Capsule Endoscopy for Severe Hematochezia

NCT03616041 | Recruiting DMC FDA Device

• 1 other identifier: Colon Capsule
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with severe hematochezia (bright red blood per rectum) may have a bleeding source proximal to the colon. Visualization of the entire gastrointestinal tract using a second-generation colon capsule endoscopy system could improve diagnostic yields and form the basis for a new approach to early diagnosis that could change guidelines and practice management in these patients. The hypothesis of this study is that urgent colon capsule endoscopy will have higher rates of lesion localization and diagnosis and reduced time to diagnosis than the standard tagged red blood cell scanning and/or angiography. In this study, the eligible patients with severe hematochezia are enrolled to undergo an evaluation with the capsule endoscopy in addition to the standard tests including a tagged RBC scan and/or an angiogram. The outcomes in terms of diagnostic yields of the capsule endoscopy will be compared to the standard tests.

Conditions

Hematochezia

Keywords

Severe hematochezia

Outcome Measures

Primary Outcomes (1)

• The diagnostic yield tests in detecting a bleeding site and comparison of rates

  The diagnostic yield of the bleeding site detection (defined as the rates of detection and percentage of positive results as eg. positive test or total tests) for capsule endoscopy, tagged red blood cell scan/angiography, and endoscopy will be calculated. Rates of positive detection will be compared by the McNemar test for data using exact methods.

  30 days

Secondary Outcomes (3)

• The sensitivity for lesion localization

  30 days

• The specificity for lesion localization

  30 days

• The accuracy for lesion localization

  30 days

Study Arms (1)

Colon capsule endoscopy

Participant who meet the eligible criteria undergo an evaluation for severe hematochezia with a second-generation colon capsule endoscopy system in addition to standard diagnostic tests including tagged RBC scan, and/or computerized tomographic angiography (CTA), and/or conventional angiography.

Device: Second-generation colon capsule endoscopy system

Interventions

Second-generation colon capsule endoscopy system DEVICE

The PillCam (TM) Colon 2 which is a second-generation colon capsule endoscopy system, developed by Medtronic Inc. Colon capsule endoscopy, in contrast to current generation small bowel capsules, is capable of visualizing the entire lumen and mucosa from esophagus to rectum. This can be crucial for patients being screened or evaluated for colon disorders. This new generation of colon capsule endoscopy has a battery life of at least 10 hours and preserves energy using adaptive frame rate technology.

Colon capsule endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are hospitalized with severe GI bleeding (hematochezia) thought to be from a colonic or small bowel source, who meet entry criteria and lack exclusions.

You may qualify if:

• years old or older
• Able to provide written informed consent or have a legal surrogate who can provide written consent
• Presenting with evidence of severe ongoing hematochezia (i.e. passage of red blood or clots per rectum witnessed by a health care provider) and have a decrease in hemoglobin from baseline of 2 or more grams and/or transfusion of 1 or more units of red blood cells for resuscitation with either outpatient or inpatient start of severe hematochezia.

You may not qualify if:

• Uncooperative, unable to give written informed consent personally or through a legal surrogate, or refuse to participate
• Contraindication to undergo capsule endoscopy due to:
• Documented or suspected bowel obstruction (partial or complete)
• Anatomical GI abnormalities such as strictures of the foregut or small bowel
• Inability to swallow the capsule
• Presence of cardiac pacemakers or other implanted electromedical devices
• American Society of Anesthesiology (ASA) class V (very severe co-morbidities and very poor prognosis for surgery or similar procedures)
• Very severe GI bleeding with shock not responsive to IV fluid resuscitation and/or transfusions and IV medications to raise the systolic blood pressure
• History of recent hematemesis (within 30 days), positive nasogastric, or orogastric (OG) aspirate suggesting an upper GI bleed
• Presenting with recurrent hematochezia that has been previously diagnosed as anorectal bleeding

Sponsors & Collaborators

• CURE Digestive Diseases Research Center: lead

Study Sites (2)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Related Publications (12)

• Strate LL. Lower GI bleeding: epidemiology and diagnosis. Gastroenterol Clin North Am. 2005 Dec;34(4):643-64. doi: 10.1016/j.gtc.2005.08.007.

  PMID: 16303575 BACKGROUND

• Lanas A, Garcia-Rodriguez LA, Polo-Tomas M, Ponce M, Alonso-Abreu I, Perez-Aisa MA, Perez-Gisbert J, Bujanda L, Castro M, Munoz M, Rodrigo L, Calvet X, Del-Pino D, Garcia S. Time trends and impact of upper and lower gastrointestinal bleeding and perforation in clinical practice. Am J Gastroenterol. 2009 Jul;104(7):1633-41. doi: 10.1038/ajg.2009.164. Epub 2009 May 5.

  PMID: 19574968 BACKGROUND

• Camus M, Khungar V, Jensen DM, Ohning GV, Kovacs TO, Jutabha R, Ghassemi KA, Machicado GA, Dulai GS. Origin, Clinical Characteristics and 30-Day Outcomes of Severe Hematochezia in Cirrhotics and Non-cirrhotics. Dig Dis Sci. 2016 Sep;61(9):2732-40. doi: 10.1007/s10620-016-4198-y. Epub 2016 Jun 10.

  PMID: 27286877 BACKGROUND

• Zuckerman GR, Prakash C. Acute lower intestinal bleeding. Part II: etiology, therapy, and outcomes. Gastrointest Endosc. 1999 Feb;49(2):228-38. doi: 10.1016/s0016-5107(99)70491-8. No abstract available.

  PMID: 9925703 BACKGROUND

• Jensen DM, Machicado GA. Colonoscopy for diagnosis and treatment of severe lower gastrointestinal bleeding. Routine outcomes and cost analysis. Gastrointest Endosc Clin N Am. 1997 Jul;7(3):477-98.

  PMID: 9177148 BACKGROUND

• Jensen DM, Machicado GA, Jutabha R, Kovacs TO. Urgent colonoscopy for the diagnosis and treatment of severe diverticular hemorrhage. N Engl J Med. 2000 Jan 13;342(2):78-82. doi: 10.1056/NEJM200001133420202.

  PMID: 10631275 BACKGROUND

• Jensen DM, Ohning GV, Kovacs TO, Jutabha R, Ghassemi K, Dulai GS, Machicado GA. Natural history of definitive diverticular hemorrhage based on stigmata of recent hemorrhage and colonoscopic Doppler blood flow monitoring for risk stratification and definitive hemostasis. Gastrointest Endosc. 2016 Feb;83(2):416-23. doi: 10.1016/j.gie.2015.07.033. Epub 2015 Jul 31.

  PMID: 26227931 BACKGROUND

• Kanwal F, Dulai G, Jensen DM, Gralnek IM, Kovacs TO, Machicado GA, Jutabha R. Major stigmata of recent hemorrhage on rectal ulcers in patients with severe hematochezia: Endoscopic diagnosis, treatment, and outcomes. Gastrointest Endosc. 2003 Apr;57(4):462-8. doi: 10.1067/mge.2003.147.

  PMID: 12665754 BACKGROUND

• Jensen DM. Management of patients with severe hematochezia--with all current evidence available. Am J Gastroenterol. 2005 Nov;100(11):2403-6. doi: 10.1111/j.1572-0241.2005.00298.x.

  PMID: 16279892 BACKGROUND

• Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, Coron E, Gay G, Toth E, Riccioni ME, Carretero C, Charton JP, Van Gossum A, Wientjes CA, Sacher-Huvelin S, Delvaux M, Nemeth A, Petruzziello L, de Frias CP, Mayershofer R, Amininejad L, Dekker E, Galmiche JP, Frederic M, Johansson GW, Cesaro P, Costamagna G. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc. 2011 Sep;74(3):581-589.e1. doi: 10.1016/j.gie.2011.03.1125. Epub 2011 May 20.

  PMID: 21601200 BACKGROUND

• Boal Carvalho P, Rosa B, Dias de Castro F, Moreira MJ, Cotter J. PillCam COLON 2 in Crohn's disease: A new concept of pan-enteric mucosal healing assessment. World J Gastroenterol. 2015 Jun 21;21(23):7233-41. doi: 10.3748/wjg.v21.i23.7233.

  PMID: 26109810 BACKGROUND

• Camus M, Jensen DM, Ohning GV, et al. Urgent capsule endoscopy for bleeding site localization & lesion diagnosis of patients with severe hematochezia. Gastrointest Endosc 2013;77: AB274

  BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis M. Jensen, MD

  VA Greater Los Angeles Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 6, 2018
• Study Start: February 10, 2021
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

US (2)