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SECTION 1 Development of the NOTES Concept
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secure. A group from the University of Washington described an experimentally reliable method for gastrotomy closure using available clips and detachable endoscopic ligation loops [27]. This retracted clip -assisted loop closure tech­nique is performed by tying long sutures to standard endo­scopic clips. An endoscopic balloon, advanced through the gastrotomy and infl ated extramurally, is used to invert the serosa into the gastric lumen and allow several clips to be placed on the serosa around the margin of the viscotomy. Using a double -channel endoscope, the ends of the sutures were pulled through an open endoloop and out the biopsy channel of the scope. While applying tension on the sutures, the endoloop is cinched, which securely closes the gastrot­omy in a full -thickness fashion. A similar procedure, called the Queen ′s closure, described a procedure using PolyLoop ligation devices clipped to the margins of the enterotomy. Experimental results found suffi cient closure and leak pres­sures; however, the procedure took relatively long (mean closure time: 1.2 hours) [28].
Very limited data are available on the use of an omental pedicle pulled into the gastrotomy and fi xed to the gastric wall by endoscopic clips [29]. Although certainly cheap, several serious infectious complications were observed during necropsy with their survival animal model. This method also creates otherwise avoidable adhesions on purpose.
Clips are often successfully used to close iatrogenic colon perforations. Mathews et al. looked at both endoclips and endoloops to close intentional colotomies for NOTES [30]. For their study, the colon was cleaned with sterile enemas, antibiotics, and betadine. Transcolonic peritoneoscopies were performed and endoloops were the primary attempted closure technique. In case of inadequate closure additional endoclips were used. In one animal pure endoclip colon closure was performed. After seven days the evaluation at
necropsy demonstrated normally healing serosa in all but one endoloop closure. Interestingly, the pure endoscopic clip closure did not achieve microscopic continuity of granula­tion tissue.
Full-thickness closure clips
The inadequacy of current hemostatic endoclips for robust NOTES closures stimulated development of a new genera­tion of full -thickness over -the-scope clips – good for both hemostasis and enteric closures. The fi rst over -the-scope clip system to reach the market is called OTSC (Ovesco GmbH, Tübingen, Germany). This clip is made of nitinol (an elastic alloy) and imitates the U shape of a bear trap (Figure 6.3). The system consists of a plastic cap together with the mounted nitinol clip, which is attached to the tip of a fl exible endoscope. A trigger thread is brought through the biopsy channel and mounted to a wheel -handle mounted on the scope handle. The edges of the enterotomy are grasped with a double -action grasper and retracted into the scope cap and the rigger -wheel turned to fi re the clip (Video 6.6). Several studies have already shown successful closure of transgastric defects with favorable burst pressures [31,32]. The OTSC is on the market in Europe and the USA; however, it has not been reportedly used for a clinical NOTES access closure.
A similar concept but differently shaped clip -device is the
Padlock-G® deployed by the Lock -It® system (Aponos Medical, Kingston, NH, USA). Due to its more pliable mate­rial and fl at profi le, it has been shown to be removable after potential misplacement [33], which might be a benefi cial feature. Suffi cient burst pressure resistance after gastrotomy closure has been demonstrated in an ex vivo study [34] as well as in survival animal studies [35]. However this device is not clinically available yet (Figure 6.4).
Figure 6.3 The Ovesco clip in place (commercially available USA and EU).
62
Figure 6.4 The Aponos over -the-scope closure clip (not commercially
available).
Figure 6.5 The Ethicon TAS T -bar fastener system (available for research
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only).
T-fastener closures
CHAPTER 6 NOTES Closure Techniques
Figure 6.6 The Cook loop -fastener closure system (not commercially
available).
A T -fastener endoscopic suturing system with threads attached and delivered through an EUS needle, was an early method to close enterotomies. In 2007 it was successfully used for the closure of the esophageal access into the medi­astinum in an animal survival model [36]. A T -bar system was recently also clinically used for the closure of a postop­erative anastomotic esophageal leak [37]. The Tissue Appo­sition System (TAS, Ethicon Endo -Surgery Inc., Cincinnati, Ohio, USA) is a commercialized version of a T -fastener system. Initially proposed in 2003, the TAS includes a deliv­ery needle, the T -bar/suture combination, and a suture locking or cinching device (Figure 6.5). The system uses a fl exible hollow needle to deliver a threaded T -tag through tissue via a 2.8 mm channel of the endoscope. The length of the needle can be adjusted, which allows deploying the T-tags in a variety of gastrointestinal tissue. A series of paired tags can be endoscopically positioned transmurally around an enteric defect. The two suture tails are then threaded into and through a plastic cinching plug attached to a fl exible pushrod. The TAS device, available only on a restricted basis, has already been used with some success in several control­led human studies [38–41] (Video 6.7). Several investiga­tors, however, have found inadvertent and potentially dangerous penetration of adjacent organs during the blind placement of transmural T -tag sutures.
Similar T -bar systems (Wilson -Cook Medical, Winston ­Salem, NC, USA; Bard Medical Division, Covington, GA; Olympus, Tokyo, Japan) have been reported to provide reli­able closures of an experimental NOTES gastrotomy in
animals. The Cook system is a series of T -fastners looped along a continuous suture.
The Baystate Medical Center group has described a “loop-
anchor purse -string closure technique in a porcine model using the Cook system [42]. The technique consisted of transmurally placing four such loop -anchors in a square pattern around the enterotomy. A monofi lament suture loop is pre -attached to the loops of the fasteners. After the viscotomy had been performed, simple cinching of the suture with a push -rod catheter and securing it with a press ­fi t metal collar was used for closure. Early success of this technique was reported in an animal study (Figure 6.6). The T-tag system has also been successfully used for colotomy closure [43].
Flexible endoscopic suturing devices and systems
The need for an endoscopic closure that approximates the security of the “gold-standard” suture or staple techniques is a primary concern of NOTES. This has led to an intense effort on the part of industry to develop new endoscopic suturing devices. This is particularly important and challeng­ing for transgastric surgery, which remains a highly demand­ing intervention [44–46].
One of the fi rst clinically available fl exible endoscopic
suturing systems for full -thickness closure of an intentional
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(a)
(b)
Figure 6.7 The g -Prox by USGI Medical. (a) The device as a large grasper. (b) Once closed, the deployment needle transfi xes the tissue to deploy the suture (available US and EU).
gastrotomy was the g -Prox™ (USGI Medical, San Clemente, CA, USA) (Figure 6.7). This 5 mm fl exible grasper can be loaded with a hollow catheter, preloaded with expandable polyester tissue baskets/anchors (g -Cath™, USGI Medical). Together with the use of a helical grasper (g -Lix™, USGI Medical), the full thickness of the viscera can be pulled into the jaws of the device, allowing full -thickness sutures to be taken. Once the tissue is grasped, the hollow g -Cath needle is deployed perpendicularly through the double layers of tissue (mucosa, muscle, serosa; serosa, muscle, mucosa). As the needle tip ends up within the lumen of the organ, the anchors can be deployed under direct visualization. The needle is then pulled back and a second basket, connected to the distal anchor, can be released on the other edge of the wound. Both baskets can then be cinched together with
Figure 6.8 The USGI TransPort scope needed to utilize the g -Prox suturing device (available US and EU).
a one -way mechanism that securely approximates the tissue (Video 6.8). The size of this device requires a complete set of access instrumentation. This endoscopic delivery platform (TransPort, USGI Medical) is 18 mm in diameter, has four large channels, one of which is a 5 mm channel for a small, fl exible upper endoscope for visualization, as well as a “rid­gidizing” or “shape-lock function ” to maintain positioning [46] (Figure 6.8). This novel fl exible instrumentation plat­form was used for the performance of the fi rst transgastric cholecystectomy in humans in 2007 [44]. The NDO Plicator (NDO Surgical, Mansfi eld, MA, USA) represented another endoscopic suturing instrument, which was initially devel­oped and used for the treatment of gastroesophageal refl ux disease. This fl exible endoscopic tissue plicator consisted of two jaws with a retractable corkscrew tissue grasper, and accommodated an endoscope, which could be passed through a channel. The jaws incorporated preloaded ePTFE ­pledget suture implants with attached titanium anchors, which allowed secure U -stitches (Figure 6.9). Animal studies have shown the feasibility of full -thickness NOTES gastrot­omy closure [47]. However, today the device is no longer clinically available.
Also not available for widespread clinical use is another endoscopic suturing prototype (LSI Solutions, New York, NY, USA). It represents an automated device able to suction enteric wall tissue into a small chamber, where a 2.5 cm linear incision and purse string suture can be created with one application. After using the enterotomy, the purse string suture is cinched with an additional titanium knot -cinching device. An ex vivo animal study was able to demonstrate quick and reliable gastric closure within a small number of experiments [48] (Figure 6.10). The same group had also evaluated the endoscopic suturing prototype (LSI) for colon access closure and compared the results with endoloops and
64
Figure 6.9 The NDO endolumenal suturing device (no longer available).
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CHAPTER 6 NOTES Closure Techniques
Figure 6.10 The LSI one -step purse string/enterotomy prototype device.
endoscopic clips [49]. Closure with the prototype device and the endoloops were both found to achieve the inversion of tissue, which was hypothesized to provide suffi cient closure.
A true endoscopic suturing device that does not require a specialized delivery device is the OverStitch ™ Endoscopic Suturing System (Apollo Endosurgery, Austin, TX, USA). Developed by the Apollo Group with Olympus and called the “Eagle Claw ” (Olympus Medical Systems, Tokyo, Japan), it was initially designed to imitate the surgical oversewing of bleeding gastric ulcers but was quickly adopted and evalu­ated for full -thickness tissue closure of a transgastric NOTES access [50,51]. The OverStitch device is attached to the tip of a double -channel endoscope and has a large curved needle with which a full -thickness suture can be placed and later cinched (Figure 6.11). When it was tested in a survival animal model, full -thickness healing of all gastrotomies, with no evidence of leakage, was observed after two weeks.
Figure 6.11 The Apollo Endosurgery OverStitch device (available US and EU).
An average of three sutures was used for closure of the gastrotomy. Although not yet reportedly used for the closure of a NOTES access, its clinical versatility, including the closure of an iatrogenic gastrotomy, has already been described [52] (Video 6.9). Although further evaluation still appears to be mandatory, this novel tool represents the fi rst endoscopic suturing device directly mimicking surgical suturing of gastrointestinal tissue.
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Figure 6.12 The Covidien fl exible Endo Stitch prototype device (available for research only).
A fl exible equivalent of the laparoscopic suturing device, the Endo Stitch (Covidien, North Haven, CT, USA) has been recently described and provided excellent burst pressure results in an ex vivo model for gastric defect closure [53]. This fl exible tool uses the well -known technical principle of a thread attached to a needle, which is alternatively shuttled between the two instrument jaws (Figure 6.12). However, the endoscopic device has not yet been released.
Stapling devices
In open and laparoscopic surgery, staplers are a method for gastrointestinal anastomosis or closure that are as accepted as(and more widely used than) suturing. Using an incorpo­rated power unit, a fl exible endoscopic linear stapler with a 60 cm long working shaft (Natural Orifi ce Linear Cutter, Power Medical Interventions) was clinically available several years ago and might be back on the market in the near future (Figure 6.13). Although technical diffi culties with deployment and maneuvering of the stapler have been reported, this technology represents an important step in the future development of NOTES [54]. Several preclinical studies have shown favorable results and secure closures. Within an ex vivo comparison with several other closure modalities, it was, in fact, found to have the highest air leak pressure resistance [8]. As, additionally, this device has already been successfully used for full -thickness gastric resection in the stomach in a clinical setting [55], a potential feasibility for NOTES closure appears to be possible. More recently, the use of circular EEA hemorrhoid and prolapse staplers has been described for the closure of a rectal vis­cerotomy after a NOTES segmental colectomy [56].
Figure 6.13 The fl exible linear cutter stapler by Power Medical (no longer commercially available).
Figure 6.14 The off label use of currently available percutaneus cardiac septal occluder devices has been described in animal work.
Other closure concepts
A completely different technical approach with an already available cardiac septal defect occluder device (Nitinol Septal Occluder, Occlutech, Helsingborg, Sweden) has been evalu­ated by the IRCAD group in Strasbourg [57]. This occluder device was developed to close cardiac artrial and ventricular septal defects angiographically. It consists of a self -expandable double umbrella -shaped nitinol wire mesh, which is linked together by a short connecting -waist (Figure 6.14). Addi­tionally, the umbrellas are fi lled with a non -permeable poly­ethylene terephthalate patch. Due to the nitinol ’s elastic properties, the device can be loaded inside a hollow catheter
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CHAPTER 6 NOTES Closure Techniques
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and the two umbrella shaped meshes can be deployed sepa­rately, the fi rst outside the enterotomy and the second inside. The elastic nitinol wire frames have diameters of 23 mm and 25 mm and give suffi cient transmural closure force. In a 12 -week porcine survival study, it was found that full-thickness gastrotomies could be successfully closed with no related complications. Although it provides an appealing and easy concept of NOTES access closure, the barriers to its widespread adoption are its non -absorbability and extremely high cost.
Tissue glue has been successfully used to close enterocu­taneous fi stulas, but has been reportedly used only once for transgastric closure and might have unreliable closure strength.
Conclusion
The majority of currently performed clinical NOTES cases have been hybrid, or laparoscopic -assisted, procedures. This has been due to safety reasons and to simultaneously ensure appropriate closure of the individual NOTES access. To pursue pure NOTES, closure techniques have to be reliable and simple to accomplish. As described throughout this chapter, extensive developmental work has been done within the past few years to accomplish this important requirement. Safe NOTES closure in humans has been dem­onstrated. The clinical availability of many novel suturing and closure devices can be expected to further facilitate NOTES and will also enable more advanced intralumenal endoscopy and endoscopic surgery. Despite still existing unmet technical needs in natural orifi ce surgery, NOTES closure techniques have been addressed extensively and appear to be increasingly reliable and easier to accomplish.
Chapter video clips
Video 6.1 Esophageal submucosal fl ap. Video 6.2 Transrectal/transanal delivery of sigmoid colon. Video 6.3 Transanal endoscopic microsurgery (TEM) suture
closure.
Video 6.4 NOTES colorectal anastomosis (colotomy closure). Video 6.5 Endoclips closure of esophageal mucosa. Video 6.6 Over -the-scope clip (OTSC ®). Video 6.7 Tissue apposition system (TAS ®) closure. Video 6.8 NOTES gastrotomy closure with the g -Prox. Video 6.9 OverStitch closure of gastric perforation.
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22 Gavagan JA, Whiteford MH, Swanstrom LL. Full-thickness
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23 Whiteford MH, Denk PM, Swanstrom LL. Feasibility of radical
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26 Rieder E, Spaun GO, Khajanchee YS, et al. A natural orifi ce
transrectal approach for oncologic resection of the rectosigmoid: an experimental study and comparison with conventional lapar­oscopy . Surg Endosc 2011;25(10):3357–63.
27 Lee SS, Oelschlager BK, Wright AS, et al. Assessment of a simple,
novel endoluminal method for gastrotomy closure in NOTES . Surg Endosc 2011;25(10):3448–52.
28 Hookey LC, Khokhotva V, Bielawska B, et al. The Queen ’s
closure: a novel technique for closure of endoscopic gastrotomy for natural -orifi ce transluminal endoscopic surgery . Endoscopy 2009;41:149–53.
29 Dray X, Giday SA, Buscaglia JM, et al. Omentoplasty for gas-
trotomy closure after natural orifi ce transluminal endoscopic surgery procedures (with video) . Gastrointest Endosc 2009;70: 131–40.
30 Mathews JC, Chin MS, Fernandez-Esparrach G, et al. Early
healing of transcolonic and transgastric natural orifi ce translu­minal endoscopic surgery access sites . J Am Coll Surg 2010;210:480–90.
31 Voermans RP , van Berge Henegouwen MI, Bemelman WA ,
Fockens P. Novel over -the-scope-clip system for gastrotomy closure in natural orifi ce transluminal endoscopic surgery (NOTES): an ex vivo comparison study . Endoscopy 2009;41: 1052–5.
32 von Renteln D, Vassiliou MC, Rothstein RI. Randomized con-
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33 von Renteln D, Vassiliou MC, Rothstein RI. Endoscopic removal
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34 Romanelli JR, Desilets DJ, Earle DB. Natural orifi ce transluminal
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35 Desilets DJ, Romanelli JR, Earle DB, Chapman CN. Gastrotomy
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37 Hampe J, Schniewind B, Both M, Fritscher -Ravens A. Use of a
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40 Austin RC, Mosse CA, Swain P. A novel use of T -tag sutures for
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44 Ujiki MB, Martinec DV , Diwan TS, et al. Video: natural orifi ce
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46 Horgan S, Thompson K, Talamini M, et al. Clinical experience
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47 McGee MF , Marks JM, Onders RP , et al. Complete endoscopic
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49 Ryou M, Fong DG, Pai RD, Sauer J, Thompson CC. Evaluation
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7
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Mini-laparoscopy in the Endoscopy Unit
Arthur Hoffman & Ralf Kiesslich
Johannes Gutenberg University of Mainz, Mainz, Germany
Introduction
Although a large number of non -invasive techniques for the diagnosis and staging of liver disease have been developed in recent years, macroscopic and histologic evaluation still remains the most accurate method for assessment of the severity and stage of liver disease [1,2]. For a long time laparoscopy was the principal diagnostic method of the gas­troenterologist. The fi rst laparoscopies were performed in 1901 by Kelling, on a dog, and in 1910 by Jacobaeus [3,4]. Laparoscopy was developed into a routine investigation technique for internal medicine in the 1930s, particularly by Heinz Kalk [4,5]. However, following the development of non-invasive diagnostic imaging procedures like ultrasound, CT, MRI, and, recently, endosonography, it faded into the background [6].
Renewed interest in this method in the 1990s was sup­ported by the development of laparoscopic surgical tech­niques and new optics and instruments [7]. This, in turn, stimulated technical progress, which has led to the numer­ous miniature apparatuses and mini -optics of outstanding quality available today [8]. Thus, the gastroenterologist has a means of utilizing the numerous advantages of laparos­copy during a minimally invasive procedure. Despite non ­invasive imaging techniques and diagnostic laboratory procedures, diagnostic laparoscopy – which is performed in sedoanalgesia – is superior to other procedures in several respects, particularly for the purpose of differential diagnosis and for staging hepatologic diseases and gastroenterologic neoplasias [9].
Mini-laparoscopy using a laparoscope with a narrow lumen is less invasive than conventional laparoscopy. A single site of puncture is required for the pneumoperito­neum and introduction of the optical instrument [10].
Indications
Laparoscopy is the diagnostic method of choice for reliable clarifi cation of the question as to whether a patient is suf­fering from liver cirrhosis or fi brosis or not. It also is the method of choice in cases of advanced liver diseases. Fur­thermore, laparoscopy is the most sensitive method to iden­tify peritoneal carcinosis or tuberculous peritonitis [11].
As liver puncture is performed under visual guidance, the method is also suitable for use in patients with a high risk of hemorrhage because such bleeding can be rapidly control­led by coagulation.
There are several other indications for the procedure: biopsy of the spleen in case of suspected lymphoma, clarifi ­cation of surface and subsurface lesions of the liver, clarifi ca­tion of resectability of different tumors, and as a preparatory diagnostic procedure for patients who are potential candi­dates for liver transplantation [12,13].
Staging of chronic liver diseases
New therapeutic options for chronic liver disease require accurate pre -therapeutic diagnosis, especially in terms of identifying liver cirrhosis correctly. In addition to its prog­nostic signifi cance, the identifi cation of cirrhosis affects therapy (for instance, the administration of interferon in the presence of hepatitis C) and initiates surveillance because of the risk of developing hepatocellular carcinoma [14]. Liver biopsy is regarded as the gold standard for the diagnosis of cirrhosis. However, it should be noted that neither percuta­neous liver biopsy nor imaging procedures will be able to entirely rule out the presence of cirrhosis [15]. The mean false-negative rate for percutaneous liver biopsy with regard to the diagnosis of liver cirrhosis was reported to be 24% in 6242 cases (range, 1 –61%) [16,17]. For laparoscopy alone,
Natural Orifi ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,
Ricardo Zorron.
© 2012 John Wiley & Sons, Ltd. Published 2012 by John Wiley & Sons, Ltd.
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CHAPTER 7 Mini-laparoscopy in the Endoscopy Unit
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the rate of false -negative diagnoses was on average 9% (range, 4 –18%) [16,17]. Thus, a combination of macro­scopic assessment and histologic evaluation may be regarded as the gold standard [18]. A retrospective study in 434 patients confi rmed the greater accuracy of macroscopic diag­nosis of liver cirrhosis compared to histologic assessment [18]. In 0.8% of patients with the macroscopic diagnosis of liver fi brosis, histology revealed cirrhosis of the liver. In 32% of patients with cirrhosis of the liver on macroscopic inves­tigation, mere fi brosis was established by histology because histologic criteria for cirrhosis (the presence of a regenerat­ing nodule with perinodular fi brosis or fi brosis encompass­ing large areas of tissue) were not fulfi lled (histology: sensitivity 68%; specifi city 99%; negative predictive value 83%; positive predictive value 98%) [19]. Sampling error was noted in studies of similar magnitude also using mini ­laparoscopic evaluation of the liver and biopsy in 110 patients with liver cirrhosis. The sampling error was attrib­uted to Child ’s A cirrhosis – an inhomogeneous intrahepatic distribution of morphological changes – or macronodular cirrhosis [19].
In diagnostic procedures for chronic viral hepatitis without cirrhosis as well, a laparoscopic biopsy performed for the purpose of comparison revealed, in 20 of 85 patients (23.5%), diverse histologic outcomes as regards infl amma­tory activity and damage to liver parenchyma [20]. A similar extent of histologic lesions in both liver lobes was observed only in 5% of patients.
These data confi rm the relevance of combined macro­scopic and histological assessment of the liver with targeted biopsy of altered regions on gross investigation.
Advanced liver diseases/focal liver diseases
One indication for laparoscopy is differential diagnosis in the presence of ambiguous granulomatous liver diseases such as
sarcoidosis of the liver or Hodgkin ’s and non -Hodgkin’s lymphoma [21]. For the diagnosis of hepatic invasion due to a Hodgkin ’s or non -Hodgkin’s lymphoma, a specifi city of 100% was reported for laparoscopic assessment of the liver and targeted biopsy of focal lesions. However, the sensitivity was only 40% [21].
Underlying hemato -oncological diseases are another important indication for the procedure, especially in patients undergoing a specifi c therapy. For instance, in cases of unclear hepatopathy after bone marrow or stem -cell transplantation, the differential diagnoses may include graft -versus-host disease, veno -occlusive disease, infectious liver disease, or recurrence of the original disease [22]. Besides, patients with HIV disease in the stage of AIDS may demonstrate infectious or malignant involvement of the liver. As the confi rmation of a specifi c diagnosis has a decisive impact on subsequent treatment, laparoscopy is urgently indicated as a diagnostic procedure for conclusive identifi cation of unclear abdominal fi ndings such as Kaposi ’s sarcoma of the liver [23].
Staging of malignant intra-abdominal tumors
The purpose of laparoscopic investigation for staging malig­nant tumors of the abdomen is to avoid unnecessary surgery [24,25]. By the use of mini -laparoscopy, the investigator is able to assess the peritoneum but not the retroperitoneal space. The superiority of laparoscopy with targeted biopsy (as opposed to imaging procedures) for the diagnosis of malignant spread of gastrointestinal (GI) tumors into the liver or the peritoneum has been proven in several studies [25–35]. The sensitivity and specifi city of laparoscopy were markedly higher than those of imaging procedures. This was because the technique permits identifi cation of infi nitesimal lesions less than 10 mm, and provides a means of obtaining histologic confi rmation of suspicious fi ndings by performing a biopsy (Figure 7.1).
Figure 7.1 The superiority of laparoscopy with targeted biopsy for the diagnosis of malignant spread of gastrointestinal tumors into the peritoneum.
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