Towards the future of endoluminal surgery – Pre-clinical experience of using the ESP.

S K Sharma¹, A Datta¹, A Nguyen¹, C D Dillon¹, L Lefebvre¹, G Silberhumer², J F Cornhill¹, J W Milsom¹. ¹Minimally Invasive New Technologies, Weill Cornell Medical College and N.Y Presbyterian Hospital, ²Medical University Vienna, Department of Surgery, Vienna, Austria

Objective:

Despite the widespread use of colonoscopy in the detection and prevention of colorectal cancer, technical challenges persist including lack of stability relative to the intestinal wall and poor intraluminal visibility. Additionally, broader adoption of intestinal endoluminal surgery (e.g. Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection and Combined Endo-laparoscopic Surgery) for diseases such as large benign polyps or early colorectal cancer remains delayed, in part due to these challenges, despite clear advantages over surgical segmental resection.

We present an innovative technology that addresses some of the major challenges of conventional colonoscopy and facilitates the advancement of surgical procedures into the endoluminal domain. We propose the design and use of a novel device, capable of being applied to a range of commercially available colonoscopes. Our hypothesis is that ESP significantly improves stability and visualization during colonoscopy.

Figure 1:

Description:

The disposable ESP integrates with existing colonoscopes, (figure 1) of varying diameters with no loss of function. ESP incorporates a double balloon system; the foreballoon may be extended beyond the colonoscope tip and inflated, it can then be deflated and redocked onto the colonoscope tip repeatedly, allowing use of the ESP throughout the colon. The aft balloon is positioned behind the articulating colonoscope segment providing stability. The ESP does not occupy the working channel, allowing therapeutic functionality to be maintained. It is intended that the ESP device be applied to all complex endoluminal procedures.

Preliminary results:

Our team designed, built and evaluated the prototype ESP in a bench-top setting on the Kyoto-Kagaku colonoscopic trainer. The silicone colon was marked with 1cm points allowing for calculation of surface area (see figure 2). Overall, there was significant improvement in colonoscope (Olympus PCF-180AL) stability (p<0.0001) and visualization (p<0.05) using ESP (see table 1). The foreballoon was deployed at multiple points along the ‘colon’ and successfully redocked in 100% of attempts during the evaluation. Colonoscope functionality was preserved in its entirety whilst using ESP.

Figure 2:

Table 1:

Variable	Colonoscope	Colonoscope + ESP (* = p< 0.05)
Intubated Caecum (%)	100	100
Time to reach caecum (sec)	38.2	47.6*
Colonoscope Migration following 5cm longitudinal traction (cm)	60	0*
Surface Area Visualized (cm2)	34.6 (straight) 39 (flexure)	50 (both)*
Time for maximum visualization (sec)	35 (straight) 57 (flexure)	19.6 (straight)* 35 (flexure)*
Damage to colon	No	No

Conclusions:

To the best of our knowledge, the ESP demonstrates the first platform capable of repetetive endoluminal balloon deployment whilst preserving colonoscope functionality. Preliminary results indicate significant enhancements of visualization and stability. Further in-vivo feasibility testing is needed to quantify the therapeutic benefits of ESP. Whilst additional development and testing is necessary, the ESP shows promise in expanding both the current and future surgical applications of colonoscopy.

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