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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

 The new ESD device: how it works (drawings). a “Needle” position: marking and incision. b Submucosal flushing and lifting. c “Needle” position for point-by-point submucosal dissection. d “Hook” position for submucosal dissection. e “Scythe” position for submucosal dissection. f The 4 different positions of the device.
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Related In: Results  -  Collection


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FI160-1:  The new ESD device: how it works (drawings). a “Needle” position: marking and incision. b Submucosal flushing and lifting. c “Needle” position for point-by-point submucosal dissection. d “Hook” position for submucosal dissection. e “Scythe” position for submucosal dissection. f The 4 different positions of the device.

Mentions: The device was designed in partnership with Medwork Medical Products and Services GmbH (Höchstadt an der Aisch, Germany) as a monopolar electrosurgical knife to be used by deploying the active wire out of the catheter sheath via a handle equipped with an electric connection port, as with most existing ESD knives. The major difference with this device is that the instrument can be used as a needle when only the very tip of the wire is deployed (2 mm in the current prototype) and also like a “scythe” when the wire is fully deployed. The needle position is typically suited to a peripheral incision, as with any other ESD device, whereas the “scythe” position offers a much longer electrical contact surface, which can make progression during the submucosal phase of the ESD procedure much easier and faster. In the “scythe” position, the 0.4-mm wire can be oriented easily over 360° by rotating the handle, so that the cutting plane remains always strictly parallel to the submucosal plane. When deployed halfway, the wire presents in the form of a hook, and can be used as such, to grab and cut fibers in the submucosa. Fig. 1 shows these different configurations.


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)

 The new ESD device: how it works (drawings). a “Needle” position: marking and incision. b Submucosal flushing and lifting. c “Needle” position for point-by-point submucosal dissection. d “Hook” position for submucosal dissection. e “Scythe” position for submucosal dissection. f The 4 different positions of the device.
© Copyright Policy
Related In: Results  -  Collection

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

FI160-1:  The new ESD device: how it works (drawings). a “Needle” position: marking and incision. b Submucosal flushing and lifting. c “Needle” position for point-by-point submucosal dissection. d “Hook” position for submucosal dissection. e “Scythe” position for submucosal dissection. f The 4 different positions of the device.
Mentions: The device was designed in partnership with Medwork Medical Products and Services GmbH (Höchstadt an der Aisch, Germany) as a monopolar electrosurgical knife to be used by deploying the active wire out of the catheter sheath via a handle equipped with an electric connection port, as with most existing ESD knives. The major difference with this device is that the instrument can be used as a needle when only the very tip of the wire is deployed (2 mm in the current prototype) and also like a “scythe” when the wire is fully deployed. The needle position is typically suited to a peripheral incision, as with any other ESD device, whereas the “scythe” position offers a much longer electrical contact surface, which can make progression during the submucosal phase of the ESD procedure much easier and faster. In the “scythe” position, the 0.4-mm wire can be oriented easily over 360° by rotating the handle, so that the cutting plane remains always strictly parallel to the submucosal plane. When deployed halfway, the wire presents in the form of a hook, and can be used as such, to grab and cut fibers in the submucosa. Fig. 1 shows these different configurations.

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