Ann Thorac Surg 2006;82:702-706
© 2006 The Society of Thoracic Surgeons
New technology
New Covered Mushroom-Shaped Metallic Stent for Managing Anastomotic Leak After Esophagogastrostomy With a Wide Gastric Tube
Xin-Wei Han, MD, PhDa,*,
Yong-Dong Li, MD, PhDc,
Gang Wu, MDa,
Ming-Hua Li, MD, PhDc,
Xiu-Xian Ma, MDb
a Department of Radiology, the First Affiliated Hospital, Zhengzhou University Zhengzhou, Henan Province, Zhengzhou, China
b Department of Surgery, the First Affiliated Hospital, Zhengzhou University Zhengzhou, Henan Province, Zhengzhou, China
c Department of Radiology, the Sixth Affiliated People's Hospital, Shanghai Jiao Tong University, Shanghai, China
Accepted for publication February 27, 2006.
* Address correspondence to Dr Han, No.1, East Jian She Road, Zhengzhou, Henan Province, Zhengzhou 450052 China (Email: hanxinwei{at}tom.com).
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Abstract
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PURPOSE: To evaluate the clinical results of a new covered mushroom-shaped metallic stent for managing gastroesophageal anastomotic leak after esophagogastrostomy with a wide gastric tube and gastric pull-up.
DESCRIPTION: The stent is a self-expanding prosthesis especially designed for occlusion of the esophago-thoracic anastomotic leaks after esophagogastrostomy. From January 2002 to September 2005, 8 patients with gastroesophageal anastomotic leaks were treated with stents. Information about the technical success of stent placement, definitive closure of leak, stent removal, and complications were obtained.
EVALUATION: Stent placement was technically successful in all patients, without immediate procedural complications. The stent completely sealed off the fistula in all patients, and 30-day mortality was nil. Follow-ups at 7 to approximately 30 months showed that all leaks were healed without stent-related complications, and the stents were removed after approximately 18 to 48 days. Two patients died, and the remaining 6 patients were alive with no evidence of disease at the time of this report.
CONCLUSIONS: The use of a new covered mushroom-shaped metallic stent proved expedient, safe, and effective in the treatment of gastroesophageal anastomotic leaks.
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Introduction
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Anastomotic leakage is the most important surgical complication after transthoracic esophagectomy. Leaks from thoracic anastomosis occur in 0% to 30% of cases and carries mortality rates as high as 30% to 60% [1–3]. The most efficient treatment of such leaks remains controversial and there is no standard management of gastroesophageal anastomotic leaks.
Covered stents are emerging as the treatment of choice in palliative malignant dysphagia caused by advanced esophageal cancer, and interventionists have found that these devices are also effective in closing leaks and fistulae. In spite of the many advantages of self-expanding metal stents, limitations and difficulty are encountered in esophageal stenting because of the presence of major anastomotic leaks in the absence of appreciable luminal constriction starting at the gastroesophageal anastomosis after esophagogastrostomy with wide gastric tubes and gastric pull-up, and treatment with a large diameter stent may exacerbate the dehiscence of the anastomosis. Therefore the purpose of our study was to evaluate the efficacy of a new designed self-expanding metallic stent in the treatment of gastroesophageal anastomotic leaks after esophagogastrostomy.
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Technology
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Patients
From January 2002 to September 2005, 8 patients were identified as having a clinically significant anastomotic leak after esophagogastrostomy with wide gastric tubes and gastric pull-up. All patients were men with a mean age of 61.13 ± 11.83 years (range, 38 to 71 years old) who were treated with the specially designed covered mushroom-shaped metallic stents (Micro-Tech Co, Nanjing, East China). Five patients had a fistula after 1 to approximately 7 weeks of conservative treatment of a leakage, and 3 patients had undergone jejunostomy before they came to our department.
Seven patients with anastomotic leaks had cancer of the esophagus, and consequently underwent esophagogastrostomy through a left-sided thoracoabdominal approach; one patient had a peptic ulcer of gastric fundus through an abdominal approach. The tumors of 7 patients had at least stage III before esophagogastrostomy, squamous cell carcinoma of the esophagus or gastric cardia, whatever the lymph node status. The interval between esophagogastrostomy and a significant fistula confirmation was 12.50 ± 8.50 days (range, 3
30 days), but the interval between a significant leak confirmation and stent placement was 33.86 ± 19.14 days (range, 355 days) (Table 1).
Anastomotic leakage was detected by reviewing the patient's history and findings at esophagogram with contrast medium (Ultravist 300 [Schering, Guang Zhou, China]), computed tomography, and endoscopy. Peri-anastomotic and pleural drainage was performed in all patients under computed tomographic or ultrasound guidance once detection of the leakage was found due to significant mediastinal infection or acute mediastinitis and systemic sepsis before referral to our department. Endoscopic biopsy specimens of gastroesophageal anastomotic areas from all patients after esophagogastrostomy were histologically examined before the procedure, which revealed no evidence of tumor cells in 7 patients and peptic ulcer in 1, and a contrast swallow (Ultravist [Schering]) examination revealed an anastomotic leakage into the mediastinum in 2 patients (cases 2 and 7) and into the thoracic cavity in the remaining 6 patients after admission to our department.
Stent Design and Insertion Procedure
The stent (Micro-Tech [Nanjing]) is woven from a single thread of 0.16-mm in diameter, highly elastic nitinol wire that consists of three parts (ie, the head, body, and tail) that are covered with polyethylene membranes in all. The stent body has an internal diameter of 18 mm and is 5080 mm long. The stent body is tubular-shaped, and the flanges at the head and tail ends have a diameter of 24 mm and 5080 mm, respectively. The flange at the head is 20-mm long with an acute angle. A bulging area below the flange just straddling over the esophagogastrostomy anastomosis has a diameter of 24 mm and a length of 10 mm, which is added to prevent stent migration. The flange at the tail end is a mushroom fimbriated configuration (10-mm long) with an acute angle. The head, body, and tail are connected without overlap with use of nitinol wire and polyethylene. Three radiopaque markers made of gold wire are attached at both ends and in the middle of the body part to facilitate precise placement of the stent. The stent is especially designed for sealing off gastroesophageal anastomotic leaks and is constructed according to our specifications. To prevent further migration of the stent, a silk thread is attached from the edge of the wire of the proximal end to the patient's earlobe through the auricle. In addition, there is a retrieval lasso attached inside the proximal end of the stent to allow retrieval and removal of the stent when fistulae are healed (Fig 1).
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Fig 1. Photograph of the covered mushroom-shaped metallic stent. Note also the silk thread (arrow) and the retrieval lasso (arrow).
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Informed consent was obtained from each patient, and our university committee on human investigation approved this study. All procedures were performed under local anesthesia.
Prior to the procedure, a water-soluble contrast swallow (Ultravist [Schering]) is obtained to indicate the proximal and distal borders of the anastomotic leak and the empyema (Fig 2A). The procedure was carried out by two consultant radiologists or by a specialist surgeon under direct supervision. After topical anesthesia (lidocaine, 2%), a 0.035-inch guide wire (Radiofocus M; Terumo, Tokyo, Japan) with a straight 5-French catheter (Torcon NB; Cook, Bloomington, IN) was advanced perorally until the tip reached the gastric body and was then exchanged for a stiffer one (0.035-inch Amplatz super-stiff; Boston Scientific/Medi-Tech, Watertown, MA). A 16-French delivery system (Micro-Tech [Nanjing]) was inserted over the guide wire until the proximal and distal edges of the prostheses bridged the fistula under fluoroscopic control, and the stent was then deployed by pulling back the introducer sheath (Figs 3A–3D). Correct placement of the stent and satisfactory leak occlusion was confirmed by contrast-enhanced fluoroscopy with peroral administration water-soluble contrast (Ultravist [Schering]) after deploying the stent (Fig 2B).
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Fig 2. Gastroesophageal anastomotic leaks in a 70-year-old man who underwent esophagogastrostomy for adenocarcinoma of the esophagus. (A) Endoscopic examination shows leakage of an esophagogastrostomy located at the left posterior wall of the gastroesophageal anastomosis 13 days after esophagectomy. (B) Esophagogram after stent placement demonstrates the leak is sealed off completely with no contrast medium leakage. Note also the expanded tail border of the stent (between the two arrows).
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Fig 3. Diagrams show the technique steps in gastroesophageal anastomotic stent placement. (A) Gastroesophageal anastomotic leak after esophagogastrostomy with a wide gastric tube and gastric pull-up. (B) Passage of an introducer through the gastroesophageal anastomosis after insertion of a guidewire into the residual gastric body. (C) Withdrawal of the sheath over the pusher catheter and deployment of the stent. (D) Expansion of the mushroom-shaped stent in the region of gastroesophageal anastomosis while occlusion of the anastomotic leak.
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Peri-anastomotic and pleural drainage was obtained by existing chest drains or by insertion of additional drains under computed tomographic guidance. All patients received intravenous broad-spectrum antibiotics for 57 days. Finally, the silk thread tied at the edge of the proximal end of the wire was drawn out through the naris and was connected to the patient's auricle. To prevent the esophageal mucosa and oral cavities against irritation form the silk, the silk was threaded through a 14-French rubber tube before being connected to the auricle. Retrieval of the stent was performed fluoroscopically using a retrieval set when the leak was healed or complications occurred. The stent was grasped at the retrieval lasso with the retrieval set and gently pulled out. Usually less than 10 minutes is required for this procedure. Complete healing of the leak was documented by endoscopy, contrast studies, and computed tomography.
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Clinical Experience
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Stent placement in the esophagus and gastroesophageal anastomosis was technically successful and well tolerated in all patients, with no procedure-related complications. Initially all patients required the placement of only one stent. A contrast swallow was obtained immediately, which demonstrated the fistula was closed in all patients after deploying the stent with no contrast medium leakage. Two patients felt dull chest pain for 1 to 4 days after stent placement. Thirty-day mortality was nil. With occlusion of the stent placed during follow-up, 8 stents were placed.
Follow-Up Data
During follow-up (mean survival, 70.63 ± 44.47 weeks; range, 5125 weeks), all leaks were healed without stent-related complications, and the stents were removed after approximately 18 to 48 days (mean, 32 ±11.07 days) with no occurrence of obvious mucosa bleeding. One patient (case 2) had a stricture at the site of the anastomosis develop 5 months after removal of the stent, and the stricture was successfully treated by fluoroscopic balloon dilation. Two patients died of causes unrelated to stent insertion (ie, multiple organ failure [n = 1] and massive bleeding [n = 1]), and the remaining 6 patients are alive with no evidence of disease at the time of this report.
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Comment
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Esophageal anastomotic leakage is a radiologically or clinically apparent esophagogastrostomy anastomotic dehiscence, and clinically apparent thoracic anastomotic leaks incur a mortality reported to be as high as 60% [1–3]. There is no universally accepted algorithm for the treatment of patients with intrathoracic leaks after esophageal resection [4]. Controversies exist as to how to best establish the diagnosis of leakage and whether it should be managed surgically or nonsurgically to achieve the best short-term and long-term outcomes [5]. Strategies of management vary in their invasiveness. They include conservative treatment (ie, antibiotics, percutaneous pleural drainage, nutritional support, and nil-by-mouth only [6]), intraluminal interventions to attempt to seal the leak [7], or repeat thoracotomy at some stage with formal debridement of infected tissue and targeted treatment of the anastomosis depending on local conditions within the chest [8, 9].
Gastric fluid has digestive properties that make leakage extremely noxious. Anaerobic bacteria form the patient's oral cavity and swallowed saliva enter the mediastinum and cause a virulent tissue reaction and infection that can result in mediastinitis, empyema, and multiple organ failure due to negative intrapleural pressure that promotes widespread pleural cavity contamination [3]. In patients with gastroesophageal anastomotic leaks, oral intake is often limited by mediastinitis and septic complications, which often lead to profound malnutrition and death from recurrent infections and sepsis.
Our hypothesis was that insertion of covered self-expanding stents could reduce septic complications of anastomotic leaks and would allow more rapid oral nutrition. Successful sealing of the fistula and rapid oral nutrition ensuring an acceptable quality of life must be the goal of treatment for these patients. In the last few years, self-expanding metal stents have been increasingly used for palliative treatment of patients with nonresectable esophageal cancer and esophago-respiratory fistulas.
However, most currently available stents [10], such as the Wallstent (Boston Scientific, Natick, MA), the Ultraflex stent (Boston Scientific), the Gianturco-Rösch Z-stent (William Cook Europe, Bjaeverskov, Denmark), the EsophaCoil (IntraTherapeutics, St. Paul, MN), the Flamingo stent (Boston Scientific), the FerX-Ella stent (Radiologic Ltd, Prague, Czech Republic), the Choo stent (Solco Intermed Co, Seoul, Korea), the Memotherm (Bard-Angiomed, Karlsruhe, Germany), the Song stent (Sooho Medi-Tech, Seoul, Korea), and the Polyflex esophageal stent (Willy Rüsch AG, Kernen, Germany), have no role in the management of gastroesophageal anastomotic leaks due to the large lumen after esophagogastrostomy with wide gastric tubes and gastric pull-up. This is especially the case in the presence of anastomotic leaks established in the absence of appreciable luminal constriction starting at the gastroesophageal anastomosis. In addition, treatment with a large diameter stent may exacerbate the dehiscence of the anastomosis. All of this has resulted in the development of a new design for the covered mushroom-shaped metallic stent.
One of the major advantages of this stent is that the covered stent provides complete coverage of the gastroesophageal anastomotic leak and reliable occlusion of esophageal anastomotic leaks. Thus, it prevents saliva influx or gastric contains reflux into the leak and also allows more rapid oral nutrition. Since January 2002, 8 patients with anastomotic leaks after esophagogastrostomy were managed by insertion of a stent in combination with interventional drainage and intravenous antibiotics. The patients were advised to sit upright when eating with frequent small meals and to lie in a semi-recumbent position when sleeping; in the meantime all patients were given prophylactic H2-receptor blockade after stent placement to prevent reflux of the gastric acid.
The disadvantage of the stent was oropharyngeal discomfort due to insertion of an oropharyngeal rubber tube. Another limitation was that the stent was especially designed as a gastroesophageal anastomotic closure stent, because it was the only way we could choose to solve the problem. In addition, there are obviously not any contraindications, unless the guidewire can not pass the gastroesophageal anastomosis due to severe stenosis or due to a patient's allergic reaction to the contrast medium.
In summary, on the basis of this outcome analysis and compared with the patients who have gastroesophageal anastomotic leaks, this procedure proved to be expedient, safe, and effective in the treatment of gastroesophageal anastomotic leaks with the use of a new covered mushroom-shaped metallic stent. We believe that the procedure is more quickly and accurately placed by an esophagoscope and fluoroscopic viewing. The interventional treatment with a new covered metallic stent was useful to successfully seal off the gastroesophageal anastomotic leak after esophagogastrostomy with a wide gastric tube.
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Disclosures and Freedom of Investigation
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The authors have performed a free and independent evaluation of this new technology and have no financial relationship with Micro-Tech (Nanjing, China). The tested technology was donated to Micro-Tech, and the stents were provided without charge by Micro-Tech. In addition, the new method of treatment is our original contribution, and we had full control of the design of the study, the methods used, the outcome measurements, the analysis of data, and the production of the written report.
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Disclaimer
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The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.
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Acknowledgments
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We would like to acknowledge Yinghui Ge from the Radiology Department at the People's Hospital, Henan Province, for providing the imaging data.
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References
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Abstract
Introduction
