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Ann Thorac Surg 2006;81:467-472
© 2006 The Society of Thoracic Surgeons

Original article: General thoracic

Nonoperative Treatment of 15 Benign Esophageal Perforations With Self-Expandable Covered Metal Stents

Andreas Fischer, MD * , Oliver Thomusch, MD, Stefan Benz, MD, Ernst von Dobschuetz, MD, Peter Baier, MD, Ulrich T. Hopt

Department of General and Visceral Surgery, Albert-Ludwigs-University, Freiburg, Germany

Accepted for publication August 25, 2005.

* Address correspondence to Dr Fischer, Surgical Endoscopy, Department of General and Visceral Surgery, Albert-Ludwigs-University, Hugstetterstr 55, Freiburg 79106, Germany (Email: andreas.fischer{at}uniklinik-freiburg.de).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: Spontaneous or iatrogenic esophageal perforations after endoscopic procedures are potentially life-threatening events with a considerable mortality rate. The aim of this study was to demonstrate that a nonoperative endoscopic treatment with self-expanding metal stents may have a lower morbidity and mortality rate compared with surgical treatment.

METHODS: A nonrandomized observational study was conducted with 15 consecutive patients between January 1997 and June 2004. Benign spontaneous and iatrogenic esophageal perforations after endoscopic procedures were treated with self-expandable metal stents.

RESULTS: Seven patients (group 1) underwent stent insertion with an average time delay of 45 minutes. In 8 patients (group 2), the median delay was 123 hours. All patients in group 1 had an uneventful recovery and left hospital 5 days (range, 3 to 9) after stent insertion. One patient in group 2 (1 of 8) died of pneumonia after 6 days. In any other cases, perforations healed successfully after stent placement, but the clinical course was generally complicated with sepsis and multiple organ failure. The average hospital stay was 44 days (range, 15 to 70).

CONCLUSIONS: Immediate insertion of a self-expandable metal stent enables an excellent outcome with minimal mortality and morbidity without the need for operation. Even in cases of old esophageal perforations, sealing with self-expandable metal stents is still a good option although the clinical course is much less impressive than in early treated perforations.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Spontaneous or iatrogenic esophageal perforations after endoscopic procedures are, despite advances in modern surgery and intensive care medicine, still potentially life-threatening events with a considerable mortality rate (Table 1) [1–7]. Owing to a lack of a protective serosal surface, perforations of the esophagus can easily expand into the surrounding tissue, leading to mediastinitis and empyema of the pleural cavity [2, 8, 9].


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  		Table 1. Operative and Nonoperative Death After Benign and Malignant Esophageal Perforations
 
Until now, it has been controversial as to whether a nonoperative or a surgical treatment approach should be undertaken. The surgical procedure is, however, still the "gold standard" [2, 4, 8–12]. The main aims of the surgical treatment are rapid closure of the esophageal wall leak, drainage, and antibiotic treatment [8]. These aims can be achieved by simple oversewing of the perforation with additional extensive drainage ([2, 3], placement of patches [9–11], or total resection of the intrathoracic esophagus with a feeding gastrostomy and a cervical salivary fistula [3, 6, 13]. The reported mortalitiy rates using these surgical strategies are as high as 30% [2], and are related to the extent of resection [13] and the delay between the onset of esophageal perforation and the beginning of the surgical procedure [2, 8, 11, 14].

In contrast to the surgical approach, a nonoperative treatment regime was mainly used for patients unsuitable for surgery. In the past, conservative treatment was limited to antibiotics, insertion of a nasogastric tube, acid suppression, and nothing by mouth [7, 15]. The mortality rates reported for this strategy vary considerably (Table 1) [1–7], and hence it is still not widely accepted. Recently, encouraging results were reported about the sealing of esophageal perforations by insertion of an endoluminal prosthesis [1, 3, 16–19]. The majority of reported cases were tumor perforations, which were unsuitable for a surgical procedure, but there were also some treatment reports of nonmalignant perforations (Table 2) [16, 19–23].


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  		Table 2. Reports of Benign Esophageal Perforations Treated With Self-Expandable Metal Stents
 
The aim of this study was to demonstrate that the main principles of the surgical treatment, namely, the rapid closure of the esophageal leak and drainage, can also be achieved by minimal invasive endoscopic approach by inserting a covered metal stent, followed by interventional drainage.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
In this retrospective nonrandomized observational study, 15 consecutive patients with benign esophageal perforations were treated with a self-expandable metal stent (Ultraflex; Boston Scientific, Natick, Massachusetts; or Niti-S-Stent; Taewoong Medical, Seoul, Korea) between January 1997 and June 2004. Informed consent was obtained from all patients prior to treatment. The study cohort was divided into two groups with respect to the elapsed time interval between diagnosis and treatment.

The early treatment group (group 1) consisted of 7 patients in whom stent insertion took place within an average time delay of 45 minutes between diagnosis and the beginning of treatment. All perforations were iatrogenous and were diagnosed during the endoscopic procedure. Two of those perforations occurred in our own department, the other patients were transferred from outside.

The late treatment group (group 2) included 8 patients but the median delay of treatment was 123 hours. Five patients had a spontaneous perforation (Boerhaave's syndrome), 1 patient had a perforation after a laparoscopic fundoplication, and 2 patients each had a perforation after an esophageal diverticulectomy (Table 3).


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  		Table 3. Patient Characteristics
 
Perforations were confirmed by a water-soluble contrast swallow or contrast application with the endoscope if the perforation occured during the initial examination (Fig 1) If necessary, an additional computed tomography (CT) scan was performed.


Figure 1
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  		Fig 1. Esophageal perforation demonstrated by contrast application through the endoscope during the initial examination.

 
Endoscopic stent insertion was always performed under fluoroscopic control. The sealing of the perforation was then immediately confirmed by contrast application through the endoscope (Fig 2) and an additional CT scan with water-soluble contrast application. In all cases, wide-spectrum antibiotics were applied and a gastric tube was placed for the first 24 hours. All patients were given nothing by mouth for 24 hours after the endoscopic intervention. Thereafter, unlimited drinking of liquids and liquid food was allowed.


Figure 2
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  		Fig 2. Contrast application through the endoscope immediately after stent placement. The perforation is completely sealed.

 
If the stent crossed the lower esophageal sphincter in distal perforations for the entire treatment time, a high dose of proton pump inhibitors was administered to reduce gastroesophageal reflux.

Stent extraction was usually scheduled between day 10 and 8 weeks after perforation.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
In group 1, 6 of 7 patients could be discharged after an average hospital stay of 5 days. All patients were able to eat and drink normally, and no patient had a pleural empyema or signs of sepsis. Only 1 patient in group 1 had to be transferred to a general hospital for further rehabilitative treatment. Another patient needed an additional CT-guided abdominal drainage because of fluid accumulation close to the perforated esophagojejunostomy after bouginage. After application of an Ultraflex stent, complete sealing was confirmed in all cases after CT scan with water-soluble contrast swallow.

In group 2, the average hospital stay was 44 days, and the clinical course was generally complicated by sepsis and multiple organ failure (6 of 8 patients). Only 2 of these 8 patients could be discharged; all other patients were transferred to general hospitals for further rehabilitation. Seven of 8 patients had to be treated with chest tubes for pleural empyema. Two patients had an additional surgical procedure for wide drainage because the percutaneously placed drainage was insufficient and no clinical improvement was noted after 24 hours. In contrast to group 1, 2 patients with long existing perforations were treated with totally covered Niti-S stents; all other patients received the Ultraflex stent.

The follow up was nearly complete (14 of 15) as of August 2004. One patient died at home 3 weeks after discharge because of advanced gastric lymphoma. One patient died during the hospital stay because of pneumonia caused by aspiration on day 6 after stent placement (overall hospital mortality rate, 7%).

Overall, 12 stents were extracted without any technical problems after an average of 4 weeks (range, 10 days to 8 weeks). In all these cases, perforations healed well and remained sealed. Three stents were not extracted because, as mentioned, 2 patients died and 1 patient from group 2 was lost during the follow-up. Ten patients were able to swallow without any problem. The 2 patients who died were able to swallow with stent in place until death. Only 2 patients needed bouginage after stent extraction (2 and 7 times; Table 3).


   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
In the case of benign esophageal perforations, various suture and patch techniques [9–11], diversion, and even esophageal resection [3, 6, 13] have been employed, but the outcome after surgical therapy remains disappointing [2–5]. A well-known problem is the postoperative suture breakdown with consecutive anastomotic leaks. A 40% suture breakdown rate is reported in the case of nonbuttressed primary repair [10]. Suture breakdown can reach as high as 50% [24] if the repair is delayed beyond 24 hours. In cases of an underlying malignant disease, treatment of esophageal perforations with self-expanding covered stents has been described by several authors [1, 3, 16–18]. Although these patients were generally in a very bad condition and therefore unfit for major surgical procedures, the reported results were somewhat encouraging. Mason [14] placed endoluminal prosthesis during the surgical procedure to seal esophageal perforations. Segalin and coworkers [25] successfully treated 3 patients with benign esophageal perforations by endoscopic insertion of a tube. An equivalent effect could be achieved by an endoscopic insertion of a self-expanding coated metal stent; however, there are few case reports [16, 20–23]. Another study [19] reports a series of 11 patients receiving an expandable stent for treatment of esophageal perforation; however, treatment was performed late after perforation (median, 60 hours; range, 24 hours to 28 days). The data from these studies are summarized in Table 2.

Compared with these studies, our data are derived from the largest number of patients who have received treatment with self-expanding stents for benign esophageal perforations. Our reported mortality rate of 7% (1 of 15) is lower than the majority of other published treatment results (Table 1). This rate is possibly promoted by the flexible character of the stent itself and the continuously applied expansive pressure to the esophageal wall. These characteristics achieve a better sealing effect compared with rigid tubes, and also a devastating suture breakdown in highly compromised tissue can be avoided. Regarding prognostic factors for outcome after nonoperative treatment with self-expanding stents, the time interval between the onset of the perforation and the beginning of the intervention is the most important prognostic factor. As reported by others [2, 9, 11, 26], there is a strong correlation between the elapsed time between onset of esophageal perforation and treatment. With an increased delay between perforation and treatment, the prognosis worsens owing to the establishment of sepsis and progressive organ failure.

Based on this obvious clinical correlation, we note that the primary goal of any treatment of an esophageal perforation should be that the wall defect be sealed as soon as possible. In the case of an instrumental perforation, the stent should be inserted during the same procedure [16, 20, 22]. We recommend the Ultraflex stent in the case of an acute esophageal perforation because of its very fast and complete expansion. With this approach, the perforation can be sealed immediately, which consecuently prevents sepsis and organ failure because of minimal contamination of the mediastinum and pleural cavitiy. In case of an old esophageal perforation, a fast stent expansion is less vital because contamination has already taken place. Therefore, we recommend a totally covered Niti-S-Stent, which expands more slowly but could be easily extracted after weeks or even months. In old perforations with an extended wall defect and a contaminated pleural cavity, additional thoracoscopic irrigation and wide drainage might be advisable.

The prolonged clinical course of old perforations in our study might be related to a persisting poorly drained area of inflammation. Indeed, 2 of our patients in group 2 needed additional operative wide drainage. Percutaneously placed thoracic tubes alone might not be sufficient. It is difficult to determine the time point at which the perforation site is too contaminated for stent insertion treatment alone. None of our patients in group 1 (all treated within 1 hour) received a thoracic tube. There was only one CT-guided abdominal pigtail drainage of fluid accumulation after bouginage of an esophagojejunostomy. On the other hand, in group 2, 7 of 8 patients were treated initially with additional chest tubes for pleural empyema. Another 2 patients still needed operative wide drainage. In those cases, excessive contamination prevented primary healing. We believe that such patients would profit from primary additional thorascopic irrigation and drainage. In our department, we will change to this strategy in the future. If perforations are older than 12 hours and located in the distal part of the esophagus, we will try to place a transhiatal drainage by laparoscopic access close to the perforation site. In old Boerhaave's perforations with pleural empyema, a thoracoscopic irrigation will be performed in addition to the stent placement because the left pleura is often contaminated with food. A thoracic tube alone might be insufficient in those cases. We predict that patients with old contaminated perforation sites will benefit from this approach.

It should be noted that patients treated within the first 12 hours after perforation will only receive stent insertion and antibiotics without any additional drainage. Stent extraction after healing should always be performed because severe stent complications after long-stay treatment are well documented [27–30]. The exact period during which the stent should be in place for complete healing is still unknown. Segalin and coworkers [25] removed the tube after 2 to 3 weeks, whereas Dorman and associates [20] reported a period of 4 months for a self-expanding stent. Siersema and coworkers [19] retrieved stents after a median of 7 weeks after application. We recommend a period of 10 days for small esophageal perforations and as long as 8 weeks for extended esophageal wall defects. If the stent crosses the lower esophageal sphincter, early extraction is vital because there is a high risk of gastric acid reflux, which in the worst case may provoke aspiration pneumonia. In those cases, a high dose of proton pump inhibitors is necessary to reduce the amount of gastric succus. Completely covered stents are easy to extract even after months. Partially covered Ultraflex stents preferably should be removed within 4 weeks because the mucosa grows through the noncovered part, and extraction might cause a partial mucosectomy with bleeding and consecutive stenosis of the esophageal lumen. On the other hand, an advantage of partially covered stents is that the stent is less likely to migrate. In this series, no stent migration was observed.

Conclusion
The present study demonstrates that a minimal invasive treatment approach of a self-expandable metal stent insertion is a justified and safe method for sealing esophageal perforations. The demonstrated treatment results show an excellent outcome with a minimal mortality rate. Even in cases of old esophageal perforations, sealing with self-expandable metal stents achieves a good outcome in comparison with surgery, but the results are less impressive than for early treated patients. Additional thoracoscopic irrigation and drainage might be advisable if the stent is not inserted within the first hours. The most important prognostic factor for a beneficial outcome is the stent insertion as soon as possible. Any delay between perforation and definitive treatment impairs the prognosis. Stent removal after healing should always be performed and is not associated with increased morbidity or mortality.

Primary repair of esophageal perforations is still considered the "gold standard," but the encouraging results among early treated patients may be a fertile foundation for changing this paradigm, at least for patients treated early.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
We thank Dr Sandra Dieni from the Institute of Anatomy and Cell Biology of the Albert-Ludwigs-University Freiburg, Germany, for reviewing the manuscript as a native speaker.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

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