Fig. 18.1
The gastrojejunal anastomosis (a) is circumferentially injected with sodium morrhuate (b); it is seen here 3 months postprocedure (from Woods KE, Abu Dayyeh BK, Thompson CC. Endoscopic post-bypass revisions. Tech Gastrointest Endosc 2010;12(3):160–6; with permission)
The first published report in patients with dilated GJA and weight regain reported weight loss in 15 of 20 patients at 2 months [47]. A subsequent study of 28 patients with dilated GJA in 2007 resulted in loss of >75% of regained weight in 64% of patients in a mean 2.3 sessions. The approach did not appear to be successful in anastomoses with diameter greater than 15 mm [48]. Another 2007 study of 32 patients retrospectively demonstrated weight loss or stabilization in 91.6% of patients after 1 year of follow-up [46]. A study of 71 patients in 2008 revealed weight maintenance or loss in 72% of patients at 1 year [48]. Although these results are encouraging, the mechanisms by which sclerotherapy work are not entirely clear, and the procedure may induce weight loss via means beyond restoration of restriction [44].
Suturing
Endoluminal suturing platforms have been studied for revision of dilated GJA and gastric pouches. The EndoCinch Suturing System, Incisionless Operating Platform, StomaphyX, and Overstitch are discussed here.
EndoCinch Suturing System
The Bard EndoCinch Suturing System (C.R. Bard, Inc., Murray Hill, NJ) is a versatile platform for endoscopic surgery (Fig. 18.2) [49]. For revision of dilated GJA, the device is used to place interrupted stitches around the GJA after its rim is pretreated with argon plasma coagulation. The mucosa to be sutured is suctioned into a hollow capsule placed on the endoscope tip, and a hollow needle passes suture through the trapped tissue.
Fig. 18.2
The EndoCinch procedure begins with (a) mucosal ablation using argon plasma coagulation, followed by (b) suturing (From Thompson CC, Slattery J, Bundga ME, et al. Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain. Surg Endosc 2006;20(11):1744–8; with permission from Springer Science+Business Media)
The EndoCinch Suturing System has been studied for revision of dilated GJA [49]. In the first study, eight patients with average weight regain of 24 kg from nadir were included; average GJA diameter was 25 mm. An average of 2 interrupted stitches were placed at the rim of the GJA; average postprocedure stoma diameter was 10 mm. Six of eight patients experienced a mean weight loss of 10 kg at 4 months. Three patients had a repeat procedure; two of them had weight loss of 19 kg and 20 kg at 5 months. Average BMI fell from 40.5 kg/m2 to 37.7 kg/m2 and percent EWL was 23.4%. No significant complications occurred during the study.
A randomized double-blinded multicenter trial, RESTORe, compared transoral revision of dilated GJA with sham procedure [50]. Seventy seven patients with mean BMI of 47.6 kg/m2 and GJA diameter >20 mm were included; reduction of GJA to <10 mm was achieved in 89% of the revised group. There were no perforations, and the rate of adverse events was similar to the sham group. Ninety six percent of the revised patients achieved weight loss or stabilization over the following 6 months. In a per-protocol analysis, the revised group had a mean weight loss of 4.7 ± 5.7% vs. 1.9 ± 5.2% in the sham group (p = 0.041). Notably, the revised group had lower blood pressure.
Incisionless Operating Platform and ROSE Procedure
The Incisionless Operating Platform (USGI Medical, San Clemente, CA) is a multichannel instrument that can create full-thickness plications for the treatment of dilated gastric pouch and GJA (Fig. 18.3) [51]. Endoscopic visualization is via 4.9 mm endoscope (GIFN180; Olympus, Center Valley, PA, USA) through one of the four accessory channels. Another channel is used for a tissue grasper. A tissue approximator, g-Prox (USGI Medical), is placed through a third channel. Tissue to be plicated is pulled by the grasper into the g-Prox, and the tissue approximator is closed. This allows the needle to deploy a self-expanding tissue anchor on both sides of the tissue fold. The anchors are connected by suture that runs through the tissue fold. The connecting suture is tightened, which approximates the tissue anchors and the plicated tissue is released. These anchors spread the force load across the wound, optimally supporting tissue remodeling and healing [52].
Fig. 18.3
Incisionless Operating Platform (IOP) (USGI Medical Inc, San Clemente, CA) (courtesy of USGI Medical Inc; with permission)
Endoluminal revision using the platform, or Revision Obesity Surgery Endoscopic (ROSE), has been examined prospectively (Fig.18.4). Mullady et al. enrolled 20 patients with dilated gastric pouch and GJA, resulting in mean post-bypass weight gain of 13 kg [53]. The procedure was technically successful in 85% of cases, with average reduction in pouch length of 2.5 cm (36% reduction) and postprocedure stoma diameter of 16 mm (65% smaller). Mean weight loss was 8.8 kg at 3 months. Ryou et al., using a second-generation device capable of working in smaller pouches, had technical success in 100% of patients and mean weight loss of 7.8 kg at 3 months.
Fig. 18.4
The ROSE procedure begins with (a) grasping tissue at rim of the gastrojejunal anastomosis with a tissue grasper (white arrow), and then closure of the g-Prox (USGI Medical) on the grasped tissue (black arrow), followed by deployment of the first anchor (open arrow). (b) Next, the g-Prox is released from the tissue, and then the second tissue anchor is deployed, thus creating a tissue plication (arrow) (from Mullady DK, Lautz DB, Thompson CC. Treatment of weight regain after gastric bypass surgery when using a new endoscopic platform: initial experience and early outcomes (with video). Gastrointest Endosc 2009;70(3):440–4; with permission)
A prospective multicenter registry of 116 patients included patients with success after RYGB (>50% EWL) and subsequent regain in the setting of pouch and GJA dilation [54]. The procedure was technically successful in 112 patients (97%), with 44% reduction in pouch length and 50% reduction in GJA diameter; there were no significant procedural complications. At 6 months, 32% of regained weight was lost. A subset of these patients with dilated GJA (>12 mm) who had postrepair GJA diameter <10 mm experienced significantly more postprocedure weight loss: 24% EWL vs. 10% for the rest of the cohort [63].
StomaphyX
The StomaphyX suturing system (EndoGastric Solutions, Inc., Redmond, WA) is a fastener delivery device that can address dilation of the pouch or GJA (Fig. 18.5) [55]. It uses 7 mm polypropylene H-fasteners to create full-thickness tissue plications, which can be applied in a circumferential manner in the gastric pouch or at the GJA. Once the pouch or GJA has been measured, the device is attached around the endoscope, and they are positioned so that the StomaphyX passes through the GJA. Tissue 1 cm proximal to the GJA is suctioned into the device, and approximately 20H-fasteners are used to form a tight circular pleat of tissue.
Fig. 18.5
StomaphyX device and H-fastener (EndoGastric Solutions, Inc, Redmond, WA). (from Overcash WT. Natural orifice surgery (NOS) using StomaphyX for repair of gastric leaks after bariatric revisions. Obes Surg. 2008;18(7):882–5; with permission)
Mikami et al. have studied this method in 39 patients with average BMI of 39.8 kg/m2 and average weight of 108 kg [55]. Average % EWL was 10.6% at 1 month, 13.1% at 3 months, and 19.5% at 1 year. Notably, 3 patients with dumping syndrome and 8 patients with GERD had resolution of these symptoms. Another study of 64 patients found average weight loss of 7.6 kg at a mean follow-up of 5.8 months [56].
Apollo OverStitch Endoscopic Suturing System
The OverStitch (Apollo Endosurgery, Austin, TX) is an endoscopic suturing platform that uses a catheter-based actuating needle to place full-thickness running stitches and interrupted sutures under direct visualization (Fig. 18.6). Sutures can be reloaded without removal of the endoscope. Use of a double-channel endoscope permits installation of a tissue retractor, which allows for more accurate suture placement. As only one hand is needed for suture deployment, depth of suture placement and visibility of the operative site can be better controlled [44].
Fig. 18.6
Apollo OverStitch (Apollo Endosurgery, Austin, TX) (courtesy of Apollo Endosurgery; with permission)
The OverStitch has been used to close fistulae and oversew chronic marginal ulcers. It has also been used for revision of dilated GJA successfully in 9 patients. Further study is ongoing [44].
Other Technology
OTSC(R)-Clip
The OTSC(R)-Clip (Ovesco Endoscopy AG; Tubingen, Germany) is an over-the-endoscope nitinol clip attached to an applicator placed on the endoscope tip (Fig. 18.7) [57]. It has been used for gastrotomy, perforation, and fistula closure, as well as successful reduction of dilated GJA. A study of 94 post-RYGB patients with a starting mean BMI of 32.8 ± 1.9 kg/m2 had mean BMI of 29.7 ± 1.8 kg/m2 at 3 months and 27.4 ± 3.8 kg/m2 at 1 year. The procedure was most efficacious when clips were placed at opposite sites, reducing GJA diameter by >80%.
Fig. 18.7
Endoscopic over-the-scope clip (OTSC(R); Ovesco AG, Tubingen, Germany) (from Heylen AM, Jacobs A, Lybeer M, et al. The OTSC(R)-Clip in revisional endoscopy against weight gain after bariatric gastric bypass surgery. Epub ahead of print 2010 Sep. With permission from Springer Science+Business Media)
Olympus T-tags
T-tag devices (Olympus) have been shown to reduce GJA diameter [58]. Each T-tag is made of two distal T-bars in two hollow needles; once these tags are inserted into tissue, a proximal sliding tag is advanced over the connecting suture and secured. An endoscopic loop cutter is used to cut trailing suture after closure. A double-channel endoscope is needed. Tang et al. performed a nonsurvival study in pigs; an average of 4T-tag devices were deployed around each stoma with resulting GJA diameter reduction of 27.3 ± 13.3% [59]. Procedure time was 61 ± 12 min.
Neurohormonal
Bariatric modification of the gastrointestinal tract broadly alters the physiology of appetite. As the physiologic effects of these modifications are elucidated, new endoscopic therapies can be targeted to replicate these effects [60]. However, bariatric procedures may also result in maladaptive neurohormonal responses that result in weight regain. For example, chronic energy-intake deficiency seen after bariatric procedures and decrease in fat mass is accompanied by even more rapid decrease in plasma leptin; this results in a “starvation response” comprising energy conservation and increased appetite [61]. Ghrelin, peptide YY, leptin, and glucagon-like peptide 1 are promising targets for therapy. It has been found, for example, that rats sustaining weight loss after bypass procedures secrete a larger amount of peptide YY and suppress leptin secretion; rats that do not sustain a large peptide YY: leptin ratio regain weight [62]. This work is still in its infancy, but in the future it may be used to guide therapy.
Conclusion
With cumulative increase in the number of patients’ status post-bariatric surgery, postoperative weight regain has become a considerable challenge. Given the proliferation of endoluminal therapies that have demonstrated safety and efficacy in treatment of weight regain, it is clear that endoscopic revision will be an increasingly prominent element in bariatric care.
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