INTRODUCTION
Bariatric surgery has emerged as the most effective treatment modality for achieving substantial and sustained weight loss in patients with morbid obesity. Beyond its efficacy in weight reduction, bariatric surgery has been shown to reduce long-term total mortality by approximately 40%, with particularly notable decreases in mortality related to diabetes, cardiovascular disease, and cancer [
1].
Postoperative leaks and fistulas occur in 1%–9% of laparoscopic sleeve gastrectomy (LSG) and 2%–5% of Roux-en-Y gastric bypass, with a leak-related mortality of 0.5%–10% [
2]. Traditional management of postoperative leaks and fistulas has included conservative measures such as broad-spectrum antibiotics, percutaneous drainage, and surgery. However, surgical re-exploration, while sometimes necessary, carries substantial morbidity in already compromised patients. Endoscopic interventions have emerged as minimally invasive alternatives. Self-expanding metal stents (SEMS) can effectively seal the defect, promote healing, and divert gastrointestinal contents away from the leak site, thereby allowing for oral intake during the healing process. However, conventional stents were not specifically designed for bariatric leaks, and the risk of stent migration was considerably high, occurring in up to 58% of cases [
3]. Additionally, partially covered stents, which were used to prevent migration, were often difficult to remove due to tissue ingrowth into the uncovered mesh portion. To address these shortcomings of conventional stents, a new longer stent has been specifically designed with an extended length capable of covering the entire sleeve for the management of leaks after LSG, demonstrating significantly reduced migration rates compared to conventional stents [
4]. However, this Mega Stent frequently induced traumatic ulcers, bleeding, and even perforation at the distal end due to impaction against the pyloric or duodenal wall, resulting in poor tolerance. To address this limitation, round-ended stents were developed. We present two cases of successful endoscopic management of persistent gastric leaks following LSG using long, fully covered, round-ended stents after failed surgical re-exploration.
DISCUSSION
The two cases presented demonstrate successful application of long, fully covered SEMS, Gastro-Seal stent in managing persistent gastric leaks following LSG after failed surgical reexploration. Both patients achieved complete fistula closure without stent migration. Notably, both patients resumed oral intake within 2–4 days after stent placement, significantly improving quality of life compared to nil per os status required with surgical management alone. Early oral intake facilitates nutritional recovery and potentially accelerates healing.
Gastric leaks remain one of the most serious complications following LSG, occurring in 1%–9% of cases. The proximal staple line near the esophagogastric junction represents the most common leak site, as observed in both cases. This predilection is attributed to higher intraluminal pressure, increased tissue tension, relatively poor blood supply, and technical difficulties in achieving adequate staple line reinforcement. Traditional management has included antibiotics, percutaneous drainage, and surgery. However, as demonstrated in both cases, surgical identification and repair can be extremely challenging due to severe inflammatory changes and tissue friability. In Case 1, despite emergent surgical exploration, the leak site could not be identified, necessitating feeding jejunostomy placement. Similarly, in Case 2, despite laparoscopic repair with omentopexy, the leak persisted.
Endoscopic interventions have increasingly been recognized as effective, minimally invasive alternatives to surgery for managing post-bariatric leaks. Various endoscopic techniques have been described, including over-the-scope clips, fibrin glue injection, endoscopic vacuum therapy, endoscopic suture, cardiac septal defect occluders and placement of SEMS [
5]. Among these modalities, SEMS can effectively seal the defect, promote healing by excluding gastric contents from the leak site, maintain luminal patency, and allow for oral intake during the healing process, thereby improving nutritional status and quality of life [
2]. However, conventional SEMS, originally designed for malignancies or oncologic anastomotic leaks, demonstrate significant limitations when applied to post-bariatric leak management. The most critical limitation is the unacceptably high migration rate of up to 58% [
3]. This can be attributed to the tubular configuration of the sleeve creating a narrow conduit with smooth walls lacking anchoring landmarks, persistent peristaltic activity generating propulsive forces, negative intrathoracic pressure, and resolution of inflammatory changes causing lumen diameter reduction. Partially covered stents were used to prevent migration through tissue ingrowth; however, this approach created difficulty in stent removal and potentially allowed continued leakage through uncovered portions [
5].
The Gastro-Seal stent used in both cases represented a new generation of stents specifically designed for post-LSG leak management [
6]. With a total length of 240 mm, this fully covered stent was considerably longer than conventional stents (typically 100–150 mm) and featured a round ending for reducing trauma and a larger head for preventing migration. The extended length and larger diameter (shaft 28-mm; edges 36-mm) significantly reduced the migration risk by providing broader gastric wall contact across a larger surface area, and the distal end impacting against the pyloric or duodenal wall also prevented migration. Large, fully covered Mega Stent used to treat bariatric surgery leaks have significantly reduced the risk of migration to 18%, with a leak healing rate of 82% [
7,
8]. However, Mega Stent frequently induced ulcers, bleeding, and even perforation in the antrum and duodenum due to impaction of the distal end of the stent [
7,
8]. This poor tolerance necessitated premature stent removal. In contrast, the Gastro-Seal stent with its round ending was designed to reduce trauma and ulcer formation [
6]. No ulcers were observed in our cases, and both patients tolerated the stent well. A retrospective study analyzing 37 patients treated with 24-cm fully covered bariatric stents (Hanaro ECBB stent or Hanaro Gastro-Seal stent) reported a 100% technical success rate [
9]. The mean stent dwell time was 29.08 days, and leaks resolved in 29 cases (78.37%). Despite the large stent flanges, stent migration was high, occurring in 21.62% (8 of 37) of cases. All migrations occurred when the stent was placed in the post-pyloric position. This finding may explain why our stent did not migrate in our two cases, even though no additional anchoring techniques such as clips or sutures were used, because they were placed in a pre-pyloric position. In the post-stent removal analysis from that study, complications included 10 ulcers and 2 contained perforations. The study indicated that pre-pyloric positioning was as-sociated with a higher rate of ulceration. However, the authors did not provide ulceration rates categorized by specific stent type (ECBB vs. Gastro-Seal), despite the Gastro-Seal stent’s design incorporating atraumatic rounded edges specifically intended to prevent distal ulceration. In contrast, pre-pyloric ulceration was not observed after stent removal in any of our cases, nor were there any symptoms suggestive of esophageal or sleeve stenosis or perforation during the follow-up period. A technical difficulty in the insertion of a long stent such as the Gastro-Seal is that the total length of the stent before deployment is significantly longer than the indicated functional length, the proximal end can sometimes initially extend into the oral cavity during the initial positioning phase. However, by continually deploying the distal end of the stent using the pre-pylorus as a crucial anatomical reference point, the proximal end consistently settled well within the esophagus in both cases.
Fig. 5 shows the images of the long bariatric stents used to date, and
Table 1 summarizes their respective characteristics.
In both cases, successful closure of fistulas was achieved without migration or trauma ulcers using long, fully covered SEMS, the Gastro-Seal stent, for managing persistent gastric leaks following LSG after failed surgical re-explorations. These cases suggest that the Gastro-Seal stent may be a viable treatment modality in sleeve gastrectomy leaks.
The primary limitation of this report is its nature as a small case series, which inherently limits the generalizability of our findings. To confirm these results, a larger series of cases or prospective studies would be necessary.
We presented two cases of successful endoscopic management of persistent post-LSG leaks using long, fully covered Gastro-Seal stents following failed surgical re-exploration. Both patients achieved complete fistula closure without stent migration or traumatic ulceration. The extended length and roundended design of the Gastro-Seal stent appeared to address the key limitations of conventional stents. Our experience suggests that the Gastro-Seal stent represents a promising treatment option for managing post-bariatric leaks. Further prospective studies with larger sample sizes are warranted to confirm these findings.