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Iatrogenic colonic perforations: a threat turned into insignificance?
EDITORIAL
Iatrogenic colonic perforations: a threat turned into insignificance?
Because it usually requires surgical correction, perforation remains clinically relevant as one of the most fearsome complications of routine gastrointestinal endoscopy. Although there are some reports of successful closure with clips, which sometimes may work, a tool that can be used reliably and easily under such stressful situations and in a routine clinical setting is not yet available. In this issue of Gastrointestinal Endoscopy, Raju et al1 report the use of endoluminal suturing to overcome the limitations of clip closure of gapingly wide colon perforations. For smaller lesions the authors used a new prototype clipping system. Their investigation involved a well-conducted animal study that was rigorously performed. Their report is especially interesting because it provides sufficient information from autopsies and histologic studies to form a good base for future studies although it raises concerns regarding infection. The new clipping system used may offer some advantages to the currently available devices because it provides the possibility of using multiple clips without reloading and offers free rotation and repeat grasping (ie, relocation without having to fire a clip when in a nonoptimal position). Once larger and gaping perforations were attempted, however, even these new clips were not able to reliably close the defects. A potential solution was presented in this article by the use of a ‘‘tissue approximation device’’ (TAD), which enabled successful closure of all large defects produced.1 The use of this TAD device for closing gaping colonic perforations represents the near-to-final design at the end of a long road of development. As such, the basics of the system, a tag and thread device, is used for different purposes, among others in radiology for percutaneous gastrostomy and in GI endoscopy in the sewing machine for gastroplication. The tag and thread in combination with a long, flexible endoscopic needle as presented in the TAD device in this article was first used for tissue approximation and suturing in EUS.2 Change of use toward defect closure started when a reliable sewing method was needed in relation to the NOTES (natural orifice transluminal endoscopic surgery) procedures. Subsequent
tests had shown it to be a feasible method both for defect closure and for full-thickness resections.3 Meanwhile, the locking mechanism has been refined and a needle has been developed for exclusive use with this system so that an entire kit has emerged. The attempt to sew endoscopically and close defects is not new. Other methods simulating surgical sewing include the Eagle Claw (Olympus Optical, Tokyo, Japan), a curved needle system that is mounted onto the tip of an endoscope with a rigid distal part containing the needle and thread and opposable jaws that can be opened and closed by an outer handle to control the suturing.4 Despite some publications and repeated improvements up to Eagle Claw VII, it is still cumbersome for routine use, suggesting that it is some further steps away from being commercially available soon. A third full-thickness sewing device has recently been demonstrated (gProx, USGI
The ideal tissue approximation device should be easy to use with and within an average therapeutic endoscope by an average endoscopist occasionally, when the need arises.
Copyright ª 2007 by the American Society for Gastrointestinal Endoscopy 0016-5107/$32.00 doi:10.1016/j.gie.2006.10.023
Medical, San Clemente, Calif). It delivers expandable baskets, which serve as tissue anchors, while the tissue itself is captured with a cork-screw type retractor.5 In its present form this device needs a specific overtube to be used, which makes routine applicability more cumbersome. But the system appears to be only in its infancy and may become more promising with time. This brings us back to the device tested by these authors, which seems the closest to being brought to the market. Can it be easily used by every endoscopist? Let us give a moment’s thought to what may be the optimal and realistic requirements to such an endoscopic sewing device so that it might work reliably and easily enough even for the ‘‘everyman’’ (Morality, by Hugo von Hoffmansthal). An average endoscopist, not engaged in research, might want to use it only once or twice a year and he or she should then not need to be too concerned, as to ‘‘how’’ to set up and use it. The device then needs to be applicable through the accessory channel of the therapeutic endoscope without reducing its flexibility to the
912 GASTROINTESTINAL ENDOSCOPY Volume 65, No. 6 : 2007
www.giejournal.org
Fritscher-Ravens
Editorial
extent that retroflexion for repair in difficult locations is impossible. In short, it should be easy to use with and within an average therapeutic endoscope by an average endoscopist occasionally, when the need arises. This also implies that it should be applicable in an endoscopy suite, with no more than the assistants available for the routine procedures, not hinder the daily flow of work, and thereby not be too time consuming. Ideally then it should also be affordable so as to be kept in stock for the occasion that it is required. The article by Raju et al1 may provide answers to some of the questions raised above. Does the device work reliably and easily enough for the ‘‘everyman?’’ This question can certainly not be fully answered because only 4 animals were treated and larger studies are needed. However, it was technically feasible to close all large perforations with the TAD system with a leak-proof scar in autopsy after 2 weeks. This certainly represents a trend toward reliability. As to the ease of performance, the examiners were obviously inexperienced with the device when the study was started, but, as shown in their Table 1, after a very short learning curve the skills necessary improved rapidly. Although it took them 50 minutes to close the first hole, the time needed gradually and consistently decreased to 23 minutes at the fourth closure and it may be assumed that further reduction in time is realistic with more examinations performed. The entire device can be used through the working channel of a therapeutic endoscope and is manageable with one nurse assistant, who has to load the anchors into the needle and the threads into the locking catheter. A specific tool helps loading, but once a physician has come of age, he or she certainly should not forget or mislay his or her reading glasses. Thus, for this part of the proceduredreloadingdthere is certainly room for improvement because it should not be exclusively restricted to the ‘‘young eye.’’ Other than this, it would seem that, after 1 or 2 training sessions, an endoscopist should be able to use it comfortably. Although all lesions were closed without leakage, some abscesses were detected at autopsy. Infection, but also bleeding, must therefore continue to be a concern in relation to this as well as all other endoluminal sewing
devices. Obviously, larger-scale studies will be required to investigate these issues further. This article has provided us with some neat data on the new TAD system. It is a simple device that will make the learning curve shallow for the endoscopist and for the assisting nurse and it can be used for any perforation closure within the reach of an endoscope. This is certainly the single most important indication for the routine because it might solve an iatrogenic complication without the need of surgery and thereby reduce its threat. Thus, it might become a backup or a safety belt in the endoscopy suite. Those who are more scientifically interested may use it in connection with NOTES. When will it become commercially available? This only spiritual leaders and those who represent the industry may know. One would wish it to be soon..
www.giejournal.org
Volume 65, No. 6 : 2007 GASTROINTESTINAL ENDOSCOPY 913
DISCLOSURE The author holds patents with Ethicon Endosurgery. Annette Fritscher-Ravens, MD Department of Gastroenterology Homerton University Hospital London, United Kingdom
REFERENCES 1. Raju GS, Shibukawa G, Ahmed I, et al. Endoluminal suturing may overcome the limitations of clip closure of a gaping wide colon perforation (with videos). Gastrointest Endosc 2007;65:906-11. 2. Fritscher-Ravens A, Mosse CA, Mills TN, et al. A through the scope device for suturing and tissue approximation under endoscopic ultrasound control. Gastrointest Endosc 2002;56:737-42. 3. Ikeda K, Fritscher-Ravens A, Mosse CA, et al. Endoscopic full-thickness resection with sutured closure in a porcine model. Gastrointest Endosc 2005;62:122-9. 4. Hu B, Chung SC, Sun LC, et al. Endoscopic suturing without extracorporal knots: a laboratory study. Gastrointest Endosc 2005;62:230-3. 5. Mellinger JD, Macfadyen BV, Kozarek R, et al. Initial experience with a novel endoscopic device allowing intragastric manipulation and plication [abstract]. Gastrointest Endosc 2006;63:AB101.
Iatrogenic colonic perforations: a threat turned into insignificance?
Because it usually requires surgical correction, perforation remains clinically relevant as one of the most fearsome complications of routine gastrointestinal endoscopy. Although there are some reports of successful closure with clips, which sometimes may work, a tool that can be used reliably and easily under such stressful situations and in a routine clinical setting is not yet available. In this issue of Gastrointestinal Endoscopy, Raju et al1 report the use of endoluminal suturing to overcome the limitations of clip closure of gapingly wide colon perforations. For smaller lesions the authors used a new prototype clipping system. Their investigation involved a well-conducted animal study that was rigorously performed. Their report is especially interesting because it provides sufficient information from autopsies and histologic studies to form a good base for future studies although it raises concerns regarding infection. The new clipping system used may offer some advantages to the currently available devices because it provides the possibility of using multiple clips without reloading and offers free rotation and repeat grasping (ie, relocation without having to fire a clip when in a nonoptimal position). Once larger and gaping perforations were attempted, however, even these new clips were not able to reliably close the defects. A potential solution was presented in this article by the use of a ‘‘tissue approximation device’’ (TAD), which enabled successful closure of all large defects produced.1 The use of this TAD device for closing gaping colonic perforations represents the near-to-final design at the end of a long road of development. As such, the basics of the system, a tag and thread device, is used for different purposes, among others in radiology for percutaneous gastrostomy and in GI endoscopy in the sewing machine for gastroplication. The tag and thread in combination with a long, flexible endoscopic needle as presented in the TAD device in this article was first used for tissue approximation and suturing in EUS.2 Change of use toward defect closure started when a reliable sewing method was needed in relation to the NOTES (natural orifice transluminal endoscopic surgery) procedures. Subsequent
tests had shown it to be a feasible method both for defect closure and for full-thickness resections.3 Meanwhile, the locking mechanism has been refined and a needle has been developed for exclusive use with this system so that an entire kit has emerged. The attempt to sew endoscopically and close defects is not new. Other methods simulating surgical sewing include the Eagle Claw (Olympus Optical, Tokyo, Japan), a curved needle system that is mounted onto the tip of an endoscope with a rigid distal part containing the needle and thread and opposable jaws that can be opened and closed by an outer handle to control the suturing.4 Despite some publications and repeated improvements up to Eagle Claw VII, it is still cumbersome for routine use, suggesting that it is some further steps away from being commercially available soon. A third full-thickness sewing device has recently been demonstrated (gProx, USGI
The ideal tissue approximation device should be easy to use with and within an average therapeutic endoscope by an average endoscopist occasionally, when the need arises.
Copyright ª 2007 by the American Society for Gastrointestinal Endoscopy 0016-5107/$32.00 doi:10.1016/j.gie.2006.10.023
Medical, San Clemente, Calif). It delivers expandable baskets, which serve as tissue anchors, while the tissue itself is captured with a cork-screw type retractor.5 In its present form this device needs a specific overtube to be used, which makes routine applicability more cumbersome. But the system appears to be only in its infancy and may become more promising with time. This brings us back to the device tested by these authors, which seems the closest to being brought to the market. Can it be easily used by every endoscopist? Let us give a moment’s thought to what may be the optimal and realistic requirements to such an endoscopic sewing device so that it might work reliably and easily enough even for the ‘‘everyman’’ (Morality, by Hugo von Hoffmansthal). An average endoscopist, not engaged in research, might want to use it only once or twice a year and he or she should then not need to be too concerned, as to ‘‘how’’ to set up and use it. The device then needs to be applicable through the accessory channel of the therapeutic endoscope without reducing its flexibility to the
912 GASTROINTESTINAL ENDOSCOPY Volume 65, No. 6 : 2007
www.giejournal.org
Fritscher-Ravens
Editorial
extent that retroflexion for repair in difficult locations is impossible. In short, it should be easy to use with and within an average therapeutic endoscope by an average endoscopist occasionally, when the need arises. This also implies that it should be applicable in an endoscopy suite, with no more than the assistants available for the routine procedures, not hinder the daily flow of work, and thereby not be too time consuming. Ideally then it should also be affordable so as to be kept in stock for the occasion that it is required. The article by Raju et al1 may provide answers to some of the questions raised above. Does the device work reliably and easily enough for the ‘‘everyman?’’ This question can certainly not be fully answered because only 4 animals were treated and larger studies are needed. However, it was technically feasible to close all large perforations with the TAD system with a leak-proof scar in autopsy after 2 weeks. This certainly represents a trend toward reliability. As to the ease of performance, the examiners were obviously inexperienced with the device when the study was started, but, as shown in their Table 1, after a very short learning curve the skills necessary improved rapidly. Although it took them 50 minutes to close the first hole, the time needed gradually and consistently decreased to 23 minutes at the fourth closure and it may be assumed that further reduction in time is realistic with more examinations performed. The entire device can be used through the working channel of a therapeutic endoscope and is manageable with one nurse assistant, who has to load the anchors into the needle and the threads into the locking catheter. A specific tool helps loading, but once a physician has come of age, he or she certainly should not forget or mislay his or her reading glasses. Thus, for this part of the proceduredreloadingdthere is certainly room for improvement because it should not be exclusively restricted to the ‘‘young eye.’’ Other than this, it would seem that, after 1 or 2 training sessions, an endoscopist should be able to use it comfortably. Although all lesions were closed without leakage, some abscesses were detected at autopsy. Infection, but also bleeding, must therefore continue to be a concern in relation to this as well as all other endoluminal sewing
devices. Obviously, larger-scale studies will be required to investigate these issues further. This article has provided us with some neat data on the new TAD system. It is a simple device that will make the learning curve shallow for the endoscopist and for the assisting nurse and it can be used for any perforation closure within the reach of an endoscope. This is certainly the single most important indication for the routine because it might solve an iatrogenic complication without the need of surgery and thereby reduce its threat. Thus, it might become a backup or a safety belt in the endoscopy suite. Those who are more scientifically interested may use it in connection with NOTES. When will it become commercially available? This only spiritual leaders and those who represent the industry may know. One would wish it to be soon..
www.giejournal.org
Volume 65, No. 6 : 2007 GASTROINTESTINAL ENDOSCOPY 913
DISCLOSURE The author holds patents with Ethicon Endosurgery. Annette Fritscher-Ravens, MD Department of Gastroenterology Homerton University Hospital London, United Kingdom
REFERENCES 1. Raju GS, Shibukawa G, Ahmed I, et al. Endoluminal suturing may overcome the limitations of clip closure of a gaping wide colon perforation (with videos). Gastrointest Endosc 2007;65:906-11. 2. Fritscher-Ravens A, Mosse CA, Mills TN, et al. A through the scope device for suturing and tissue approximation under endoscopic ultrasound control. Gastrointest Endosc 2002;56:737-42. 3. Ikeda K, Fritscher-Ravens A, Mosse CA, et al. Endoscopic full-thickness resection with sutured closure in a porcine model. Gastrointest Endosc 2005;62:122-9. 4. Hu B, Chung SC, Sun LC, et al. Endoscopic suturing without extracorporal knots: a laboratory study. Gastrointest Endosc 2005;62:230-3. 5. Mellinger JD, Macfadyen BV, Kozarek R, et al. Initial experience with a novel endoscopic device allowing intragastric manipulation and plication [abstract]. Gastrointest Endosc 2006;63:AB101.