The New American Guideline for Capsule Endoscopy – Too Much and Reaching Too Far?

Uwe Seitz, Heppenheim

Gastroenterology 2017; 152:497-514

Background and Aims

Video capsule endoscopy (CE) provides a noninvasive option to assess the small intestine, but its use with respect to endoscopic procedures and cross-sectional imaging varies widely. The aim of this consensus was to provide guidance on the appropriate use of CE in clinical practice.

Methods

A systematic literature search identified studies on the use of CE in patients with Crohn’s disease, celiac disease, gastrointestinal bleeding, and anemia. The quality of evidence and strength of recommendations were rated using the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach.

Results

The consensus includes 21 statements focused on the use of small-bowel CE and colon capsule endoscopy. CE was recommended for patients with suspected, known,
or relapsed Crohn’s disease when ileocolonoscopy and imaging studies were negative if it was imperative to know whether active Crohn’s disease was present in the small bowel. It was not recommended in patients with chronic abdominal pain or diarrhea, in whom there was no evidence of abnormal biomarkers typically associated with Crohn’s disease. CE was recommended to assess patients with celiac disease who have unexplained symptoms despite appropriate treatment, but not to make the diagnosis. In patients with overt gastrointestinal bleeding, and negative findings on esophagogastroduodenoscopy and colonoscopy, CE should be performed as soon as possible. CE was recommended only in selected patients with unexplained, mild, chronic irondeficiency anemia. CE was suggested for surveillance in patients with polyposis syndromes or other small-bowel cancers, who required small-bowel studies. Colon capsule endoscopy should not be substituted routinely for colonoscopy. Patients should be made aware of the potential risks of CE including a failed procedure, capsule retention, or a
missed lesion. Finally, standardized criteria for training and reporting in CE should be defined.

Conclusions

CE generally should be considered a complementary test in patients with gastrointestinal bleeding, Crohn’s disease, or celiac disease, who have had negative or inconclusive endoscopic or imaging studies.

What you should know

This guidelines on capsule endoscopy was put together by 7 Canadian experts and published in a high-ranking journal. It is limited to capsule endoscopy in adult patients and refers to the clinical and economic cicrumstances in North America.

There are 21 statements in the guideline, cited here as original text:

• Statement 1. In patients presenting with clinical features consistent with Crohn’s disease, and negative ileocolonoscopy and imaging studies, we recommend capsule endoscopy of the small bowel.
  GRADE: Strong recommendation, very low quality evidence. Vote: strongly agree, 83%; agree, 17%
• Statement 2. In patients with Crohn’s disease and clinical features unexplained by ileocolonoscopy or imaging studies, we recommend CE.
  GRADE: Strong recommendation, very low quality evidence. Vote: strongly agree, 100%.
• Statement 3. In patients with Crohn’s disease, when assessment of small-bowel mucosal healing (beyond the reach of ileocolonoscopy) is needed, we suggest CE.
  GRADE: Conditional recommendation, very low quality evidence. Vote: strongly agree, 33%; agree, 67%.
• Statement 4. In patients with a suspected small-bowel recurrence of Crohn’s disease after colectomy, undiagnosed by ileocolonoscopy or imaging studies, we recommend CE.
  GRADE: Strong recommendation, very low quality evidence. Vote: strongly agree, 100%.
• Statement 5. In patients with chronic abdominal pain or diarrhea as their only symptoms, and no evidence of biomarkers associated with Crohn’s disease, we suggest against the use of CE for the diagnosis of Crohn’s disease.
  GRADE: Conditional recommendation, low-quality evidence. Vote: strongly agree,67%; agree, 33%
• Statement 6. For patients with suspected celiac disease, we recommend against CE to make a diagnosis.
  GRADE: Strong recommendation, very low quality evidence for efficacy, low-quality evidence for safety. Vote: strongly agree, 100%.
• Statement 7. In patients with celiac disease and unexplained symptoms despite treatment and appropriate investigations, we recommend CE.
  GRADE: Strong recommendation, very low quality evidence for efficacy, low-quality evidence for safety. Vote: strongly agree, 83%; agree, 17%.
• Statement 8. In patients who have documented overt GI bleeding (excluding hematemesis) and negative findings on high-quality EGD and colonoscopy, we recommend CE as the next
  diagnostic step.
  GRADE: Strong recommendation, very low quality evidence. Vote: strongly agree, 100%.
• Statement 9. In patients with an overt, obscure bleeding episode, we recommend CE be performed as soon as possible.
  GRADE: Strong recommendation, very low quality evidence. Vote: strongly agree, 83%; agree, 17%.
• Statement 10. In patients with prior negative CE who have repeated obscure bleeding, we recommend repeated studies (endoscopy, colonoscopy, and/or CE).
  GRADE: Strong recommendation, very low quality evidence. Vote: strongly agree, 100%.
• Statement 11. In patients with suspected obscure GI bleeding and unexplained mild chronic iron-deficiency anemia, we recommend CE be used in selected cases.
  GRADE: Strong recommendation, low-quality evidence. Vote: strongly agree, 50%; agree, 50%.
• Statement 12. In patients with polyposis syndromes who require small-bowel studies, we suggest CE for ongoing surveillance.
  GRADE: Conditional recommendation, very low quality evidence for efficacy, low-quality evidence for safety. Vote: strongly agree, 50%; agree, 50%.
• Statement 13. We recommend against the routine substitution of colon CE for colonoscopy. GRADE: Strong recommendation, very low quality evidence. Vote: strongly agree, 83%; agree, 17%.
• Statement 14. In patients with inflammatory bowel disease (IBD), we recommend against substituting colon capsule for colonoscopy to assess the extent and severity of disease.
  GRADE: Strong recommendation, very low quality evidence for efficacy, low-quality evidence for safety. Vote: strongly agree, 100%.
  
• Statement 15. In patients undergoing CE, we recommend that the consent process include disclosure of the potential for a failed procedure, capsule retention, or a missed lesion. GRADE: Strong recommendation. Good practice statement, quality of evidence not assessed. Vote: strongly agree, 100%.
• Statement 16. In patients with known or suspected strictures of the small bowel, we suggest a patency capsule before CE to minimize risk of retention.
  GRADE: Conditional recommendation, very low quality evidence for efficacy, low-quality evidence for safety. Vote: strongly agree, 67%; agree, 33%.
  
• Statement 17. In patients with poor GI motility or chronic narcotic use, we recommend confirming that the capsule has reached the small bowel within 1 hour of capsule ingestion, and continuing the study to the full extent of the battery life of the capsule.
  GRADE: Strong recommendation, very low quality evidence. Vote: strongly agree, 83%; agree, 17%.
  
• Statement 18. In patients with a pacemaker, we suggest that CE can be performed without special precautions.
  GRADE: Conditional recommendation, very low quality evidence. Vote: strongly agree, 50%; agree, 50%.
  
• Statement 19. For patients undergoing CE, we recommend the use of a bowel preparation. GRADE: Strong recommendation, very low quality evidence for efficacy of prokinetics, low-quality evidence for efficacy of all other bowel preparations. Vote: strongly agree, 100%.
• Statement 20. In patients undergoing CE, we suggest that documentation have specific components noted on each report.
  GRADE: Conditional recommendation. Good practice statement, quality of evidence not assessed. Vote: strongly agree, 67%; agree, 33%.
  
• Statement 21. We recommend CE be performed by endoscopists with documented competency in the cognitive and technical aspects of conducting, reporting, and interpreting CE examinations.
  GRADE: Strong recommendation. Good practice statement, quality of evidence not assessed. Vote: strongly agree, 83%; agree, 17%.
  

All in all, it the low quality of the evidence as stated in the document is remarkable. In 14/18 statements (of the remaining 3 evidence was not analysed) the statements were assessed as based on „very low quality evidence“, hard to have a worse data basis than this. Nevertheless, the Canadian experts issue strong recommendations amd their agreement was very good. Why does nobody have the guts to speak out that the low evidence level does not allow for evidence-based recommendations ? The first 4 authors had an impressive list of company support (2 of those by a capsule company), the other 5 disclosed none of this.

For the main indication, mid-GI bleeding, only four statements were made. but 5 for Crohn´s disease. The statements could be considered liebral with regards to indications as compared with Europe or other areas in the world. Limitations can be due to clinical and also economic considerations. Whether such position papers with very limited evidence – but published in a high ranking journal – will help in daily practice, can be debated.