral iron who undergo capsule endoscopy.

Conditions

Hemorrhage; Anemia

Outcome Measures

Primary Outcomes (1)

• Time to first blood transfusion after randomization

  Time-to-event analysis. Patients will be provided an index card on which they will record the date of their first blood transfusion after randomization

  12 month follow up period

Secondary Outcomes (5)

• Total number of blood transfusions

  3, 6, 9, and 12 months

• Total number of hospitalizations

  3, 6, 9, and 12 months

• Persistent Iron Deficiency Anemia as measured by ferritin and hemoglobin

  1, 3, 6, and 12 months

• Total number of bleeding-related procedures performed after randomization

  3, 6, 9, and 12 months

• Mortality

  3, 6, 9, and 12 months

Study Arms (2)

Oral Iron

OTHER

Dietary Supplement: Ferrous sulfate

Oral Iron and Capsule Endoscopy

OTHER

Dietary Supplement: Ferrous sulfate; Device: Capsule Endoscopy

Interventions

Ferrous sulfate DIETARY_SUPPLEMENT

Ferrous sulfate 325mg by mouth twice daily for the duration of the 12 month follow up period

Oral Iron; Oral Iron and Capsule Endoscopy

Capsule Endoscopy DEVICE

GIVEN capsule

Oral Iron and Capsule Endoscopy

Eligibility Criteria

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

You may qualify if:

• Adult men and post-menopausal women with iron deficiency anemia and pre-menopausal women with iron deficiency anemia and a negative gynecologic workup or adults with overt GI bleeding as defined by melena or hematochezia with a ≥2 gram drop in hemoglobin after stabilization (Iron deficiency is defined as hemoglobin \<13.7 g/dL in men and \<12 g/dL in women with serum ferritin level \<50 ng/mL). Also, patients with an otherwise unexplained drop in hemoglobin of ≥ 2 g/dL in the setting of hemoccult positive stool
• Negative EGD and colonoscopy for source of GI bleeding within six months of enrollment into the study.

You may not qualify if:

• Ongoing overt gastrointestinal bleeding requiring ≥4 units of packed RBC's on any given day in the setting of overt bleeding, blood transfusions on separate days (separated by ≥12 hours), or ≥6 units of packed RBC's over the previous 7-day period prior to presentation, in the setting of overt bleeding.
• Myocardial infarct, acute neurologic event, sepsis, or respiratory failure within the previous 1 week
• History of small bowel obstruction
• Pregnant women
• Prisoners
• Age less than 18
• Known GI or hematologic malignancy
• Achalasia
• Contraindications to capsule endoscopy (inability to take prep), or felt unsafe to undergo capsule as per study investigators
• Esophageal stricture that precludes even endoscopic capsule placement
• History of upper GI or small bowel surgery
• Inability to take oral iron.
• Active IV iron use.
• Alternate source of blood loss (e.g., menorrhagia)
• Hematemesis sufficient to be the cause of the hemoglobin decline

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (4)

• Goddard AF, James MW, McIntyre AS, Scott BB; British Society of Gastroenterology. Guidelines for the management of iron deficiency anaemia. Gut. 2011 Oct;60(10):1309-16. doi: 10.1136/gut.2010.228874. Epub 2011 May 11.

  PMID: 21561874 BACKGROUND

• Gordon S, Bensen S, Smith R. Long-term follow-up of older patients with iron deficiency anemia after a negative GI evaluation. Am J Gastroenterol. 1996 May;91(5):885-9.

  PMID: 8633576 BACKGROUND

• McLoughlin MT, Tham TC. Long-term follow-up of patients with iron deficiency anaemia after a negative gastrointestinal evaluation. Eur J Gastroenterol Hepatol. 2009 Aug;21(8):872-6. doi: 10.1097/MEG.0b013e328321836c.

  PMID: 19282769 BACKGROUND

• Laine L, Sahota A, Shah A. Does capsule endoscopy improve outcomes in obscure gastrointestinal bleeding? Randomized trial versus dedicated small bowel radiography. Gastroenterology. 2010 May;138(5):1673-1680.e1; quiz e11-2. doi: 10.1053/j.gastro.2010.01.047. Epub 2010 Feb 2.

  PMID: 20138043 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Anemia

Interventions

ferrous sulfate; Capsule Endoscopy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Andrew Brock, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 22, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

US (1)