Endocuff Vision does not improve polyp detection rates when used by expert endoscopists

Liz Meszaros, MDLinx

Digestive Disease Week® (DDW)

San Diego, California, United States | May 21-24, 2016

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San Diego, CA, May 22, 2016—When performed by expert endoscopists, who are experienced and have acquired special accreditation, devices such as the Endocuff Vision may not improve polyp detection rates or adenoma detection rates (ADR), despite being shown to be safe and easy to use, according to researchers from the United Kingdom here at Digestive Disease Week 2016.

Take-home messages

  • When performed by expert, experienced endoscopist, who have acquired special accreditation, devices such as the Endocuff Vision may not improve polyp detection rates or adenoma detection rates.
  • These study results were negative, but the Endocuff was shown to be safe, with no adverse events, and easily used.

Pradeep Bhandari, MBBS, MD, MRCP, consulting gastroenterologist, professor of gastroenterology, Portsmouth Hospitals NHS Trust, Cosham, and University of Portsmouth, Portsmouth, United Kingdom, and colleagues conducted this, the first randomized, controlled trial of Endocuff Vision-assisted colonoscopy compared with standard colonoscopy for the detection of polyps in patients undergoing bowel cancer screening (the E-CAP Study).

“Endocuff Vision is a device that has been developed to improve the polyp detection rate,” explained Dr. Bhandari. “We know from the literature that endoscopists, when they do colonoscopies, they miss polyps. That can vary from 12% to 25%, depending on the size of the polyps,” he added.

They enrolled 531 patients between September 2014 and September 2015 for this single-center, parallel group, randomized, controlled trial. Patients were stratified based on whether they had presented for index screening colonoscopy or for polyp surveillance. Dr. Bhandari and fellow researchers then randomized patients within each of these groups to either standard colonoscopy or Endocuff-assisted colonoscopy. All procedures were performed by nationally accredited Bowel Cancer Screening Programme (BCSP) endoscopists who were experienced and had performed more than 5,000 colonoscopies, with cecal intubation rates of over 90%.

Researchers found no significant differences in the number of polys per patient, the primary endpoint of the study. Nor did they find any differences in the secondary endpoints of ADR, number of adenomas per patient, or polyp detection rate (see Table 1).

Table 1. E-CAP results

 

Standard

Endocuff

No. of participants

265

266

No. of polyps

470

436

Polyps per patient

1.77

1.63

Adenomas

364

343

Adenomas per patient

1.37

1.28

Polyp detection rate

185/265 (69.8%)

187/266 (70.3%)

Adenoma detection rate

167/265 (63%)

162/266 (60.9%)

Cancer detection rate

15/265 (5.7%)

14/266 (5.3%)

Dr. Bhandari and colleagues also evaluated these endpoints separately for the screening, group, surveillance group, and the four individual endoscopists, and also found no significant between-group differences. Finally, there were no adverse events, cecal intubation was not prolonged, and additional discomfort due to the Endocuff Vision was not reported.

“The primary results were very much against what we were expecting based on the previous data from these devices showing that it increased polyp detection rate. Unfortunately, we found that, in this particular group of patients having screening, and in expert endoscopists, this device doesn’t add anything extra because our baseline polyp detection rate was very high. Our control group showed a polyp detection rate of about 69% and an adenoma detection rate of around 63%. I don’t think there is much scope to go higher, and I think that that is one of the reasons why this device did not show any improvement in our study,” explained Dr. Bhandari.

In conclusion, he stated: “This is a very safe device, adds no adverse consequences, can be easily used, and it’s cheap. But, if you are an expert in your field, unfortunately, it doesn’t improve anything. It showed that if you are well-trained and expert in your field, these devices do not add anything extra.”

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