Increasingly invasive therapeutic endoscopic procedures and laparoscopic surgeries have resulted in endoscopists being challenged more frequently with perforations, fistulas, and anastomotic leakages, for which nonsurgical closure is desired. Devices and techniques are available and in development for endoscopic closure of gastrointestinal wall defects. Currently available devices with excellent clinical success rates include the over-the-scope clip and an endoscopic suturing system. Another device, the cardiac septal defect occluder, has been adapted for use in the gastrointestinal tract. Extensive endoscopic knowledge, a highly trained endoscopy team, and the availability of devices and equipment are required to manage complications endoscopically.
Key points
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Two devices are currently approved by the US Food and Drug Administration for endoscopic closure of gastrointestinal defects, including perforations, anastomotic leaks, and fistulas: the over-the-scope clip and the endoscopic suturing system.
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A third device, the cardiac septal defect occluder, has been adapted for use in the gastrointestinal tract.
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Devices are under development to facilitate closure by improving access to defects and simplifying closure.
Introduction
With the development of natural orifice translumenal endoscopic surgery (NOTES) and as therapeutic endoscopic procedures become more sophisticated, closure for iatrogenic mural defects of the gastrointestinal (GI) tract has become an evolving area in advanced interventional endoscopy. Endoscopic clips were among the first endoscopic devices used for closure of perforations but are less effective for closure of larger defects, because of limited opening distance between jaws, low closure force, and inability to accomplish deep tissue capture. Devices and techniques are under development to facilitate closure of GI wall defects. The ideal closure device should be inexpensive, safe, readily available (on demand), and easy to use and should provide rapid, reliable, and durable closure.
Introduction
With the development of natural orifice translumenal endoscopic surgery (NOTES) and as therapeutic endoscopic procedures become more sophisticated, closure for iatrogenic mural defects of the gastrointestinal (GI) tract has become an evolving area in advanced interventional endoscopy. Endoscopic clips were among the first endoscopic devices used for closure of perforations but are less effective for closure of larger defects, because of limited opening distance between jaws, low closure force, and inability to accomplish deep tissue capture. Devices and techniques are under development to facilitate closure of GI wall defects. The ideal closure device should be inexpensive, safe, readily available (on demand), and easy to use and should provide rapid, reliable, and durable closure.
Indications/contraindications
Endoscopic closure may be indicated in cases of inflammatory or neoplastic fistulas, dehiscence of surgical anastomoses, and iatrogenic or spontaneous perforations of the GI tract. Advanced endoscopic procedures, including large polypectomies, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and peroral endoscopic myotomy (POEM), have become more commonplace, and the mural defects caused by the procedures themselves are amenable to endoscopic closure. Complications from bariatric surgery and colorectal surgery, including chronic anastomotic leaks and marginal ulcers, may also benefit from endoscopic alternatives. An important contraindication to isolated endoscopic closure involves the clinical setting of delayed perforation with peritonitis and septic fluid collections. Table 1 lists indications and contraindications for endoscopic closure.
| Indications | Contraindications |
|---|---|
| Fistulas (inflammatory or neoplastic) | Uncontained perforations |
| Dehiscence of surgical anastomosis | Peritonitis |
| Perforations (iatrogenic or spontaneous) | |
| Mural defects from large polypectomies, EMR, ESD, POEM | |
| Anastomotic leaks | |
| Marginal ulcers |
Devices
In the mid 1990s, endoscopic closure of gastric and colonic perforations with hemostatic clips was reported. Since then, a variety of techniques have been used to close mucosal defects caused by polypectomy, EMR, ESD, POEM, and electrocautery. The need for endoscopic solutions for closure of intentional transmural defects has continued to increase, particularly with current NOTES driven efforts at full-thickness resection. The techniques used in human subjects include an over-the-scope clip (OTSC) (OVESCO, Tübingen, Germany; Padlock, Aponos Medical, Kingston, NH), the endoscopic suturing system (OverStitch, Apollo Endosurgery, TX), and cardiac septal defect occluders.
Over-the-Scope Clip
The OTSC system is an endoscopic hemostatic clip that was first intended for the treatment of nonvariceal GI bleeding. These clips, also referred to as the “bear claw”, are made of elastic biocompatible nitinol capable of full-thickness closure through tissue approximation. The device was approved by the US Food and Drug Administration (FDA) in 2010.
Compared with standard through-the-scope (TTS) clips, OTSCs can provide single application closure for defects up to 2 cm. The OTSC is believed to produce more durable closure than standard TTS clips, because of its ability to apply a greater compressive force, and when used in conjunction with specially designed tissue graspers provides single-layer full-thickness closure of open defects. The OTSC has also been used for resection of submucosal tumors, treatment of bleeding lesions, and esophageal stent fixation.
Endoscopic Suturing System
The endoscopic suturing system is a disposable, single-use suturing device that allows placement of running or interrupted full-thickness sutures using either permanent (polypropylene) or absorbable suture material. In contrast to hemostatic endoscopic clips, the device was specifically designed to simulate hand sewing for any type of tissue approximation. The device is mounted onto a double-channel therapeutic endoscope. One of the advantages of the device is its ability to be reloaded as many times as needed without the endoscope being removed from the patient. The suturing system has rapidly been adopted and used successfully to close persistent gastrocutaneous fistulas, esophageal fistulas, full-thickness resection sites in the stomach and colon, as well as perforations ( Fig. 1 ). Other popular applications include anchoring esophageal stents to prevent migration, suture nonhealing ulcers, bariatric sleeve gastroplasty, revision of gastrojejunal anastomosis after Roux-en-Y gastric bypass, and closing large post-ESD defects.
Cardiac Septal Defect Occluder
The Amplatzer Septal Occluder (ASO) (AGA Medical Group, MN) is a device that was developed for the occlusion of cardiac septal defects but has been used off label for the closure of fistulas in the GI tract. The device consists of 2 self-expandable round disks made of nitinol wire mesh, which are linked together by a short connecting waist. A handful of case reports describe their use in closure of gastrocolonic and esophagotracheal fistulas.
Other
Omental plug closure has been used for years and has been recently studied as a reliable method for closure of acute peptic ulcer perforations. The omental plug is maintained in position within the lumen with mucosal clips. Other techniques that have been evaluated for endoscopic closure include trial of no closure of defect, self-approximating tunnel/flap, and gastropexy. Devices in animal studies include bioabsorbable foam plugs, mucosal clips, Endoloops (Ethicon, NJ), flexible linear staplers, and circular staplers.
Explanation of technique
Over-the-Scope Clip
This discussion focuses mainly on the OVESCO clip, which is the most commonly used OTSC. A clear cap holds a nitinol clip that is affixed to the tip of the endoscope ( Fig. 2 A, B). Caps are available in 3 diameters to accommodate the sizes of various endoscopes: 11 mm, 12 mm, and 14 mm. Caps are also available in different depths to change the amount of tissue that can be grasped during approximation. A clip release is incorporated into the cap. A thread is pulled retrograde through the working channel of the endoscope, where it is fixed onto a hand wheel at the working channel access port of the scope. Alternatively, the Padlock clip has a catheter that runs alongside the insertion tube of the endoscope and is attached to a syringelike trigger, which releases the radial compression clip ( Fig. 3 ). The endoscope is then inserted to the desired target site of closure. Both OTSC devices can be deployed by using suction to bring the targeted areas into the cap.
Two devices exist to aid in tissue apposition and are inserted through the working channel. The first is a twin grasper that has a unique capability to open left-sided and right-sided graspers to obtain opposite sides of an open defect and appose the tissue, theoretically in a full-thickness single-layer-type closure. The tissue in the graspers can then be pulled into the cap device in preparation for deployment. The second device is a retractable tissue anchor set (3 curved nitinol needles), which is also used for approximation of the tissue.
During clip application, the tissue is either suctioned into the cap to secure the tissue or the tissue graspers are more ideally used to pull the captured tissue into the cap for a more robust and deeper tissue capture. Suction can also be used to supplement this capture method. Turning the hand wheel attached to the working channel near the hand dials subsequently results in deployment of the clip by compressing the entrapped tissue. The OTSC can be conveniently used in suitably sized (<2 cm) colonic perforations ( Fig. 2 C, D). The key element to technical success is the positioning of the lesion within the OTSC cap. Misfiring to 1 side of a lesion can affect successful deployment of a second clip over the defect. Reloading a clip can be performed, if a second attempt is needed. More typically, suboptimal closures can be finished with supplemental mucosal clip placements.
OverStitch Endoscopic Suturing System
The OverStitch endoscopic suturing system is composed of an end cap, needle driver handle, and an anchor exchange catheter. The distal tip of the endoscope is attached to the end cap, which has a hinged, curved, hollow needle body, which opens and closes in an arc, simulating the curved needle used in surgery. The needle driver handle opens and closes the suture arm. The suture cassette contains a suture that is attached to a needle tissue anchor and attaches to the suture arm. After a stitch has been placed, the anchor exchange catheter allows the tip of the needle anchor to be exchanged, the needle body withdrawn from the tissue, leaving the stitch in place, and then reloaded with the needle for the next stitch.
One advantage of this suturing method is versatility. The system allows continuous or interrupted stitches to be made of various lengths. The endoscope does not need to be removed from the lumen for reloading needles or cinching. Furthermore, suturing is completed with the equivalent of intracorporeal knot tying, using a cinching device. Location and depth of suture placement and needle penetration can be accurately identified. Tissue depth, especially full thickness, is facilitated by use of a tissue screw catheter (Helix, Apollo Endosurgery, Austin TX), which is deployed through the second channel of the endoscope.
Cardiac Septal Defect Occluder
The ASO is a dumbbell-shaped device composed of 2 self-expandable, umbrella-shaped disks made of nitinol mesh with polyester fabric, which are constrained within a 70-cm delivery catheter and deployed over an endoscopically placed guidewire ( Fig. 1 ). The occluder is an FDA-approved device for the closure of atrial septal defects. The polyester fabric is sewn securely to each disk to help close the hole and serve as a foundation for growth of tissue over the occluder after placement. The device also possesses radiopaque marker bands, which can be used under fluoroscopy. Although the delivery catheter is too short to be passed through an endoscope, a guidewire can be inserted under endoscopic guidance. When the endoscope is withdrawn, the occluder can be introduced over the guidewire. The device apposes the wall on each side of the defect, thus occluding it and creating a platform for subsequent tissue ingrowth and epithelization. These devices can be found in a variety of waist diameters and lengths, depending on the defect that needs closure. Correct positioning of the device before deployment is critical for successful tissue apposition.
Related posts:
Comprehensive Review of Adverse Events Associated with GI Endoscopy
Minimizing, Recognizing, and Managing Endoscopic Adverse Events
Adverse Events Associated with Percutaneous Enteral Access
Complications of Enteroscopy: How to Avoid Them and Manage Them When They Arise
Endoscopic Retrograde Cholangiopancreatography–Related Adverse Events
Closing Perforations and Postperforation Management in Endoscopy
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