Unusual Applications of Metal Stents in Gastrointestinal Tract



Fig. 5.1
Panorama of esophageal stent. From the left to the right: Partially covered stent (Ultraflex), Polyflex stent, Partially covered stent (Evolution), Fully covered stent (SX-Ella), fully covered stent (Niti-S antimigration), fully covered stent (Alimaxx-E stent)





5.2.3 Benign Esophageal Leakages or Fistula


Benign esophageal leakages or fistula are frequently encountered and require urgent intervention to the high risk of sepsis and the high mortality rate. Anastomotic leakage may occur in up to 10 % of patients undergoing esophageal resection. Also iatrogenic perforation or Boerhaave syndrome have been successfully treated with SEMS. As shown in Fig. 5.2, the placement of covered or partially covered SEMS constitutes an indication to treat an esophageal fistula resulting in a valid alternative to surgery, favoring the healing of the defect in the esophageal wall, the control of sepsis, and a more rapid intake of an oral diet. A recent meta-analysis of Dasari et al. reported data on 117 patients from 12 studies [16]. Technical and clinical successes were 96.5 % and 86.2 %, respectively. Stent migration occurred in 11 % of treated patients. However, five patients had a perforation induced by stent, two of them due to erosion of the wall of the aorta [16]. Endoscopic reintervention and surgical intervention were needed in 5 % and 15 % of cases, respectively [16]. In the same meta-analysis, the authors also considered patients treated with SEPS: the data show that they have a higher incidence of migration and need more frequent endoscopic reoperation, while the need for a surgical intervention does not seem to significantly differ from that of SEMS [16]. The use of SEMS in the treatment of a defect in the esophageal wall must be always taken into account: the choice of the stent must take account of the greater risk of migration in the absence of stenosis. We believe the choice should fall on large-diameter partially covered SEMS. The removal must be programmed within 4–6 weeks, in order to minimize the risk of ingrowth. Also in this scenario, the stent-in-stent technique should be considered in case of embedment [13]. It is also necessary to remember that any periesophageal collection must be drained, and the patient must always be treated with broad-spectrum antibiotics.

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Fig. 5.2
Diagram indications to apply stents in esophageal fistula or rupture (Esophageal perforation In: Tham T, Collins J and Soetikno R, eds. Gastrointestinal Emergencies Oxford: Blackwell Publishing Ltd 2008)


5.2.4 Variceal Bleeding


Active bleeding from esophageal varices is considered a major cause of mortality in patients with decompensated liver cirrhosis. Treatment is currently based on vasoactive drugs, band ligation or sclerosis, and antibiotic therapy; however, they can fail in 10–15 % of patients. Tamponade balloon or the positioning of TIPSS may be proposed in these cases, however in clinical practice, TIPSS is not readily available quickly. Over the past 10 years, many cases of patients with refractory variceal bleeding treated with SEMS with excellent results have been described in literature, so that the 2015 Baveno Workshop on portal hypertension has proposed the placement of SEMS as a possible therapeutic option, awaiting further confirmations from clinical trials [17]. A review by Changela et al. showed data about 103 cases of patients treated with fully covered SEMS: Technical success rate was 97 %, with a bleeding control achieved in 96 % of treated patients. All SEMS were successfully removed after 4–14 days. Stent migration occurred in about 21 % of patients [18]. A more recent systematic review with meta-analysis took into account data on 13 studies [19]. The pooled estimate rates were 0.12 (95 % CI = 0.07–0.21) for variceal bleeding mortality and 0.18 (95 % CI = 0.11–0.29) for failure to control bleeding with SEMS [19]. The available data suggest that a proportion of less than 40 % of patients with refractory variceal bleeding dies 1 month after placement of SEMS. Therefore SEMS could be considered as a bridge therapy in selected patients undergoing other interventions such as TIPSS or liver transplantation. The choice must fall on a completely covered and large-diameter stent. The removal must be scheduled within 2 weeks, making it easier to prevent the removal of the device, reducing the risk of injury and variceal rebleeding.


5.2.5 Esophageal Achalasia


Therapeutic interventions for endoscopic esophageal achalasia include pneumatic dilation, intrasphincteric injection of botulinum toxin, and most recently the peroral endoscopic myotomy (POEM). The rate of clinical remission obtained with pneumatic dilatation, however, dramatically decreases over time from 20 to 60 % in 10 years. Temporary placement of large-diameter SEMS at the level of the cardia has been proposed as a possible therapeutic intervention in patients with achalasia. The rationale of their use is linked to the possibility to perform a gradual and prolonged dilation at the level of the lower esophageal sphincter, which, compared to traditional pneumatic dilation, should secure better long-term results.

In a study by Ying-Sheng, 90 patients with achalasia have been treated with different size SEMS: 20, 25, and 30 mm. Partially covered SEMS have been deployed across the esophageal cardia, and they were left in place for 4–5 days, before being removed. Technical success was achieved in all patients; however, best results were obtained with larger-diameter SEMS: the treatment failure rate was lower in patients treated with 30 mm SEMS (13 %) compared to the other groups [20]. SEMS migration occurred more frequently in patients receiving 20 and 25 mm SEMS. Moreover, patients were followed up to 10 years and larger-diameter SEMS showed better long-term results [20]. Similar results have been reported also in other studies [2123]. In another study comparing SEMS and pneumatic dilation, a temporary, 30-mm diameter SEMS was associated with a better long-term clinical efficacy in the treatment of patients with achalasia [22]. Similar better long-term outcomes have been shown in another study comparing removable SEMS and botulinum toxin injection [23]. While these data are promising, studies from Western countries are lacking, and SEMS dedicated to achalasia are not widespread used.


5.2.6 Staple Line Leaks Postlaparoscopic Sleeve Gastrectomy


The use of SEMS deserves a special mention in the treatment of staple line dehiscence after laparoscopic sleeve gastrectomy. This is the most feared complication of this surgery, providing greater morbidity. Its incidence varies depending on the series but seems to have decreased over time from 2.5 % to 1.1 % [24]. However other authors reported higher incidence of leakages up to 20 %, also in experienced hands [25]. Leakage typically develops at the esophagogastric junction and proximal stomach, near the angle of His. The cause of leakage is to be attributed to an altered healing process of the suture line, which depends on many risk factors, such as ischemia due to the devascularization of gastric wall. An increased intraluminal pressure of gastric tube has also been invoked as another mechanism involved in staple line leaks, especially if the gastric tube is little distensible or if there is a stricture of the sleeve [26]. Although it is not accepted by all, in recent years, several authors have proposed the use of fully covered SEMS in the treatment of this type of fistula with variable results [27, 28]. Only the leakages located at the esophagogastric junction or the proximal portion of gastric tube are susceptible to such treatment. SEMS migration is the most frequent complication, occurring in up to 30 % of cases. Therefore these SEMS should be as wide and as long as possible, in order to prevent dislocation. Many authors remove them after 6–8 weeks to ensure complete healing of the fistula. Recently covered SEMS with a large diameter and length have been introduced on the market, dedicated to the treatment of staple line leaks postlaparoscopic sleeve gastrectomy (Megastent, Taewoong Medical co, South Korea). It is a completely coated prosthesis with a large diameter (24–28 mm) and varying in length from 15 to 23 cm. This stent has two large flares in the proximal and distal part, ensuring an optimal gripping. Moreover, given its length, the proximal and distal ends can be opened upstream of the leak in the esophagus and in the duodenal bulb, respectively. This allows to reset the high pressure within the gastric tube, promoting the healing of the fistula. A recent case series by Galloro et al. showed that Megastent was effective in four patients with staple leaks, allowing rapid resumption of enteral nutrition and early discharge [26] (Fig. 5.3).

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Fig. 5.3
Stent used to treat staple line leaks postlaparoscopic sleeve gastrectomy (a Betastent, Taewoong; b Megastent, Taewoong) (www.​stent.​net)



5.3 Unusual Application of Stents in Low GI Tract


Placement of SEMS within the low GI tract is an advanced endoscopic technique used to treat a variety of condition including obstruction, fistula, and perforation.

The most common indication for low GI tract stenting is the colon malignant obstruction. There are two major indications for colonic stenting in patients with colorectal cancer: palliation of advanced disease and preoperative decompression. In the latter case, placement of a stent can convert a surgical procedure from an emergent two-step procedure (including a colostomy) into an elective one-step resection with a primary anastomosis, which can be performed laparoscopically [29].

Large-bowel obstruction caused by advanced colon cancer occurs in three-fourths of all malignant colonic obstruction. The management of this severe clinical condition remains controversial.

The majority of colon cancer causing obstruction are localized to the left side of the colon, with the sigmoid colon being the most common location. Extrinsic colon cancer (in particular pelvic tumors) can infiltrate the colonic wall and may cause a lumen obstruction or a colonic compression. Malignant colonic obstruction may be treated by using conventional surgery with resection or diversion procedures, but patients presenting with malignant obstruction often are poor surgical candidates. Patients treated with a diverting colostomy frequently retain the stoma indefinitely because of the discovery of metastatic disease [30]. Urgent surgical intervention in this setting is associated with a mortality rate of 10 % and morbidity up to 40 % [31]. The most important endoscopic alternative to the urgent surgical management of malignant colonic obstruction is the placement of SEMS.

Over the last decade, many articles have been published on the subject of colonic stenting for malignant colonic obstruction, including randomized controlled trials (RCTs) and systematic reviews. However, the definitive role of self-expandable metal stents (SEMS) in the treatment of malignant colonic obstruction has not yet been clarified, and a collaborative approach to patient management, including surgeons and endoscopists, is recommended to guide patient care [31].


5.3.1 Self-Expanding Metallic Stents for Malignant Obstruction


Endoscopic placement of colorectal stents is an effective alternative to surgical decompression for colonic obstruction. In a pooled analysis of 54 trials, reporting on 1198 patients with malignant colorectal obstruction, SEMS placement achieved clinical success in 91 % [32]. In the most current review of 88 articles incorporating the results of SEMS placement in 1785 patients for malignant colonic obstruction, clinical success was achieved at a median rate of 92 % [33]. Serious complications, including colon perforations, were reported in 5 % of patients in each of these two papers.

Two precautions emerge from these studies. First, stricture dilation before or immediately after stent placement results in a five- to sixfold higher rate of perforation (10 %–18 %) and should generally be avoided [32]. Second, covered stents may have inferior outcomes compared with uncovered stents because of a significantly higher migration rate (31 % vs. 3 %) [33].

Although excellent right-side colonic SEMS placement outcomes have been reported from expert centers, data are more limited than for left-side colonic SEMS placement.


5.3.2 Colonic SEMS as a Bridge to Surgery


In patients with malignant colonic obstruction who are candidates for surgical resection, placement of a colonic SEMS allows colonic decompression without the morbidity and mortality of urgent surgery.

The most recent systematic review and meta-analysis evaluated the efficacy and safety of colonic stenting as a bridge to surgery (n = 195) compared with emergency surgery (n = 187). All seven RCTs that focused on the postoperative outcome of SEMS and emergency surgery were included in this meta-analysis. The mean technical success rate of colonic stent placement was 76.9 % (range 46.7 %–100 %). There was no statistically significant difference in the postoperative mortality comparing SEMS as bridge to surgery (10.7 %) and emergency surgery (12.4 %). The meta-analysis showed a lower overall morbidity (33.1 % vs. 53.9 %, P = 0.03), a higher successful primary anastomosis rate (67.2 % vs. 55.1 %, P < 0.01), and a lower permanent stoma rate (9 % vs. 27.4 %, P < 0.01) in the SEMS group [34].

According to these results, SEMS placement are related to significantly lower complication rates and shorter hospital stays, better health-related quality of life, and reduced costs.

Moreover, the relief of symptoms provided by SEMS placement allows additional time to stabilize the patient, address underlying comorbid medical illnesses, perform a thorough staging evaluation of the cancer, and offer the opportunity to provide neoadjuvant therapy in patients with rectal cancer. In this way, colorectal stent placement serves as a favorable “bridge to surgery.” For those patients who appear to be surgical candidates but later are found to have widely metastatic disease, the SEMS can be left in place as palliative therapy and a potentially permanent colostomy avoided [35]


Oncological Outcomes

Potential concerns have been found about impaired oncological results after SEMS treatment in the bridge to surgery group patient, particularly following colon stent perforation. The outcome of long-term follow-up comparing SEMS as a bridge to elective surgery versus acute resection was analyzed by three RCTs [3638]. Although the study groups were small (15–26 patients in the stent arms), all trials report higher oncologic disease recurrence rates in the SEMS group. However, no difference in survival was seen in the SEMS group compared with the surgery group in the three trials [3638].

The use of SEMS and the occurrence of tumor stenting perforation were identified to correlate with worse overall survival. The outcome data of the “Dutch Stent-In 2” trial showed a significantly higher overall recurrence disease rate in the SEMS group between the two arms (42 % in the surgical group vs. 25 % in the SEMS group), which was even higher in the subgroup of patients who experienced stent-related perforation (83 %) [38]. The oncological risks of SEMS placement should be balanced against the operative risks of emergency surgery. Because there is no reduction in postoperative mortality and stenting seems to impact on the oncological safety, the use of SEMS as a bridge to surgery could not be recommended as a standard treatment for potentially curable patients. However, placement of SEMS is considered an alternative option in patients at high surgical risk.

Risk factors as increasing age and an ASA score ≥ III are associated with adverse outcomes following elective as well as emergency surgery in colorectal cancer. Therefore, the use of SEMS as a bridge to elective surgery may be considered the preferred alternative treatment option in patients potentially unfit for surgery: older than 70 years and/or with an ASA score ≥ III [39].


5.3.3 Colonic SEMS as Palliative Therapy


Colonic SEMS can also provide effective palliation for patients with malignant colonic obstruction who are recognized at initial evaluation to be poor operative candidates. Follow-up data of colonic SEMS placement for palliation are favorable; the median rate of clinical success was 90 %–93 %, and the median rate of reobstruction ranges from 12 % to 16 % [32, 33] Patients who underwent to colonic SEMS placement as palliative therapy, compared with surgery, had lower medical complications, shorter hospitalization, reduced number of colostomy [40, 41], more prompt initiation of chemotherapy [42], and a trend toward decreased mortality [43].

In recognition of these findings, recent reviews support endoscopic placement of colonic SEMS as an effective approach to palliation of patients with stage IV colon cancer obstruction.

Colonic SEMS also may serve for palliation of rectal cancer. Hünerbein et al. achieved initial technical success in 33 out of 34 patients (97 %) but suggested that stent placement is contraindicated for low rectal cancer (5 cm from anal verge) because of tenesmus and patient’s incontinence [44].

According to the results of two meta-analyses [45, 46], colon SEMS are related to a significant lower 30-day mortality (4% vs. 11 %, SEMS vs. surgery, respectively), a shorter hospitalization (10 vs. 19 days), and a lower intensive care unit (ICU) admission (0.8 % vs. 18.0 %) while permitting a shorter time to initiation of chemotherapy (16 vs. 33 days). Surgical stoma formation was significantly lower after palliative SEMS compared with emergency surgery (13 % vs. 54 %).

No significant difference in overall morbidity between the stent group (34 %) and the surgery group (38 %) has been observed. Early complications did occur more often in the surgery group, while higher late complications were more frequent in the SEMS group. The most frequent stent-related complications in the SEMS palliative group included colon perforation (10 %), stent migration (9 %), and reobstruction (18 %) [45, 46].

Together, these analyses demonstrate that SEMS placement provides cost-effective relief of malignant colonic obstruction with an acceptable rate of complications in a broad population of patients.

Chemotherapy without anti-angiogenic agents (bevacizumab) is not associated with an increased risk of colon stent perforation. Patients who have undergone palliative stenting can be safely treated with chemotherapy without anti-angiogenic agents [47].

Retrospective series found an increased risk of stent-related colon perforation (17–50 %) in patients treated with angiogenesis inhibitor [48]. A meta-analysis found the treatment with anti-angiogenic agents as a risk factor of increased colon perforation during colon stenting: 12.5 % of colon perforation rate was observed in patients treated with bevacizumab compared to 7.0 % of colon perforation registered in patients treated with standard chemotherapy [47]. Considered the high risk of colon perforation identified in this subgroup of patient, the use of SEMS as palliative treatment is not recommended if an anti-angiogenic therapy is being administered [47].

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Aug 23, 2017 | Posted by in ABDOMINAL MEDICINE | Comments Off on Unusual Applications of Metal Stents in Gastrointestinal Tract

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