We performed a retrospective review of the data of patients who underwent benign fully covered SEMS placement with the Shim's technique for anastomotic leaks after total gastrectomy to treat gastric cancer between January 2009 and December 2016 at the Chonnam National University Hwasun Hospital. Overall, 1,018 patients with gastric cancer underwent total gastrectomy; anastomotic leaks occurred in 24 (2.4%) cases. Open surgery was performed in 679 cases, including 10 (1.5%) anastomotic leaks, and laparoscopic surgery was performed in 339 cases, including 14 (4.1%) anastomotic leaks. Anastomotic leak treatment included endoscopic stent replacement (n=14, 58.3%), endoscopic hemoclips (n=2, 8.3%), surgical repair (n=3, 12.5%), and conservative treatment (n=5, 20.8%). Of these patients, 14 were enrolled in this study (Fig. 1). We obtained consent from all patients and the study was approved by the Institutional Review Board of the Chonnam National University Medical School, Gwangju, Korea (CNUHH-2015-113).

Conventional fully covered SEMS with anchoring thread has been commonly used endoscopic stent for treating esophagojejunal anastomotic leaks after total gastrectomy in Korea. However, this stent can cause embedding into esophageal mucosa by granulation tissue before extraction of stent. We had experience case of anastomotic leaks with a severely embedded stent after use of a conventional fully covered SEMS (Hanarostent^®; M.I. Tech, Seoul, Korea). The embedded stent was removed with great difficultly. The rat tooth grasped at the distal end of stent, and the stent was peeled backward through the inner side of the stent under fluoroscopic control. This patient's leaks resolved after stent retrieval, but severe stricture occurred mid-esophagus. The patient ultimately underwent a second surgery for severe stricture after 1 year because of a persistent stricture despite repeated endoscopic balloon dilation (Fig. 2).

We used a benign fully covered SEMS with a thick membrane and a silk thread (benign Hanarostent^®, fully covered esophageal SEMS with Shim' technique; M.I. Tech) to treat anastomotic leaks in the next patient. This stent has a specially designed silicone membrane that was modified in thickness (0.2–0.24 mm) and a long end of the silicone membrane (5 mm) to prevent overgrowth and ingrowth of granulation tissue. This stent was also applied with an anchoring thread, using the so called Shim's technique to prevent migration [6]. The Shim's technique involves attaching the silk thread at the proximal end of the stent, which can then be moved through the nose and attached to the ear lobe with tape, similar to the method for endoscopic nasobiliary drainage.

Anastomotic leaks were diagnosed via esophagram using gastrografin or endoscopy. Abdominal and chest computed tomographies (CTs) were performed to evaluate fluid collection or abscess formation in the abdomen or chest cavity. Endoscopic benign stent placements were performed for the following indications: 1) endoscopic confirmed leaks at esophagojejunal anastomosis site, 2) hemodynamically stable patients with systolic blood pressure greater than 90 mmHg, and 3) no residual cancer after total gastrectomy. The methods used for endoscopic stent replacement are described in Fig. 3. Patients were consciously sedated with intravenous midazolam and fentanyl during the procedure. The stent length was 4 cm longer than the size of the leaks to ensure sufficient coverage of the esophageal and jejunal margins of leakage sites. The stent was carefully deployed to locate the middle portion of the stent at the leakage site through a guide wire under endoscopic and fluoroscopic control. After stent deployment, the silk thread was removed through the nose and fixed to the patient's ear lobe using tape. Simple chest radiography was checked to confirm the stent position the day after the procedure and then at 1-week intervals. Per-oral intake began with a small amount of liquid, which then progressed to a regular diet. If an abscess or fluid collection was found on abdominal or chest CT, abscess drainage was performed with intravenous broad-spectrum antibiotics. Follow-up endoscopy was performed to check the healing status of the leak site and stent position within 3 weeks based on the results of simple chest radiography and clinical findings. The endoscopist can directly observe the healing status of anastomotic leaks through the space between stent and esophageal lumen without embedding stent. In malnourished patients, an additional feeding tube was inserted within stent under endoscopic guidance to improve nutritional status and decrease the incidence of leakage in the space between the esophageal wall and the stent. All stents were extracted with/without a fluoroscopic guide after checking complete closure or other complications under endoscopic visualization. Follow-up endoscopy was scheduled 3–6 months after leak closures, and then at yearly intervals.

The Student's t-test and χ² test were conducted for continuous and categorical variables. Continuous variables were expressed as mean (standard deviation) and categorical variables, as a percentage (%). Data were analyzed using SPSS version 21.0 (SPSS Inc., Chicago, IL, USA).

A total of 14 patients underwent endoscopic benign fully covered SEMS placement for esophagojejunal anastomotic leaks after total gastrectomy to treat gastric cancer (Table 1). Patients consistent of 12 (85.7%) men and 2 (14.3%) women with a mean age of 69.3±8.8 years. The mean body mass index was 23.6±3.1. Co-morbidities were hypertension (5, 35.7%), diabetes mellitus (4, 28.6%), coronary artery disease (2, 14.3%), and chronic obstructive lung disease (3, 21.4%). The approaches used for total gastrectomy were open (6, 42.9%) and laparoscopic surgery (8, 57.1%). The mean largest tumor size was 35.7±29.4 mm. Tumor stages were Ia (6, 42.9%), Ib (3, 21.4%), II (2, 14.3%), and III (3, 21.4%)

Clinical and endoscopic characteristics are summarized in Table 2. Clinical inflammatory findings of patients were fever (6, 42.9%), leukocytosis (5, 35.7%), and elevated C-reactive protein (8, 57.1%) before endoscopic treatment. The feeding status of patients were NPO (2, 14.3%), sips of water (5, 35.7%), soft diet (4, 28.6%), and regular diet (3, 21.4%) before endoscopic treatment. The mean size of leaks was 13.1 mm (range, 3–30 mm). The duration from operation to stent insertion was 10.7 days (range, 3–35 days). Technical success of stent insertion was achieved in all patients. All patients received benign fully covered SEMS with a thick membrane and a silk thread. The lengths of stent were 8 cm (2, 14.3%), 10 cm (8, 57.1%), and 12 cm (4, 28.6%).

The clinical outcomes and associated variables are summarized in Table 3. Twelve (85.7%) patients had complete resolution from anastomotic leaks after stent extraction, while 2 (14.3%) patients had treatment failure. Two patients died 2 weeks postoperatively, one patient had lung empyema with pneumonia before stent insertion that progressed to acute respiratory distress syndrome, and the other had intraperitoneal abscess that progressed to septic shock. The time interval from stent insertion to extraction was 32.3 days (range, 18–49 days). The overall complication rate was 14.3% (n=2). Embedded stent and migration, which were major complications associated with SEMS, were absent. One patient had a jejunal active ulcer by the distal tip of stent but experienced complete healing after antiulcer treatment. Delayed stricture at large leak area of anastomosis site was found in 1 patient and successfully resolved after repeated endoscopic balloon dilatation.

Per-oral intake was started with a small amount of liquid 24 hours after stent placement, which then progressed to a regular diet. Intravenous broad-spectrum antibiotics were injected in all patients. Combined fluid or abscess drainages were performed for intraperitoneal abscess (6, 42.9%) and lung empyema (5, 35.7%). Improvement of inflammation was seen 2 weeks after stent replacement. Laboratory changes according to endoscopic stent placement are summarized in Table 4. Ten (71.4%) patients received follow-up endoscopy to check the healing status of the leak site and stent position 3 weeks postoperatively. All leaks showed signs of improvement (8, 80.0%) or complete closure (2, 20.0%) under follow-up endoscopy. Endoscopic repositioning was performed in 5 (35.7%) patients due to slight proximal stent displacement. All stents were removed under endoscopy after confirming complete healing of leaks. No additional endoscopic stent placements were needed. Four (28.6%) patients underwent additional feeding tube placement into the deep portion of the jejunum below the stent under endoscopic guidance because of poor appetite and food material remaining in their drainage (Fig. 4).