Clips and Glues

 

Span (mm)


MRI compatible


Rotatable


Can be reopened


Resolution Clip1


11


Up to 3 Tesla, 2500 Gauss/cm


Yes


Up to 5 times


Resolution 3601


11


Up to 3 Tesla, 2500 Gauss/cm


1–1


Up to 5 times


DuraClip2


11


MR safe


1–1


Unlimited


Instinct3


16


Up to 3 Tesla, 1600 Gauss/cm


1–1


Up to 5 times


QuickClip24


7.5, 11


No


1–1


No


QuickClip Pro4


11


Up to 3 Tesla, 1800 Gauss/cm


Yes


Unlimited


OTSC5


11, 12, 14


Up to 3 Tesla, 720 Gauss/cm


No


No


Padlock Clip6


9.5–14


Up to 3 Tesla7


No


No



1 Boston Scientific, 2 ConMed, 3 cook medical, 4 Olympus, 5 Ovesco, 6 US endoscopy, 7 Gauss/cm not available




Boston Scientific


Resolution Clip

Indications for the clip include: bleeding ulcers, hemostasis of upper GI mucosal/submucosal lesions less than 3 cm, arteries less than 2 mm, polyps less than 1.5 cm in diameter, diverticula, closure of GI perforations less than 2 cm that can be treated conservatively, endoscopic marking, anchoring jejunal feeding tubes, and prophylaxis for delayed bleeding.


The clip has a span of 11 mm and can be opened and closed up to five times. It can be rotated, but the response is not one-to-one, and the clip is rated as magnetic resonance imaging (MRI) conditional.


Resolution 360

Indications for the clip include: bleeding ulcers, hemostasis of upper GI mucosal/submucosal lesions less than 3 cm, arteries less than 2 mm, polyps less than 1.5 cm in diameter, diverticula, closure of GI perforations less than 2 cm that can be treated conservatively, endoscopic marking, anchoring jejunal feeding tubes, and prophylaxis for delayed bleeding.


The clip has a span of 11 mm and can be opened and closed up to five times. It can be rotated with a one-to-one response and is rated as MRI conditional (Fig. 26.1).


ConMed


DuraClip

Indications for the clip include: bleeding ulcers, hemostasis of upper GI mucosal/submucosal lesions less than 3 cm, polyps less than 1.5 cm in diameter, diverticula, and closure of GI perforations less than 2 cm that can be treated conservatively.


The clip has a span of 11 mm and can be opened and closed in an unlimited amount of times. It can be rotated with a one-to-one response and is rated as MRI safe.


Cook Medical


Instinct Clip

Indications for the clip include: bleeding ulcers, hemostasis of upper GI mucosal/submucosal lesions less than 3 cm, arteries less than 2 mm, polyps less than 1.5 cm in diameter, and endoscopic marking.


The clip has a span of 16 mm and can be opened and closed up to five times. It can be rotated with a one-to-one response and is rated as MRI conditional.


Olympus


QuickClip2

Indications for the clip include: bleeding ulcers, hemostasis of upper GI mucosal/submucosal lesions less than 3 cm, arteries less than 2 mm, polyps less than 1.5 cm in diameter, diverticula, closure of GI perforations less than 2 cm that can be treated conservatively, and endoscopic marking.


The clip comes with either a span of 7.5 or 11 mm and cannot be reopened. It can be rotated with a one-to-one response but is not rated as safe for MRI use.


QuickClip Pro

Indications for the clip include: bleeding ulcers, hemostasis of upper GI mucosal/submucosal lesions less than 3 cm, arteries less than 2 mm, polyps less than 1.5 cm in diameter, diverticula, closure of GI perforations less than 2 cm that can be treated conservatively, and endoscopic marking.


The clip has a span of 11 mm and can be opened and closed in an unlimited amount of times. It can be rotated but the response is not one-to-one and the clip is rated as MRI conditional (Fig. 26.2).


Ovesco


Over-the-Scope Clip (OTSC )

Indications for the clip include: bleeding ulcers, hemostasis of upper GI mucosal/submucosal lesions less than 3 cm, arteries less than 2 mm, polyps less than 1.5 cm in diameter, diverticula, closure of GI perforations less than 2 cm that can be treated conservatively, and endoscopic marking.


The clip comes with either a span of 11, 12, or 14 mm and is mounted over the scope. It cannot be reopened and can be removed using a special tool provided by Ovesco Endoscopy (Tübingen, Germany) but cannot be reapplied after removal. The clip is rated MRI conditional (Fig. 26.3).

../images/442926_1_En_26_Chapter/442926_1_En_26_Fig1_HTML.jpg

Fig. 26.1

Resolution 360. (Image courtesy of Boston Scientific. Reprint with kind permission. Unauthorised use not permitted)


../images/442926_1_En_26_Chapter/442926_1_En_26_Fig2_HTML.jpg

Fig. 26.2

QuickClip Pro. (Image courtesy of Olympus. Reprint with kind permission. Unauthorised use not permitted)


../images/442926_1_En_26_Chapter/442926_1_En_26_Fig3_HTML.jpg

Fig. 26.3

Over-the-scope clip. (Image courtesy of Ovesco. Reprint with kind permission. Unauthorised use not permitted)


../images/442926_1_En_26_Chapter/442926_1_En_26_Fig4_HTML.png

Fig. 26.4

Padlock Clip. (Image courtesy of US Endoscopy. Reprint with kind permission. Unauthorised use not permitted)


US Endoscopy


Padlock Clip

Indications for the clip include: bleeding ulcers, hemostasis of upper GI mucosal/submucosal lesions less than 3 cm, arteries less than 2 mm, polyps less than 1.5 cm in diameter, diverticula, closure of GI perforations less than 2 cm that can be treated conservatively, and endoscopic marking.


The clip comes with spans of 9.5 or 11 mm for the Padlock clip and spans of 11–14 mm for the Padlock Pro-Select clip. This clip is mounted over the scope. It cannot be reopened. It can be removed but cannot be reapplied after removal. The clip is rated MRI conditional (Fig. 26.4).


Indications for Clips


Indications for Bleeding


Acute Bleeding

Ulcer Bleeding

Peptic ulcers represent the most common cause of upper GI bleed (around 60%) [11], and they require emergency endoscopic intervention to achieve prompt hemostasis. The mortality rate for patients hospitalized for upper GI bleed has been placed between 4.5% and 8.2% [12], making it a significant risk for patients. Endoscopic treatment is recommended for the treatment of ulcers with high-risk stigmata (Classed Forrest Ia and Ib) [13], whereas ulcers with an adherent clot should have the clot removed to evaluate the underlying lesion and treated accordingly [13, 14].


Endoscopic clip use for ulcer treatment has the added benefit of allowing the approximation of the ulcer margin [15]. Its effectiveness could be compromised by the presence of fibrosis at the base or around the ulcer, making it more rigid and more difficult to place the clips. Furthermore, ulcers located on the posterior wall of the duodenal bulb can make it harder to deploy clips effectively [16]. During the treatment of the ulcer, clots are usually removed prior to clipping to better visualize the target site of clip application. The clip is then opened and pointed at the base of a visible vessel, then pressed over it. Suction is then applied to capture more targets in before closing the clip. Finally, the clip is closed and deployed, bringing the tissues together and closing the lesion. More than one clip can be required to achieve proper hemostasis depending on the severity of the ulcer.


An over-the-scope clip could also be used for peptic ulcer hemostasis but requires an en-face approach, whereas through-the-scope clips could be used either en-face or tangentially with similar efficacy [17]. Applying an over-the-scope clip on an ulcer requires pressing the end of the endoscope over the lesion and turning the provided hand wheel clockwise. The open clip presently resting over the scope immediately releases and closes the tissue, aiming to achieve hemostasis.


Clips have been shown to be more effective than injection monotherapy for ulcer hemostasis, with a 78% reduction in bleeding recurrence and need for surgery [18], but are of comparable efficacy to thermo-coagulation [18, 19]. Clips do, however, have a lower risk of perforation when compared to thermo-coagulation, making them a very attractive alternative. Clips could also be used in combination with epinephrine injections to halt bleeding, although this did not show a statistically significant difference in preventing rebleeding compared to clipping monotherapy [18]. Epinephrine injections can be performed either before or after clip placement. Injections after clipping would however be preferable, since injecting prior to clipping would cause the target tissues to swell and may cause the clip to fall off prematurely as the swelling subsides.


Over-the-scope clips have also been shown to be effective in treating peptic ulcer bleeding [20]. A 2017 prospective randomized multicenter trial has shown in its preliminary results that the OTSC was superior than through-the-scope clip and epinephrine injection combination therapy [21]. Further studies still need to be performed, but the OTSC shows real promise in supplanting standard therapies for peptic ulcer bleeding.


Diverticular Bleeding

Diverticular hemorrhages are the most common cause of lower GI bleeds, constituting about 40% of total hospitalizations for LGIB [22, 23]. Although most bleeds resolve spontaneously, endoscopic intervention is sometimes required to stem the bleeding.


There are many options to endoscopically stop diverticular bleeds through clipping. Clips can be applied to close the diverticulum or directly on a bleeding vessel within it. Multiple clips could also be applied one next to each other to close a particularly large diverticulum. For bleeding occurring from a diverticular dome, a clip could be positioned so that one prong lay inside the diverticulum and the other on the outside. Closing the clip then cuts off supply from the vessel leading to the bleeding site [24]. The American College of Gastroenterology currently recommends clipping as the first-line hemostatic technique for diverticular bleeding [25].


Over-the-scope techniques have also been described for the closing of diverticular bleeding [26], where the clip is positioned center on the diverticulum with each prong resting on one edge of the diverticulum. Suction is performed to grab as much tissue as possible and the clip is released, clamping down behind the diverticulum bleeding area. This cuts off the blood supply to achieve hemostasis [27].


Clipping has been proven effective in managing acute diverticular bleeding [25]. It may be preferable to other hemostatic methods because of its lower risk for perforation and its ability to minimize tissue damage [25]. The rate of hemorrhage after clipping was shown to be about 17% [24, 28] with no early bleeding recurrence (defined as <30 days). Clips could be used in this case as markings to determine whether the hemorrhage was de novo or reoccurring. Current guidelines therefore suggest performing hemostasis (preferably clipping) if a non-bleeding visible vessel, a difficult-to-remove adherent clot, or active bleeding is found during colonoscopy [25].


Dieulafoy’s Lesions

Dieulafoy’s lesions account for less than 6% of non-variceal upper gastrointestinal bleeding [29, 30]. They are associated with a 5% mortality rate due to exsanguination [31], posing a real risk to patient safety, and therefore require prompt hemostasis to improve outcomes. Clipping is one such option to achieve hemostasis in these patients.


Hemoclipping was found to be more effective than epinephrine injection for Dieulafoy lesion hemostasis and significantly reduced the chance of bleeding recurrence following treatment [32]. The success rate of clips for treatment of these lesions is well above 90% with a very little risk of rebleeding [3234]. Clipping is therefore very useful as a first-line treatment for Dieulafoy’s lesions. One downside to this method is that some lesions are in hard-to-reach places, such as the lesser curvature of the stomach, the fundus or on the posterior bulb of the duodenal wall. A skilled endoscopist is therefore needed to deploy and successfully use the clip for these lesions. Finally, clips and endoscopic band ligation were similarly effective in treating Dieulafoy’s lesions [30]. Both methods can be considered for such cases.


Successful over-the-scope clip treatment for Dieulafoy bleeding has been described [17, 35, 36]; however, more research needs to be done to compare its efficacy to existing through-the-scope clips and other hemostatic methods.


Mallory-Weiss Syndrome

Mallory-Weiss tears are an uncommon cause of upper GI hemorrhage. They constitute around 5% of all causes of upper GI bleeding [37, 38]. Mechanical hemostasis through clipping offers a practical solution for treating both these tears and the bleeding associated with them.


Endoscopic clipping has been found to be effective for the treatment of Mallory-Weiss tears [3739], with an efficacy similar to endoscopic band ligation [40]. The advantages of using mechanical clipping for the treatment of Mallory-Weiss syndrome hemorrhage include the ability to stop the bleeding as well as closing the physical tear responsible for that bleeding [39]. It may also be a preferable technique to thermo-coagulation, as the esophageal wall is thin and more prone to full thickness perforation, especially if the mucosal wall is already torn.


Over-the-scope clips can also treat Mallory-Weiss tears, with multiple reports showing successful application of the devices to halt bleeding [17, 41]. It is slowly becoming another tool in the endoscopist’s armamentarium to manage these types of lesions.


Prophylaxis

Post-Polypectomy

Post-polypectomy bleeding is an important complication after polyp removal, with an incidence rate between 3% and 8% [42, 43] and delayed bleeding usually occurring within 14 days after polypectomy [44]. Although immediate bleeding can be successfully treated using clipping, current practice can include prophylactic clipping of certain lesions to prevent future hemorrhage. For pedunculated polyp bleeding, the best way to achieve hemostasis is to deploy the clip across the stalk or to clip the base of the polyp. This effectively cuts off the blood supply from the feeding vessel. For sessile polyps, the bleeding region should be clipped first and the lesion on the mucosa entirely closed afterward. Multiple clips could be used for either of these procedures to achieve the desired effect [45].


Categories to stratify polyps for prophylactic clipping are dependent on polyp size (small/mid-sized polyps and large polyps) and polyp morphology (pedunculated/flat polyps).



Small and Mid-Sized Polyps


Small polyps are defined as up to 1 cm in diameter, and mid-sized polyps can be defined as smaller than 2 cm in diameter. In patient populations presenting these types of polyps, prophylactic post-polypectomy clipping tends to be ineffective in decreasing subsequent bleeding episodes [46, 47].


There is still the possibility that prophylaxis could be useful for patients at high risk of GI bleeding. A meta-analysis showed that patients on uninterrupted Clopidogrel therapy had a higher risk of delayed bleeding post-polypectomy. However, the included studies had varying or unknown rates of concomitant Clopidogrel and Aspirin (ASA) use [48]. The effect of Clopidogrel alone on post-polypectomy bleeding is controversial [4850], but a 2015 meta-analysis showed that Clopidogrel alone did increase the incidence of delayed post-polypectomy bleeding [51]. The literature also shows that dual antiplatelet therapy increases the chance of delayed post-polypectomy bleeding [50, 51].


Current guidelines recommend stopping Clopidogrel but not ASA therapy 5 days prior to the procedure or postponing procedures if Clopidogrel cannot be stopped [52, 53]. The effect of prophylactic clipping in these patients has not yet been studied extensively but could potentially eliminate the need to stop antiplatelet therapy prior to procedures. It could also potentially prevent the occurrence of delayed bleeding when antiplatelet or anticoagulation therapy is resumed after polypectomies. One study showed that prophylactic clipping in patients on antiplatelet or anticoagulation therapy was more cost-effective that prophylactic clipping on patients not taking these medications [54].



Large Polyps


Large polyps are defined as 2 cm or larger in diameter. While post-polypectomy clipping has become a more common practice among endoscopists, the efficacy of the practice for prophylaxis in large polyps is subject to controversy. Multiple studies show no added benefit for prophylactic use of clipping in this scenario [47, 55], but these studies are limited by their retrospective nature and the inclusion of some small polyps in their analyses. Two randomized control studies on large polyps showed conflicting results when determining the effectiveness of prophylactic clipping in decreasing the incidence of delayed bleeding [56, 57]. Further studies on exclusively large polyps also show mixed results [58, 59].


It is nevertheless important to note that prophylactic clipping of large polyps could be of use in certain patient populations with high risk of bleeding post-polypectomy. In one study, patients with the following factors were determined to be at high risk of delayed bleeding post procedure: patients older than 75, ASA class of three or more, lesion size of 4 cm or more, Aspirin treatment, and right-sided lesions [60]. These patients might qualify for prophylactic clipping. Accumulating many of these factors raises risk of bleeding up to 40% for the high-risk group. Basing the decision to clip on a score calculated from these factors has been proposed to reduce post-polypectomy hemorrhagic complications [60].


There is as of yet insufficient evidence to recommend general prophylactic clipping of polyps, but prospective randomized control trials are underway to better understand the value of prophylactic clipping in high-risk patients and for large non-pedunculated polyps [61].



Flat and Pedunculated Polyps


Polyp morphology can play a role in determining the probability of bleeding post procedure. Pedunculated polyps were found to be a risk factor for post-polypectomy hemorrhages [62, 63], particularly for pedunculated polyps with large stalks [62]. A larger polyp base was associated with a richer vascularization of the stalk; additionally, while small stalks have linear vessels running through them, larger stalks present with a more irregular pattern to the vessels [62]. This makes these polyps more likely to bleed post polypectomy.


A prospective randomized study has shown no benefit in prophylactic clipping of large pedunculated polyps [64]. A multicenter prospective randomized study also found that the efficacy of clipping was the same as that of endoloop for prophylaxis [65]. A 2016 meta-analysis by Park et al. showed that prophylactic clipping reduced the occurrence of early bleeding in pedunculated polyps [47]. Theoretically, clipping large pedunculated polyps might seem attractive due to the increased risk of bleeding associated with their removal; however, the data is insufficient to recommend this practice.


The efficacy of prophylactic clipping monotherapy on flat polyps is also indeterminate. However, one study showed that combined mechanical and injection therapy did not decrease the risk of early post-polypectomy bleeding in flat polyps [47]. Further research is underway to elucidate the benefits of post-prophylactic clipping on these large flat polyps [61].


Indications for Perforation


Perforations are a rare complication of endoscopic manipulation of the GI tract, with an incidence of 1 in 1000 for therapeutic colonoscopies and 1 in 1400 for nontherapeutic colonoscopies [66]. Although the proportion of iatrogenic perforations is low, the large number of endoscopies performed throughout the world makes it a real risk in absolute terms. Historically, the treatment of choice for these perforations was surgical closure of the lesions, involving invasive procedures and long recovery times. However, endoscopic clips have become an efficient alternative treatment, removing the need for surgery (Table 26.2).


Table 26.2

Indications for perforation closure



































Clips


Indicated for perforation


Resolution Clip1


Up to 2 cm


Resolution 3601


Up to 2 cm


DuraClip2


Up to 2 cm


Instinct3


No


QuickClip24


Up to 2 cm


QuickClip Pro4


Up to 2 cm


OTSC5


Up to 2 cm


Padlock Clip6


Up to 2 cm



1 Boston Scientific, 2 ConMed, 3 Cook Medical, 4 Olympus, 5 Ovesco, 6 US Endoscopy


Surgical rescue of iatrogenic gastrointestinal perforations has a morbidity rate of 36% and mortality of 7% [67]. Clipping of perforations has a success rate of around 90% with through-the-scope clips and around 88% with over-the-scope clips [68]. Endoscopic clips are therefore an effective alternative to surgical repair for perforations depending on the size of the lesion, with large perforations (>1 cm) proving more difficult to close than smaller ones [68].


One study performed on a porcine model (N = 8) showed a 25% rate of leakage for endoluminal closure of large perforations [69], while a second study on a similar model indicated difficulty in closing widely spaced incision sites [70]. It is therefore unclear if perforations larger than 1 cm can be reliably closed with through-the-scope clips. In the case of larger gastric perforations, a second technique has proven successful, where either the greater or lesser omentum is suctioned and used as a patch in conjunction with clip application [7173]. For large lesions, standard clips also have the shortcoming of poor bite depth for tissue acquisition; an over-the-scope clip could therefore be beneficial to grasp the muscularis layer more tightly and provide a solid closure of the perforation. This technique has proven effective for perforations up to 3 cm in size and could be promising as a first-line approach for iatrogenic perforations followed by surgery if unsuccessful [74]. Since endoscopic clipping, if successful, does not carry the same risk of complications as surgery, it is recommended to favor this procedure whenever an endoscopist is comfortable enough and adequately trained to perform it.


Fistulae


Gastrointestinal fistulae present a unique challenge for endoscopists. The tissues forming these fistulae tend to be scarred, fibrotic, and less malleable than normal gastrointestinal tissue, requiring more force to approximate the lesion and form a proper closure. Through-the-scope clip monotherapy has been used to successfully close these fistulae [8, 75]. A clip and cautery combination has also been attempted with moderate success in three patients [76]. However, patients in these studies did not undergo long-term follow-ups to establish persisting closure of fistulae and therefore show no data on the reoccurrence of these lesions after treatment. One retrospective study suggests that less than 20% of patients experience lasting treatment success 2 years post-endoclip closure [76].


Studies involving through-the-scope treatment of fistulae have been limited to small patient sample sizes, with a lack of large studies or long follow-up periods. While treating fistulae with these methods seems to be successful in the short term, there is no guarantee that it will result in lasting definitive closure over a longer term. To date, no endoscopic clip has specifically been approved for the treatment of fistulae, although most are approved for the treatment of perforations up to 2 cm.


One method to prevent treatment failure post-clipping involves the use of over-the-scope clips. These clips provide a better approximation of tissues and closure strength which can be very useful when dealing with chronic fibrotic fistulae. So far, multiple case series have studied the performance of over-the-scope clips for this indication (Table 26.3), but reported sample sizes remain small. The OTSC proves to be very successful at initial fistulae closure but the recurrence rate is between 32 and 67% in the three largest reported studies [7779]. The OTSC seems to be somewhat successful for treating fistulae (Table 26.3), but larger prospective studies with long-term follow-ups need to be performed to be able to better understand its efficacy.


Table 26.3

OTSC performance for fistulae







































































































Study author and date


Type of study


Number of cases


Follow-up period


Initial success (%)


Recurrence rate after initial success (%)


Haito-Chavez et al. (2014) [77]


Retrospective


91


Median of 121 days


90.6


57.1


Mercky et al. (2014) [78]


Retrospective


30


Average of 10.4 months


100


47


Baron et al. (2012) [79]


Retrospective


28


1 month


96


32


Winder et al. (2016) [80]


Retrospective


22


Median of 4.7 months


n.s.1


22.7


Law et al. (2013) [81]


Retrospective


21


Median of 148 days


95


67


Surace et al. (2011) [82]


Prospective


19


8 months


n.s.1


58


Mennigen et al. (2013) [83]


Retrospective


14


Median of 5.5 months


100


21


Manta et al. (2011) [84]


Prospective


12


1–3 months


92


a


Von Renteln et al. (2010) [85]


Prospective


4


2 months


50


a


Parodi et al. (2010) [86]


Prospective


4


1–2 weeks


100


a


Goenka et al. (2017) [87]


Prospective


3


1–2 months


66


a


Dişibeyaz et al. (2012) [88]


Prospective


3


0–18 days


33


a



1 not specified


aNo long-term follow-up available

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May 2, 2020 | Posted by in GASTOINESTINAL SURGERY | Comments Off on Clips and Glues

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