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A new device to expedite endoscopic submucosal dissection procedures: a randomized animal study of efficacy and safety (with videos).

Leblanc S, Barret M, Brehm A, Rouquette A, Camus M, Wintermantel E, Prat F - Endosc Int Open (2015)

Bottom Line: Primary judgment criterion was safety of procedures.A comparison of time-consumption between groups did not show statistically significant differences, but a dramatic reduction of procedure duration was observed in some procedures with the new device; based on observed data, a potential time-saving of up to 66 % was anticipated, with a relatively short learning curve.This new versatile device proved to be as safe as regular ESD knives, and seems likely to help reduce the duration of the procedure.

View Article: PubMed Central - PubMed

Affiliation: Gastroenterology Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Paris, France.

ABSTRACT

Background and study aims: Endoscopic submucosal dissection (ESD) is a recognized method for the curative treatment of superficial neoplasia, but its use is limited by lengthy procedures and the lack of versatility of existing knives. We developed a prototype ESD device with the ability to work as a needle, hook, or "scythe." This new device was compared to regular ESD knives in a randomized animal study.

Patients and methods: Eight pigs underwent two gastric ESD procedures each, similar in size and difficulty, one with a regular ESD device and the other with the new device. The order and location of each ESD, as well as the performing operator, were randomized. Primary judgment criterion was safety of procedures. Overall and submucosal dissection procedure times were measured. Time-to-surface ratios were measured and estimated for ESDs larger than those performed. Histopathology of the resected tissue and remaining stomach was done after each experiment.

Results: No complications were observed throughout the study and all resections were completed en-bloc and uneventfully. The submucosal extension of resections was similar with both the standard and the new devices. A comparison of time-consumption between groups did not show statistically significant differences, but a dramatic reduction of procedure duration was observed in some procedures with the new device; based on observed data, a potential time-saving of up to 66 % was anticipated, with a relatively short learning curve.

Conclusions: This new versatile device proved to be as safe as regular ESD knives, and seems likely to help reduce the duration of the procedure.

No MeSH data available.


Related in: MedlinePlus

 Time/surface ratio for completing and ESD with the standard ESD knife vs the new device. a Overall results in all animals. b Results for the submucosal phase of ESD in the second series of 4 pigs.
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FI160-4:  Time/surface ratio for completing and ESD with the standard ESD knife vs the new device. a Overall results in all animals. b Results for the submucosal phase of ESD in the second series of 4 pigs.

Mentions: No significant differences in time needed to complete the procedures were observed between procedures with the new devices vs the regular one (mean ESD time of 29.6 ± 11.56 minutes for the new device vs 35.5 ± 7.95 minutes for the regular one, P = 0.11), but that was as expected, given the small numbers of animals involved and procedures performed. However, overall procedure times were never longer with the new device than with the regular one; on the contrary, procedure time with the new device was dramatically shorter in several procedures ( Table 1). Findings were the same when overall ESD procedure time was calculated as a fraction of the lesion area, approximated as a disc with a trend to shorter procedures with the new device (a mean of 3.80 min/cm² for the new device vs 4.33 min/cm² for the regular one), but not statistically different (P = 0.22). Some procedures were remarkably shorter with the new device, particularly in the latest experiments (Fig. 4 a). In addition, when the submucosal phase of the dissection was taken into account separately, as was done with the last four animals, the same trend was observed, with two experiments showing no or only a little time saving, and the other two exhibiting a remarkable fall in sub-procedure time (Fig. 4 b). Finally, a simulation of the potential time saving as a function of the lesion area, based on observed minimum and maximum procedure time/area ratios with both devices, showed that the new device could save up to 66 % of the procedure time when comparing minimum time/area ratios for both devices (Fig. 5).


A new device to expedite endoscopic submucosal dissection procedures: a randomized animal study of efficacy and safety (with videos).

Leblanc S, Barret M, Brehm A, Rouquette A, Camus M, Wintermantel E, Prat F - Endosc Int Open (2015)

 Time/surface ratio for completing and ESD with the standard ESD knife vs the new device. a Overall results in all animals. b Results for the submucosal phase of ESD in the second series of 4 pigs.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4612242&req=5

FI160-4:  Time/surface ratio for completing and ESD with the standard ESD knife vs the new device. a Overall results in all animals. b Results for the submucosal phase of ESD in the second series of 4 pigs.
Mentions: No significant differences in time needed to complete the procedures were observed between procedures with the new devices vs the regular one (mean ESD time of 29.6 ± 11.56 minutes for the new device vs 35.5 ± 7.95 minutes for the regular one, P = 0.11), but that was as expected, given the small numbers of animals involved and procedures performed. However, overall procedure times were never longer with the new device than with the regular one; on the contrary, procedure time with the new device was dramatically shorter in several procedures ( Table 1). Findings were the same when overall ESD procedure time was calculated as a fraction of the lesion area, approximated as a disc with a trend to shorter procedures with the new device (a mean of 3.80 min/cm² for the new device vs 4.33 min/cm² for the regular one), but not statistically different (P = 0.22). Some procedures were remarkably shorter with the new device, particularly in the latest experiments (Fig. 4 a). In addition, when the submucosal phase of the dissection was taken into account separately, as was done with the last four animals, the same trend was observed, with two experiments showing no or only a little time saving, and the other two exhibiting a remarkable fall in sub-procedure time (Fig. 4 b). Finally, a simulation of the potential time saving as a function of the lesion area, based on observed minimum and maximum procedure time/area ratios with both devices, showed that the new device could save up to 66 % of the procedure time when comparing minimum time/area ratios for both devices (Fig. 5).

Bottom Line: Primary judgment criterion was safety of procedures.A comparison of time-consumption between groups did not show statistically significant differences, but a dramatic reduction of procedure duration was observed in some procedures with the new device; based on observed data, a potential time-saving of up to 66 % was anticipated, with a relatively short learning curve.This new versatile device proved to be as safe as regular ESD knives, and seems likely to help reduce the duration of the procedure.

View Article: PubMed Central - PubMed

Affiliation: Gastroenterology Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Paris, France.

ABSTRACT

Background and study aims: Endoscopic submucosal dissection (ESD) is a recognized method for the curative treatment of superficial neoplasia, but its use is limited by lengthy procedures and the lack of versatility of existing knives. We developed a prototype ESD device with the ability to work as a needle, hook, or "scythe." This new device was compared to regular ESD knives in a randomized animal study.

Patients and methods: Eight pigs underwent two gastric ESD procedures each, similar in size and difficulty, one with a regular ESD device and the other with the new device. The order and location of each ESD, as well as the performing operator, were randomized. Primary judgment criterion was safety of procedures. Overall and submucosal dissection procedure times were measured. Time-to-surface ratios were measured and estimated for ESDs larger than those performed. Histopathology of the resected tissue and remaining stomach was done after each experiment.

Results: No complications were observed throughout the study and all resections were completed en-bloc and uneventfully. The submucosal extension of resections was similar with both the standard and the new devices. A comparison of time-consumption between groups did not show statistically significant differences, but a dramatic reduction of procedure duration was observed in some procedures with the new device; based on observed data, a potential time-saving of up to 66 % was anticipated, with a relatively short learning curve.

Conclusions: This new versatile device proved to be as safe as regular ESD knives, and seems likely to help reduce the duration of the procedure.

No MeSH data available.


Related in: MedlinePlus