Evaluating ‘Early’ Video Capsule Endoscopy as a First-Line Diagnostic for GI Bleeding

endoscope and capsule endoscopy
Early video capsule endoscopy may be an appropriate means for frontline evaluation of gastrointestinal bleeding.

Each year, approximately 350,000 patients in the United States are admitted to the hospital for gastrointestinal bleeding, an event that continues to pose a unique set of challenges for clinicians, despite the frequency with which it is seen in the gastroenterological setting.1 The hospitalization rate for upper GI bleeding (UGIB) alone is 67 cases per 100,000 population in the Unites States; however, this number has decreased in recent years, falling from a previous high of 81 cases per 100,000 population.2 The “classic” diagnoses associated with UGIB such as gastritis and peptic ulcer disease (PUD) have similarly declined, while diagnoses such as Dieulafoy lesions, neoplasm, angiodysplasia, and esophagitis have increased.2  Although the all-cause inpatient mortality rate of UGIH decreased 28% from 2002 (2.6 per 100 cases) to 2012 (1.9 per 100 cases, P <0.01),GIB still represents a substantial healthcare burden, with annual costs of more than 1 billion dollars in the US.2,3 

Patients with UGIB can present with a multitude of symptoms including hematemesis, hematochezia, melena, and abdominal pain. These patients are typically started on high-dose intravenous proton pump inhibitors and subsequently evaluated. Many patients will eventually undergo evaluation with an upper endoscopy (EGD), but the timing of this procedure is variable and depends on multiple factors including hemoglobin, hemodynamic stability, and current polypharmacy (including antiplatelet and antithrombotic agents).

Timing is also critical, with patients shown to have better outcomes when properly resuscitated and stabilized prior to endoscopic procedure. For acute non-variceal upper GIB (NVUGIB), guidelines generally recommend EGD within 24 hours of admission; patients with VGIB are advised to undergo EGD within 12 hours of admission.4,5

Despite guideline support of these procedural time parameters, gastroenterologists often face delays due to patient, staff, and facility-related factors. In gastroenterology, a newer concept of increasing study is “early” video capsule endoscopy (EVCE) in the workup of GIB, which may support more expeditious patient evaluation, thereby allowing experts to sidestep such delays.1 Traditionally, when patients are evaluated for a GIB, they may undergo endoscopy, colonoscopy, or both based on their overall clinical presentation and the physician’s assessment of their lab results. VCE would typically be performed if a source of GIB could not be found on either the EGD or colonoscopy. 

EVCE is a unique first-line diagnostic approach to assessing GIB that aligns with the health care system’s current emphasis on value-based care and limitation of excess costs. It should also be noted that a noninvasive initial modality such as EVCE may be especially helpful during the COVID-19 pandemic, during which potential aerosolization and patient-health care staff exposure to should be minimized.  

Hakimian et al recently evaluated VCE as the first diagnostic modality in a population of hemodynamically stable patients with suspected GIB. Results from the single-center analysis were presented at the 2020 American College of Gastroenterology Annual Meeting.6 The investigators compared the study population, who underwent frontline VCE during the COVID-19 pandemic (March 2020-May 2020), with a historical control population comprising patients who completed evaluation for GIB via SOC in the pre-COVID era.

Results showed that there was no statistical difference between rates of bleeding localization on the first diagnostic test between groups (76% COVID era vs 63% pre-COVID era; P =.2); however, first-line VCE significantly decreased the number of patients who required invasive procedures (44% vs 96%; P <0.001). 

There were no significant differences in transfusion requirements, degree of hemoglobin drop, in-hospital mortality, re-admission rates, or re-bleeding rates between the 2 groups. Three patients in the COVID-19 group had capsule retention, but their outcomes were not reported at the medical meeting. Overall, data from Hakimian’s study indicate that EVCE can help minimize the number of invasive procedures performed, reduce unnecessary staff exposure to endoscopic aerosols, and preserve personal protective equipment (PPE).

It is important to contextualize Hakimian et al’s findings by reviewing GIB outcomes observed during the COVID-19 pandemic. Kim et al reviewed the impact of the COVID-19 outbreak on patient outcomes in individuals admitted with GIB in 2 New York City hospitals.7 The pre-COVID period was defined as February 1, 2020 to March 15, 2020 (n=123); the COVID pandemic period spanned March 16, 2020 to April 27, 2020 (n=88).

The pandemic period was associated with a longer length of hospital stay (5.5 days vs 4 days; P =.0043) and number of transfusions (1 unit vs 0 units; P =.0152), but a lower overall number of endoscopies performed (28.4% vs 50.4%; P =.001) compared with the pre-pandemic period. Although this study did not specifically mention VCE, the modality has likely been an underutilized diagnostic tool during the COVID-19 pandemic.

Considerations for EVCE Adoption

EVCE’s viability was also validated in a randomized controlled trial (ClinicalTrials.gov Identifier: NCT02442830) that compared EVCE with the standard of care (SOC) workup in patients admitted to the hospital with nonhematemesis GI bleeding (NHGIB).1 A total of 87 patients were included in the study, 42 of whom (48.3%) were randomly assigned to the EVCE arm. 

There were higher rates of bleeding localization in the EVCE arm compared with the SOC arm (64.3% vs 31.1%, P <0.01). This translated to a higher likelihood of endoscopic localization of bleeding over time with EVCE vs the SOC (adjusted [a] HR, 2.77; 95% CI, 1.36-5.64). 

Multivariate logistic regression showed that randomization to the VCE group was one of the few independent parameters associated with localization of bleeding by end of hospitalization (odds ratio [OR], 5.28; 95% CI, 1.74-16.06). Patients in the EVCE group were found to be more likely to have bleeding localized to the colon (aOR, 4.09; 95% CI, 1.12-15.00; P =.033), a diagnosis by end of admission (aOR, 2.67; 95% CI, 1.04-6.86; P =.041) and vascular lesion diagnosed as the source of bleeding (aOR, 10.73; 95% CI, 1.60-72.11; P =.015).   

The median time to first procedure was one of the key factors that contributed to the difference in localization rate between both cohorts. This value was 6 hours in the EVCE group compared with 21 hours in the SOC group (net difference of 15 hours). Importantly, there were no procedural adverse events (AEs) reported in either group. Variables such as bleeding descriptors (eg, melena vs hematochezia), which are frequently used to evaluate a patient for a potential procedure, were found to have poor predictive value for bleeding source localization.  

Unfortunately, the increased localization did not show statistically significantly differences in all-cause mortality or direct cost of hospitalization per patient. Although no significant cost differences were found, the authors postulated that “improved localization of bleeding may prevent or shorten future admissions, thereby lessening long-term costs for the health system and for the patient.”

When considering VCE in any part of a GIB algorithm, it is important to review the potential risks (eg, missed lesion or retention potentially requiring surgery or an endoscopic procedure).8 In addition, contraindications (both absolute and relative) need to be thoroughly reviewed, including dysphagia, delayed gastric emptying and/or decreased GI motility, history of stricture (esophageal, small bowel, colonic), and history of recent or recurrent small bowel obstructions. The VCE can be placed endoscopically into the small bowel if there are concerns regarding ingestion.

As VCE continues to be more frequently used in evaluations of patients with GIB, there are several other factors to consider, such as VCE manifestation. There are various different versions of VCE, including esophageal, small bowel, and colon capsules, and it will be interesting to see how these different versions may be incorporated into future research studies.

Further, insurance coverage for VCE also warrants consideration and may be challenging both on an outpatient and inpatient basis, especially if VCE is used as a first-line diagnostic, which may limit routine use in real-world settings. Broad adoption of EVCE may also be limited by the number of staff members trained to administer and read the capsule in a timely manner to expedite the GIB workup. Patients with GIB who are otherwise stable and waiting for their antiplatelet and/or antithrombotic agent to be cleared while it is held prior to an endoscopic procedure may represent a unique patient population for which EVCE might be advantageous.

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1.      Marya NB, Jawaid S, Foley A, et al. A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos). Gastrointest Endosc. 2019;89(1):33-43.e4. doi:10.1016/j.gie.2018.06.016

2.      Wuerth BA, Rockey DC. Changing epidemiology of upper gastrointestinal hemorrhage in the last decade: a nationwide analysis. Dig Dis Sci. 2018;63(5):1286-1293. doi:10.1007/s10620-017-4882-6

3.      Adam V, Barkun AN. Estimates of costs of hospital stay for variceal and nonvariceal upper gastrointestinal bleeding in the United States. Value Health. 2008;11(1):1-3. doi:10.1111/j.1524-4733.2007.00208.x

4.      Barkun AN, Almadi M, Kuipers E, et al. Management of nonvariceal upper gastrointestinal bleeding: guideline recommendations from the International Consensus Group. Ann Intern Med. 20193;171(11):805-22. doi:10.7326/M19-1795

5.      Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the Study of Liver Diseases. Hepatology. 2017;65(1):310-335. doi:10.1002/hep.28906

6.      Hakimian S, Hanscom M, Petersile M, Rau P, Foley A, Cave D. Video capsule endoscopy as first procedure for acute gastrointestinal bleeding: an approach to minimizing exposure to SARS-CoV-2 and conserving resources. Presented at: American College of Gastroenterology Annual Scientific Meeting; October 26-28, 2020. Abstract S0590.

7.      Kim J, Doyle JB, Blackett JW, May B, Hur C, Lebwohl B; HIRE study group. Effect of the COVID-19 pandemic on outcomes for patients admitted with gastrointestinal bleeding in New York City. Gastroenterology. 2020;159(3):1155-1157.e1. doi:10.1053/j.gastro.2020.05.031

8.      Enns RA, Hookey L, Armstrong D, et al. Clinical practice guidelines for the use of video capsule endoscopy. Gastroenterology. 2017;152(3):497-514. doi:10.1053/j.gastro.2016.12.032