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Ann Thorac Surg 2008;86:436-440. doi:10.1016/j.athoracsur.2008.04.039
© 2008 The Society of Thoracic Surgeons
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Original Articles: General Thoracic

The Use of Self-Expanding Silicone Stents in Esophagectomy Strictures: Less Cost and More Efficiency

Robert C.G. Martin, MD*, Charles Woodall, MD, Ryan Duvall, BS, Charles R. Scoggins, MD

Department of Surgery, Division of Surgical Oncology, James Graham Brown Cancer Center, University of Louisville School of Medicine, Louisville, Kentucky

Accepted for publication April 14, 2008.

* Address correspondence to Dr Martin, 315 E Broadway, Rm 313l Louisville, KY 40202 (Email: robert.martin{at}louisville.edu).


Dr Martin discloses that he has a financial relationship with Boston Scientific Corp.

 

   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
Background: Benign and postoperative anastomotic esophageal strictures remain a common problem in the management of esophageal diseases and cancer. Repeated dilation remains the most common treatment algorithm. Esophageal stenting with a removable plastic stent is another option. This study evaluated the dysphagia effects and cost of removable silicone stents in the management of benign and postoperative anastomotic strictures compared with standard repeat dilation.

Methods: A matched case-control study was done of benign esophageal stricture treatments from July 2004 to August 2006 in all patients treated for benign esophageal strictures identified in a prospectively maintained esophageal database. Eighteen patients had a retrievable silicone-covered stent placed, and 24 were treated with standard repeated dilations without stents. Early esophageal stenting vs repeated dilation in esophagectomy strictures and other benign strictures was compared.

Results: The median number of dilatations was two (range, 1 to 3) for the 18 stent patients, with all stents placed for 3 months' duration, and four dilations (range, 2 to 12) in 24 patients treated solely with dilatation. An evaluation of median, high, and low total charges, net revenue, and direct margin demonstrated that the use of a removable stent after one failed dilation was more cost-efficient than repeated dilations.

Conclusions: In patients who do not respond to initial dilation, placement of removable esophageal stent at the second dilation leads to improved quality of life and dysphagia relief. Early use of a removable esophageal stent is significantly more cost-efficient when two or more esophageal dilations are avoided.

The anastomotic stricture rate in patients undergoing esophagogastrectomy has ranged from as low as 14% to as high 48% in multiple large studies throughout the world [1–3]. The common management for these anastomotic strictures, which predominantly occur in the first year of the postoperative course, is esophageal dilatation [4]. These patients commonly require a median of three dilatations, ranging from as low as one to as high as 14 in some patients [5]. At present, there are no predictive factors for the number of dilations that a patient will need for an esophagogastric anastomosis stricture. Similarly, there are no predictive factors for the number of dilations that are needed for different types of strictures, including reflux-induced, radiation-induced, or lye-ingestion strictures.

These repeated dilations do impact a patient's quality of life simply based on the time it takes to undergo this outpatient procedure, the potential adjuvant treatment interruption this may incur, and lastly, the overall expense that repeated outpatient endoscopies on a weekly or even biweekly occurrence can cause. Removable self-expanding silicone stents have been effectively used in the management of benign anastomotic strictures and may be a more efficient patient management algorithm in strictures that require repeated dilations [6–8]. Thus, the aim of this study was to evaluate the cost of patients undergoing repeated dilations vs patients undergoing early dilations and stenting in benign esophageal strictures.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
All patients undergoing endoscopy at the Louisville Medical Center from January 2004 to September 2006 were identified from the hospital database. At the Louisville Medical Center, the care of benign esophageal strictures is planned under the interventional endoscopists' discretion. During this time frame, the senior author used an early esophageal stenting treatment algorithm. This algorithm involved the use of a removable esophageal stent in all patients who required repeat dilation within a month from their initial dilation for any type of benign stricture. The patients were offered this option vs repeat dilation in the same technique as they had undergone before. This treatment algorithm was then compared with repeated dilations on other patients by other interventional endoscopists practicing in the same center. Only patients with dysphagia scores of 2 or greater were treated with dilation alone or with dilation and stenting [6, 9].

Data for these patients were then extracted from a prospectively maintained database for review under a protocol approved by the University of Louisville Institutional Review Board. Data examined included extensive demographics (age, sex, medical history, surgical history, social history, tobacco history, alcohol history, medication use, family history, and any other possible etiologic factors), pathology of esophageal cancer, dysphagia score [10], anatomy of stricture, including lumen size and diameter by barium esophagram, and outcome. Follow-up was obtained by the treating physician and is current from the end of the study.

All dilations and stent insertions occurred in the endoscopy suite with the use of intravenous sedation with midazolam and meperidine. Depending on the patient management and the diameter of the lesion, either a pediatric GIF PI40 endoscope or a diagnostic GIFQ180 endoscope (both Olympus America Inc, Center Valley, PA) was used for all procedures.

All patients treated with dilatation underwent balloon dilatation with a Controlled Radial Expansion Wireguided Balloon Dilator (Boston Scientific Inc, Microvasive, Natick, MA) to an appropriate diameter determined by postdilation endoscopic imaging and the degree of mucosal tearing.

Stent patients with narrow preoperative strictures and patients with benign anastomotic strictures underwent balloon dilatation with the Controlled Radial Expansion Wireguided Balloon Dilator to at least 16 mm of diameter before stent placement. Once this stricture was successfully traversed, a distal hemoclip (Resolution Clip, Boston Scientific) was placed 2 cm below the area of stricture or abnormality. The endoscope was then advanced farther, and a flexible Jagwire High Performance Guidewire (0.89 mm, Boston Scientific) was then placed into the second portion of the duodenum. The endoscope was then removed, leaving the Jagwire in place with a proximal hemoclip marking the proximal aspect of planned stent placement.

A retrievable silicone-covered stent (Polyflex, Boston Scientific; Fig 1A) was placed under continuous fluoroscopic guidance using the distal hemoclip as a guide. After successful placement of the stent, repeat endoscope was then performed to ensure proper placement as well as good apposition of the proximal flange to the esophageal mucosa (Fig 1B). A postprocedural roentgenogram was also used to establish baseline position of the stent (Fig 1C). Most stents were removed at 3 months, again under standard endoscopic sedation using a single nondisposable rat-toothed grasper.


Figure 1
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  		Fig 1. (A) The removable Polyflex silicone-covered esophageal stent. (B) Shown after endoscopic placement. (C) Fluoroscopic imaging.

 
Standard imaging studies based on the management problem in question were used to ensure placement as well successful treatment of the problem.

All total charges, costs, and reimbursements were reviewed from the hospital billing data on all patients included in this evaluation. These charges included all endoscopic therapy required to treat the patient's stricture.

The {chi}2 test, Student t test, and Mann-Whitney U test for nominal, continuous, and ordinal variables were used to evaluate the association of independent variables to surgical complications. Values of p < 0.05 were considered significant. Statistical analysis was performed using JMP software (SAS Institute Inc, Cary, NC).


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
During the study period, 18 patients (11 men, 7 women) presented with benign strictures, defined as postsurgical anastomotic strictures, radiation-induced strictures, reflux-induced strictures, and lye-ingestion strictures that failed an initial controlled radial expansion dilation within 1 month of the initial dilation and required retreatment. This retreatment involved repeat controlled radial expansion with the placement of a removable silicone stent (Fig 1). The median age for this group was 49 years (range 38 to 81 years; Table 1). Most of the strictures treated were anastomotic in nature, of either an esophagogastric anastomosis or an esophagojejunal anastomosis. The median time from operation to the identification of the stricture was 125 days (range, 67 to 174 days).


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  		Table 1 Demographics of Dilation Patients and Dilation and Stent Patient
 
This group underwent a median of two dilations (range, 1 to 3), with an overall improvement in their median dysphagia score from 2.3 at pretherapy to 1.2 at 8 hours after stent placement. All planned stent placements were successful. Stent migration occurred in 1 patient, 2 days after stent placement, which was retrieved without difficulty. A larger diameter stent was placed without problem and migration. One patient required a reintervention before stent removal because of a large food bolus that became impacted. The food bolus was removed, and the stent was left in place for the planned duration.

All stents are left for 3 months and are then removed with continued follow-up. Median and mean stent indwell time was 93 and 91 days, respectively. There were no other periprocedural or poststent placement complications. After a median follow-up of 15 months (range, 4 to 28 months), only 1 patient required reintervention related to an anastomotic recurrence of her cancer. All other patients remain without symptoms and have not required repeat endoscopic intervention.

In comparison, 24 patients (16 men, 8 women) underwent repeated controlled radial expansion dilation for similar benign strictures during this same time period. Their median age was 45 years (range, 33 to 77 years). There was an even distribution of anastomotic stricture types as in the dilation and stent group (Table 1). This group required a median of four dilations (range, 2 to 12). There was a less robust improvement in the median dysphagia score of patients undergoing dilation before and after therapy. After a median follow-up of 24 months (not significant comparison with stent group), 8 patients required subsequent reintervention with repeat dilation.

We then reviewed the total charges, direct costs, and insurance payments of all patients who underwent either controlled radial expansion dilation alone vs dilation and stenting. Table 2 outlines the median high and low costs of a single endoscopic procedure involving dilation alone compared with dilation and stent placement. In a review of median total charges, total direct costs, and insurance payments, the cost of an esophageal dilation and stenting is approximately twice of that of the cost of a dilation alone. This comparison is fairly consistent across the multiple costs seen, as presented in Table 2. Thus, if a single dilation endoscopic procedure can be spared, the cost of dilation and stenting is equivalent, and if more than one dilation can be spared, than early dilation and stenting becomes more cost efficient.


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  		Table 2 Charge, Direct Cost, and Payments for Dilation vs Dilation and Stent
 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
The endoscopic management of anastomotic strictures related to upper gastrointestinal operations [11], acid/alkali-induced strictures [12], and postradiation-induced strictures has been well established and optimized to involve some form of endoscopic dilation procedure, either with Savary-Gilliard or balloon dilators [12, 13]. Both dilation techniques have been found to be safe and efficacious but ultimately are operator-dependent based on the loose interpretation of how much dilation at one endoscopic procedure is enough; how often a patient should be reendoscoped and redilated, and what type of topical or injectable agents [14] have been found to be effective. With the advent of removable silicone [7] and even polytetrafluoroethylene [15] stenting, the use of esophageal stenting in the early management of benign esophageal strictures has become more widespread.

This report demonstrates the safety and efficacy of a more aggressive early esophageal stenting algorithm in patients whose initial dilation fails within 1 month after the procedure. This method led to significantly less numbers of median dilations, greater improvement in dysphagia scores, and overall cost-efficiency if more than one dilation could be spared. The other key to early dilation is the ability to maintain an appropriate diameter after dilation until the residual inflammatory stenoses has resolved or the stricture has stabilized to an acceptable diameter for the patient to swallow. Also important is to limit the frequency of travel that a patient must endure with repeated trips for repeated dilations.

The total reintervention rate because of recurrent dysphagia was 5% in our patient cohort. This is favorable comparison with other previous reports that had reintervention rates of 35.8% [9], 21.3% [16], 21.1% [8], and 25% [17], respectively, with the described use of self-expanding plastic stents. The low reintervention rate in our study can be explained by our use of a predominantly longer stent (120 or 150 mm) and wider stent (18 x 23 and 21 x 25 cm), which also corresponds to a marginal migration rate of 5% in our patients. We believe that leaving as much proximal esophageal mucosa opposing the silicone stent leads to an increase in stability of the stent, and also at least a 1.0- to 2.0-cm margin of migration that will not be clinically relevant. We have achieved these results by using both longer and larger-diameter silicone stents.

We do not believe that stent migration is a failure of the stent itself or related to the coating on the stent but is more related to the improper length and diameter that is used in certain clinical scenarios. Obtaining the maximum proximal normal esophageal apposition is one of the keys to successful stent placement and long-term fixation until the stricture resolves. We do not recommend the 16- x 19-mm stent or the 90-mm length stent for these specific reasons. However, the highest risk location for esophageal stent migration still remains in the cervical anastomotic stricture in which, at most, 2.0 cm of an upper stent margin can be placed so that it does not impact the upper esophageal sphincter, and thus, this location will always be a challenging stent migration location or not amenable to stenting. In that situation, repeated dilation would then be the optimal management for these types of patients.

We did not see any significant stent-related bleeding events or long-term issues with the stent in place for our minimum of 90 days. Our stent success rate was 100%, without any intraprocedural stent placement complications.

Key to the advantage of using early silicone esophageal stents compared with the self-expanding metal stents is that the stent can be removed and replaced easily by using the same system at the same procedure if, indeed, proximal or distal placement of the stent is not satisfactory [10]. In addition, structure and flexibility of the stent remains stable even after several months of stent therapy, the current longest reported case being 438 days with no clinical difference in stent flexibility [10].

These advantages on top of the potential cost-savings and quality of life improvement that can be administered to patients with benign esophageal strictures make early silicone esophageal stenting for benign esophageal strictures potentially more advantageous than repeated balloon or savory dilation.

Thus, in conclusion, self-expanding silicone stent placement offers an alternative to repeated dilation for benign esophageal strictures, with the potential improvement in quality of life related to dysphagia scores and cost-savings related to the reduction in the number of repeated dilations that are needed.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

  1. van Lanschot JJ, van Blankenstein M, Oei HY, Tilanus HW. Randomized comparison of prevertebral and retrosternal gastric tube reconstruction after resection of oesophageal carcinoma Br J Surg 1999;86:102-108.[Medline]
  2. Walther B, Johansson J, Johnsson F, Von Holstein CS, Zilling T. Cervical or thoracic anastomosis after esophageal resection and gastric tube reconstruction: a prospective randomized trial comparing sutured neck anastomosis with stapled intrathoracic anastomosis Ann Surg 2003;238:803-812.[Medline]
  3. Zieren HU, Muller JM, Pichlmaier H. Prospective randomized study of one- or two-layer anastomosis following oesophageal resection and cervical oesophagogastrostomy Br J Surg 1993;80:608-611.[Medline]
  4. Urschel JD, Urschel DM, Miller JD, Bennett WF, Young JE. A meta-analysis of randomized controlled trials of route of reconstruction after esophagectomy for cancer Am J Surg 2001;182:470-475.[Medline]
  5. Behzadi A, Nichols FC, Cassivi SD, Deschamps C, Allen MS, Pairolero PC. Esophagogastrectomy: the influence of stapled versus hand-sewn anastomosis on outcome J Gastrointest Surg 2005;9:1031-1040.[Medline]
  6. Ott C, Ratiu N, Endlicher E, Rath HC, Gelbmann CM, Scholmerich J, Kullmann F. Self-expanding Polyflex plastic stents in esophageal disease: various indications, complications, and outcomes Surg Endosc 2007;21:889-896.[Medline]
  7. Repici A, Conio M, De Angelis C, et al. Temporary placement of an expandable polyester silicone-covered stent for treatment of refractory benign esophageal strictures Gastrointest Endosc 2004;60:513-519.[Medline]
  8. Evrard S, Le Moine O, Lazaraki G, Dormann A, El Nakadi I, Devière J. Self-expanding plastic stents for benign esophageal lesions Gastrointest Endosc 2004;60:894-900.[Medline]
  9. Radecke K, Gerken G, Treichel U. Impact of a self-expanding, plastic esophageal stent on various esophageal stenoses, fistulas, and leakages: a single-center experience in 39 patients Gastrointest Endosc 2005;61:812-818.[Medline]
  10. Mellow MH, Pinkas H. Endoscopic therapy for esophageal carcinoma with Nd:YAG laser: prospective evaluation of efficacy, complications, and survival Gastrointest Endosc 1984;30:334-339.[Medline]
  11. Chang AC, Orringer MB. Management of the cervical esophagogastric anastomotic stricture Semin Thorac Cardiovasc Surg 2007;19:66-71.[Medline]
  12. Singhal S, Kar P. Management of acid- and alkali-induced esophageal strictures in 79 adults by endoscopic dilation: 8-years' experience in New Delhi Dysphagia 2007;22:130-134.[Medline]
  13. Cho YK, Shin JH, Kim BS, Yook JH, Song HY, Kim JH, Bae JI. Fluoroscopically guided balloon dilation of anastomotic strictures after total gastrectomy: long-term results AJR Am J Roentgenol 2007;188:647-651.[Abstract/Free Full Text]
  14. Rosseneu S, Afzal N, Yerushalmi B, et al. Topical application of mitomycin-C in oesophageal strictures J Pediatr Gastroenterol Nutr 2007;44:336-341.[Medline]
  15. Atabek C, Surer I, Demirbag S, Caliskan B, Ozturk H, Cetinkursun S. Increasing tendency in caustic esophageal burns and long-term polytetrafluoroethylene stenting in severe cases: 10 years experience J Pediatr Surg 2007;42:636-640.[Medline]
  16. Decker P, Lippler J, Decker D, Hirner A. Use of the Polyflex stent in the palliative therapy of esophageal carcinoma: results in 14 cases and review of the literature Surg Endosc 2001;15:1444-1447.[Medline]
  17. Costamagna G, Shah SK, Tringali A, Mutignani M, Perri V, Riccioni ME. Prospective evaluation of a new self-expanding plastic stent for inoperable esophageal strictures Surg Endosc 2003;17:891-895.[Medline]



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Ann. Thorac. Surg., August 1, 2008; 86(2): 440 - 440.
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