Endoscopic closure devices

Several endoscopic closure devices were tested in animal experiments and human studies for closure of GI tract perforations: (1) T‐tags delivered through the hollow needles. (2) Through‐the‐scope endoscopic clips. (3) Over‐the‐scope endoscopic clips. (4) Endoscopic suturing devices.

Several companies (Olympus Optical LTD [Tokyo, Japan], Cook Endoscopy [Winston‐Salem, NC, USA], Ethicon Endo Surgery [Cincinnati, OH, USA]) have previously developed endoscopic suturing systems based on delivery of T‐tags with attached sutures through a hollow needle [1–4]. The T‐tags were placed into opposite edges of the GI tract wall incision. Then, the sutures were pulled and cinched together by various locking mechanisms everting the edges of the closed perforation away from the lumen of the GI tract. The main advantage of T‐tag based suturing system was the ability to deliver multiple T‐tags without the need to remove the endoscope for reloading from the site of the perforation. However, all T‐tag based systems required a blind puncture of the GI tract wall, with possible unpredictable damage to adjacent organs [5]. Only one device of this group (TAS system from Ethicon Endo Surgery) has been cleared by United States Food and Drug Administration for clinical use in humans. However, at the present time none of these systems is commercially available [6].

The current generation of the through‐the‐scope endoscopic clips includes QuickClipPro (Olympus, Tokyo, Japan), Resolution 360 (Boston Scientific, Natick, MA), Duraclip (Conmed, Bilrerica, MA), Lockado and Sureclip (Micro‐tech, Ann Arbor, MI), and Instinct (Cook Endoscopy, Winston‐Salem, NC) [7]. These clips can be closed and reopened to correct the site of clip application and allow predictable rotation of the clip for precise deployment. All the currently available clip devices are ready to use immediately after taking them out of the packet without the need for reloading and are single‐use products.

Deployment of the through‐the‐scope clips results in inverted closure of perforation compared to parallel closure created by surgical suture closure and everted T‐tag closure (Figure 24.1) [2,8–12].

Commercially available in the United States over‐the‐scope endoscopic clips include OTSC^® (Ovesco Endoscopy GmbH, Tübingen, Germany) and Padlock Clip™ (US Endoscopy, Mentor, NH) [6,13–16]. Over‐the‐scope clips require removal of the endoscope from GI tract, preloading of the clip on the distal end of a flexible endoscope, and then advancement of the endoscope preloaded with the over‐the‐scope clip to the site of the clip deployment. Both OTSC^® and Padlock Clip™ are single‐use devices.

Similar to the through‐the‐scope clips, deployment of the over‐the‐scope clips results in inversion of the mucosa and submucosal layer into the GI tract lumen. The size of the defect that can be closed with the over‐the‐scope clip is limited by a relatively small internal diameter of these clips [6]. Unfortunately, if deployment of the first clip failed to close the defect completely, it will be very difficult to place a second clip next to the already deployed clip [17].

Overstitch endoscopic suturing device was introduced into clinical practice in the United States in 2011 by Apollo Endosurgery Inc (Austin, TX) [18]. Overstitch is currently available in two configurations: [18] (1) Overstitch device for double‐channel upper endoscopes GiF2T 160 and GiF 2T180 (Olympus America, Center Valley, PA) and (2) Overstitch Sx system compatible with single‐channel gastroscopes made by all major endoscope manufacturers (Olympus, Pentax, Fuji, etc.). Both Overstitch and Overstitch Sx are very versatile, user‐friendly devices allowing closure of GI tract perforations by separate or continuous sutures of various lengths. Currently available endoscopic suturing device and its predecessors have been successfully used for various clinical applications in numerous acute and survival animal experiments and human studies [19–31].

Key steps in endoscopic management of gastrointestinal perforations

First and foremost is to recognize accidental perforation during endoscopy as early as possible to prevent the morbidity and mortality associated with such a complication. If GI tract perforation occurred, intravenous dose of broad‐spectrum antibiotics should be administered without a delay. We usually give as a first dose 400 mg of Ciprofloxacin and 500 mg of Metronidazole. Second is to close the perforation immediately to prevent spillage of the luminal content into the peritoneal cavity and to restore the integrity of the GI tract. Third is the attention to details on postoperative care for a successful outcome.

Prevent perforation

One could avoid or limit the risk of instrumental perforation by being cautious and gentle with an endoscope. Adherence to the following principles during diagnostic and therapeutic endoscopy may be helpful in the prevention of perforation under various circumstances:

1. Esophageal perforation:
   
   
   
   • Excessive force should be avoided during esophageal intubation in patients with cervical spondylosis.
     
   • Perforations from balloon dilation of an esophageal stricture could be limited by gradually increasing the size of dilation after starting with the smallest dilator and avoiding the use of excessive force during bougie dilation.
   
   
2. Rectal perforation:
   
   
   
   • Evaluate the size of the rectum during slow withdrawal of the endoscope before retroflexion of the endoscope. Patients with a small rectum are at risk for perforation during retroflexion of the endoscope. In patients with a small rectum, consider examining the rectum by slow deflation of rectum or by using a thinner caliber upper endoscope if retroflexion is absolutely necessary to examine the distal part of the rectum.
   
   
3. Colon perforation:
   
   
   
   • Avoid the use of excessive force during the insertion of an endoscope through a sigmoid colon that is either fixed by adhesions or is redundant; instead, use a smaller‐caliber endoscope, use a variable stiffness colonoscope, insertion of a stiffening wire, or a forceps through the biopsy channel, use of an overtube or a double‐balloon enteroscope.
     
   • Aspirate the fluid from the colon segment to prevent escape of luminal contents through the perforation, if it were to happen during excision of polyps.
     
   • Applying a snare on the stalk of a pedunculated polyp away from the wall and tenting it up prior to cautery could limit transmural burn and perforation.
     
   • Injection of ample amount of submucosal fluid and separating the lesion from the muscularis propria is critical to prevent thermal injury to the muscle.
     
   • Piecemeal resection of large polyps may limit deeper injury to the muscle compared to the large en bloc resections.
     
   • Consider surgery if the risk of perforation is high during endoscopic removal of large lesions.
     
   • Spillage of luminal microbial soup through a perforation can precipitate septic shock; hence, it is critical and preferable to avoid elective endoscopy, especially any therapy with a risk of perforation, in a patient with suboptimal GI tract preparation and residual debris in the lumen until it is cleared and cleaned out. For example, poorly prepared colon can lead to fecal contamination of peritoneal cavity, if perforation were to occur; hence, a clean colon is critical. (Similarly, a clean esophagus is critical prior to dilation, especially in patients with achalasia.)
     
   • Because carbon dioxide gets absorbed quickly by the body compared to air [16, 17], use of carbon dioxide instead of air for endoscopy may be beneficial in patients undergoing endoscopic procedures at high risk for perforation.