Endoscopic suturing devices developed for gastric fold plication have undergone a series of redesigns and retesting in laboratory animals over the last decade. The initial trial of suturing in humans was published in abstract form in 1994 by Swain and colleagues. Endoscopic suturing of proximal gastric fundic folds (gastroplasty) is designed to alter the anatomy of the GEJ by cinching the cardia along the lesser gastric curvature accentuating the angle of this.
Device: EndoCinch System
The Bard Interventional Endoscopic Suturing System (EndoCinch) was approved by the US FDA for clinical use as an alternative treatment modality for GERD in May 2000. This system originally included a miniature-sewing capsule attached to an endoscope, a knot pusher, metal-tagged sutures, and suture cutter. The current model has a small ring and peg-cinching tag that obviates the necessity for hand-tying knots, cutting suture ends, and cinching together the tag parts at the surface of the gastric tissue (Swain et al, 2000).
Procedure The EndoCinch procedure requires an overtube and two upper endoscopes. The metal sewing capsule is attached to the tip of the first endoscope; the second endoscope cinches sutures through a catheter device that deploys a ceramic plug and ring through which the sutures are threaded. Only two intubations per procedure are necessary.
A 19.7 mm overtube is inserted over a 15-mm Savary-type dilator and advanced over a guidewire into the stomach. The first endoscope with mounted sewing capsule is passed through the overtube below the GEJ to the desired location. Gastric tissue is aspirated into the hollow end of the sewing capsule for 10 seconds. A handle attached to the biopsy port on the endoscope advances a hollow-core needle, which has been back-loaded with a metal tilt-tag attached to a 3.0 suture through the sectioned tissue. A stiff wire pushed through the hollow needle by the control handle drives the metal tilt-tag forward to be captured into the sewing capsule tip. The suturing system is withdrawn through the overtube along with the tilt-tag attached to the suture. The same tilt-tag suture is reloaded into the hollow core needle and the sewing procedure is repeated. The second stage is optimally placed 1 to 1.5 cm away from the first stitch. Subsequently, the two stitches are pulled together and cinched by the ceramic plug and ring attached to the second endoscope (Figure 13-3).
Effect Two to three plications are formed during the EndoCinch procedure. The plications most commonly are placed circumferentially 1 cm below the GEJ at the 3-6-9 o'clock positions or in linear fashion 1,2, and 3 cm below the GEJ. The majority of the stitches are placed in the submucosa. The initial multicenter study used a technique that averaged 8 steps per plication (repeated for each additional plication) (Filipi et al, 2001). The mean procedure time took 68 minutes, and 17% of patients required general anesthesia. A more recent publication of experience using the EndoCinch technique reported a mean procedure time of 45 minutes (range
FIGURE 13-3. EndoCinch (Bard Interventional Endoscopic Suturing System, CR Bard Inc, Murray Hill, NJ). Step-wise sequence of application is shown top left to bottom right.
25 to 100 minutes). Conscious sedation included the use of midazolam (mean dose 21 mg [range 8 to 60 mg]) and pethidine (mean dose 108 mg [range 25 to 100 mg]).
The therapeutic effectiveness of the EndoCinch gas-troplication procedure to "tighten" the cardiac component of the acid reflux barrier has been compromised by the instability/loss of the submucosal stitches over time. In a recent preliminary report, a gastroplication procedure was performed in 96 patients. A total of 250 sutures were placed. Endoscopic surveillance of suture integrity was performed at three intervals following the procedure. At median of 14 weeks surveillance only 39% of all patients had all plications intact, and at median of 29 weeks only 8% of patients had preserved plication. At the third endoscopy at 62 weeks, none of the sutures were observed intact (Ben-Menachem et al, 2003). In fact, the permanence of the plication sutures has been sufficiently problematic that welding (cautery) of the adjacent gastric folds has been attempted to augment plication security (Lehman et al, 2002).
Device: ESD System
The Wilson-Cook Endoscopic Suturing Device (ESD) received FDA approval in 2003. The device consists of a flexible Sew-Right device with proximal grip handle and Ti-Knot device, external accessory tube attachable to the flexible upper endoscope, suture (braided 2.0 polyester), and a titanium knot-dipping device. This instrument requires only one intubation procedure to form multiple plications because the Sew-Right and Ti-Knot devices can be reloaded through the external accessory tube. The Sew-Right element contains 2 needles controlled by a toggle switch. A continuous single suture is used to stitch adjacent gastric folds beneath the SCJ (Figure 13-4).
The external accessory channel is secured to the upper gastrointestinal endoscope. The Sew-Right unit is loaded with suture and a vacuum cap is advanced distally over the sewing device. The ensemble is inserted into the accessory channel and advanced into the stomach where it is visualized by the endoscopist. A needle selector on the toggle switch is oriented to the right. A proximal gastric fold is aspirated into the vacuum cap and suction applied through a port on the handle mechanism. Squeezing and releasing the handle grip extends the first (right) needle outward, securing the suture, and dragging it through the tissue. Subsequently, the needle returns to its former position. suction is released, the needle selector or the handle is switched to the left and the second needle is advanced in similar sequence.
The sewing unit is removed. The suture ends are back-loaded through the distal end of the Ti-Knot. The Ti-Knot unit is passed through the accessory channel over the two sutures to the surface of the gastric folds. A proximal level on the Ti-Knot is squeezed, which crimps a preloaded titanium knot while simultaneously severing the excess suture.
Despite FDA clearance for clinical use, there is no information available currently about the effectiveness of gastric plication stitches applied through this mechanism.
Device:Full-Thickness Plication System
The full-thickness endoscopic plication system (NDO Surgical Inc, Mansfield, MA) device consists of a reusable instrument with a control handle, which actuates the distal end of the device, providing retroflexion and opening and closing the instrument arms and deploying a suture-based implant. The instrument contains two channels. A tissue helical retractor, designed to penetrate the gastric fold to the depth of the serosa, is inserted through the first channel. The retractor is made of stainless steel and biocompatible polymers and includes a protective sheath covering, which stabilizes the mucosal surface while securing the gastric wall and pulling it into the outstretched instrument arms. The second channel provides passage of a 5.9 mm pediatric endoscope for direct visualization of the procedure. The implant affixed to the open arms of the plicator consists of pretied 2.0 suture prethreaded onto 2 titanium retention bridges. The suture bolsters are made of soft, flexible expanded polytetrafluoroethylene materials (Figure 13-5).
A 60 F overtube is inserted over a 54 F Savary dilator, which passed over a guidewire into the stomach (Figure 13-6). The plicator is passed through the overtube 10 to 12 cm below the GEJ. The overtube is subsequently retracted into the esophagus proximal to GEJ (see part 1 of Figure 13-6). The stomach is distended with air and the plicator is retroflexed viewing the anterior side of the cardia (see part 2 of Figure 13-6). Once the plicator is positioned, the arms are opened and the catheter with the corkscrew tip is advanced to penetrate the gastric tissue to the serosa within 1 to 2 cm of the GEJ (see part 3 of Figure 13-6). Following this, the full thickness of the gastric wall is retracted into the span of the open arms (see part 4 of Figure 13-6). The instrument arms are closed (est. 5 cm "bites") and the implant is deployed forming one large plication composed of 2 full-thickness segments of the cardia (see part 5 of Figure 13-6). The device is disengaged from the implant, the arms are closed, and the instrument is straightened and removed together with the endoscope.
The plicator provides deeper gastric cardia apposition in forming the plication than the other suturing devices. It is anticipated that over a period of time, there will be "fusing" of the opposing serosal sides of the stomach wall with tightening of the cardia providing increased durability of the plication.
In the initial publication, mean procedure time was 21 minutes. Midazolam and meperidine were administered
FIGURE 13-6. Stepwise sequence of Plicator system technique.
FIGURE 13-6. Stepwise sequence of Plicator system technique.
as conscious sedation, but no dosages were given. This device has not yet received FDA approval for clinical use.
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