Clinical Experience With Montgomery Salivary Bypass Stents in the Esophagus

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1 Clinical Experience With Montgomery Salivary Bypass Stents in the Esophagus William H. Warren, MD, Claire Smith, MD, and L. Penfield Faber, MD Departments of Cardiovascular-Thoracic Surgery and Diagnostic Radiology, Rush Presbyterian-St. Luke's Medical Centre, Chicago, Illinois Thirty-seven patients with locally advanced malignancy (18, esophageal obstruction; 19, esophageal fistula formation) underwent attempted placement of a Montgomery salivary stent in the esophagus. This was unsuccessful in 3; in 2, because of inability to dilate, and, in 1, because of perforation. After dilation of the esophagus, there was no detectable underlying stricture in 11 patients; none of these patients experienced stent migration. Overall, there was 100% success in obliterating the fistulous tract, an 8.1% incidence of retrograde migration, no incidence of prograde migration, and no incidence of stent obstruction after discharge. Of the 34 patients with successfully placed stents, 27 were discharged from hospital, and were able to eat and drink without the need for intravenous supplementation or gastrostomy tube feedings. The survival in patients presenting with obstruction ranged from 1 to 13 months (mean, 8.0 months); the survival in patients presenting with a fistula ranged from 2 to 7 months (mean, 5.3 months). (Ann Thorac Surg 1994;57:1102-7) ne of the most challenging problems in esophageal 0 surgery is the management of patients with locally advanced, unresectable carcinoma of the esophagus. Therapeutic options in such patients include bypass operation, endoesophageal recanalization using BICAP electrocautery or neodymium:yttrium-aluminum-garnet photoablation, radiotherapy (external beam, brachytherapy, or both), and the placement of an esophageal stent. The purpose of this report is to summarize our clinical experience with the use of the Montgomery salivary stent placed entirely within the esophagus. Material and Methods Patients Since 1985, 37 patients with locally advanced and unresectable carcinoma have undergone attempted placement of a Montgomery salivary stent (E. Benson Hood Laboratories, Pembroke, MA) for treatment of a symptomatic esophageal obstruction, fistula formation, or both. In all cases, the tumors were considered unresectable based on clinical and radiologic findings. No patient was denied an attempted stent placement regardless of his or her general condition or anesthetic risk, the location and length of the tumor, and the tortuousity of the esophageal lumen. The sites of the primary malignancy were the esophagus (n = 20), lung (n = 14), larynx (n = 2), and breast (n = 1). Five of the carcinomas not primary to the esophagus caused obstruction by extrinsic compression without detectable involvement of the esophageal mucosa. In 31 patients, the tumor was in the upper third of the esophagus in 5, in the middle third in 21, and in the distal Presented at the Fortieth Annual Meeting of the Southern Thoracic Surgical Association, Panama City Beach, FL, Nov 4-6, Address reprint requests to Dr Warren, Suite 218, 1725 W Harrison St, Chicago, IL third but sparing the gastroesophageal junction in 5. Of the remaining 6 patients, 5 had undergone an esophiagogastrectomy and 1 had undergone a total gastrectomy; recurrent tumor developed at the anastomosis in all 6. Twenty-nine of the 37 patients had previously undergone chemotherapy or radiotherapy, or both, which initially had provided varying degrees of palliation. Patients presented with complaints referable to esophageall obstruction (n = 18), an esophagorespiratory fistula i(n = 16), a fistula between the esophagus and a right pneumonectomy space (n = 2), or a fistula to a subcarinal mediastinal abscess cavity (n = 1). A review of the perioperative complications, the length of hospital stay, the quality of life, and the length of survival was performed. Operative Technique Most procedures were performed with the patients under general anesthesia, although 2 patients had stent placement under sedation alone without intubation of' the airway. In patients with a known or suspected fistula to the respiratory tract, flexible bronchoscopy was performed initially. Retained secretions were aspirated, the site of the fistula was noted, and the endotracheal tube was placed beyond this point to minimize gastric bloating. Patients then underwent flexible esophagoscopy and the guidewire of an Eder-Puestow dilator was passed through the instrument channel into the stomach under fluoroscopic control. The esophagoscope was then withdrawn and the malignant stricture was dilated using Ilder- Puestow dilators. Whenever possible, the esophagus was further dilated using Maloney bougies until firm resistance was met. In 11 cases, no clinically detectable stricture remained at the completion of the dilation. The size of the stent (ranging from 8 to 20 mm outer diameter by The Society of Thoracic Surgeons /94/'$7.00

2 Ann Thorac Surg :!994; WARREN ET AL 1103 Fig 1. Montgomery salivary stents available in sizes ranging from 8 to 20 mm in outer diameter. [OD]) was selected based on the maximum dilatable diameter of the esophagus (Fig 1). The stent was passed using one of two techniques. In stents ranging from 10 to 14 mm OD, the stent was passed over a lubricated Maloney bougie and advanced into the esophagus such that the upper flange was below the level of the upper esophageal sphincter. At this level, the distal end of the stent almost always had passed beyond the stricture or fistula, and the Maloney bougie was withdrawn. The stent was then advanced farther using a rigid esophagoscope until it reached the desired position. In stents ranging from 16 to 20 mm OD, the stent was rnounted onto a flexible esophagoscope and advanced into the esophagus using a section of half-inch (1.25-cm) tubing that acted as a pusher (Fig 2). This silicone prosthesis is prone to tearing if grasped directly with foreign body forceps. If required, the stent can be repositioned more proximally using one or more Fogarty balloon catheters passed through the stent, which are then inflated and withdrawn, causing the stent to be pulled back. Results Of the 37 patients undergoing attempted stent placement, the stent could not be successfully placed in 3 patients, Fig 2. Method of insertion of stents of larger diameter. Under direct vbual control, the stent is advanced over the flexible esophagoscope using a length of Tygon tubing. Fig 3. A 16-mm Montgomery salivary stent placed through an esophagojejunostomy with recurrence of the carcinoma at the anastomosis (arrow). due to inability to dilate the stricture in 2 and due to intraoperative perforation of the esophagus in 1. Of the remaining 34 patients, all were extubated within 3 hours of the completion of the operation. On the first postoperative day, these patients underwent fluoroscopic examinations using barium sulfate contrast material. These studies demonstrated that the prosthesis had been successfully placed within the esophageal lumen through the strictured segment in all 15 patients presenting with obstruction. In all 19 patients presenting with a fistulous tract, the fistula had been successfully excluded. In 28 of the 34 cases in which the stent was successfully placed, the proximal flange was at least 1 cm below the upper esophageal sphincter and the distal tip was proximal to the gastroesophageal junction. In the remaining 6 cases, the stent was successfully placed across an anastomotic recurrence after a previous esophagogastrectomy (5 cases) or a total gastrectomy (1 case) (Fig 3). None of these 6 patients suffered symptomatic reflux. The degree of success in relieving dysphagia was related, in large part, to the diameter of the stent chosen. The diameters of the stents placed and the numbers of patients who received them were as follows: 8 mm, no patients; 10 mm, 3 patients; 12 mm, 4 patients; 14 mm, 5 patients; 16 mm, 10 patients; 18 mm, 9 patients; and 20 mm, 3 patients. Patients had no dietary restrictions, except to avoid apple and tomato skins and the pulp of fresh oranges. Patients were encouraged to eat as full a diet as they desired, including meat, provided it was chewed well. However, the patients with the smallest stents had the most advanced obstructions and sometimes had a limited appetite.

3 1104 WARREN ET AL No patients complained of tracheal irritation or esophageal discomfort, even though, in 7, the proximal flange of the stent was placed within 2 cm of the upper esophageal sphincter (Fig 4). In 11 patients (7 with fistula formation and 4 with obstruction), there was no evidence of an underlying stricture after dilation. In these patients, either 18-mm or 20-mm stents were placed (Fig 5). None of these 11 patients had evidence of stent regurgitation or migration and palliation was excellent in all. Four patients had regurgitation of the stent. In 3 of these cases, the dislodgment occurred within 48 hours of placement, and all were successfully managed by immediate reinsertion of a larger stent. Two of these 3 cases occurred early in our experience and arose because the stent inserted was too small for the dilated lumen. None of these 3 patients suffered any further displacement during the remainder of their survivals beyond 2, 3, and 13 months. The fourth patient had undergone an esophagogastrectomy, and suffered extrinsic compression from recurrent tumor at the site of the anastomosis, 2 cm below the upper esophageal sphincter. After the stent migrated distally on two occasions, the stent was removed and the stricture was allowed to redevelop. A 14-mm stent was successfully placed 7 months later, and, as of the last examination 11 weeks later, remained in a good position. One stent was passed inadvertently into the stomach at the time of the procedure and a gastrotomy was necessary to retrieve it. Once the stent was properly placed within the esophagus, there was no clinical evidence of prograde Ann Thorac Surg 1994;57l102-7 A B Fig 5. ( A ) Thin barium swallow study obtained in a patient after a right pneumonectomy demonstrating a tracheoesophageal fistula through a subcarinal mass to the left of the main bronchus (arrow). (B)Contrast-enhanced esophagogram demonstrating the 18-mm stent in place with obliteration of the fistulous tract. Fig 4. A 14-mm Montgomery salivary stent placed high in the cervical esophagus. Note that the flange is immediately below the upper esophageal sphincter. migration of the stent during follow-up until the patient died more than 6 months later. None of the 37 patients died intraoperatively or postoperatively in the hospital as a result of stent insertion. However, of the 34 Patients who successfullyunderwent stent placement, 6 patients died in the hospital from pulmonary sepsis 2 to 18 days after the procedure. The

4 Ann Thorac Surg 1994: WARREN ET AL 1105 remaining 28 patients were discharged from the hospital after a hospital stay ranging from 1 to 15 days (mean, 4.6 days) in patients with obstruction and from 1 to 36 days (mean, 7.7 days) in patients with a fistula. All discharged patients were able to eat and drink, and did not need intravenous support. In 2 patients, a gastrostomy tube had been placed before the stent insertion and was used temporarily to supplement oral intake. During a clinical follow-up until death, no patient experienced any postoperative esophageal obstruction, including impaction of the stent with food or collapse of the stent resulting from extrinsic compression. Follow-up contrast studies were not routinely obtained. Overall, 11 of 37 (29.7%) patients died within 30 days of stent placement. Of these, 4 of 18 (22.2%) patients originally presented with obstruction and 7 of 19 (36.8%) patients presented with a fistula. Of the 34 patients undergoing successful stent placement, survival in the 17 patients presenting with esophageal obstruction ranged from 1 to 13 months (mean, 8.0 months); 6 of these patients survived for more than 6 months. The survival in the 19 patients with a fistula ranged from 2 to 7 months (mean, 5.3 months); 3 of these patients survived for 6 months. In most cases, the cause of death was inanition, complicated by pulmonary sepsis. Two patients died of a sudden upper gastrointestinal hemorrhage 1 and 2 weeks after an apparently uncomplicated stent placement. Both of these patients had bulky subcarinal carcinomas with fistula formation. No autopsy was obtained. Comment In 1955, Montgomery [l] devised a polyethylene prosthetic tube to bridge the gap between the pharyngostoma and the esophagostoma after laryngoesophagectomy and before reconstruction of the cervical esophagus. These stents were molded in varying diameters to accommodate pharyngeal and esophageal lumina. Currently, these prostheses are commercially available as silicone tubes measuring 18 cm in length with an external diameter ranging from 8 to 20 mm. We and others [2] have chosen to place appropriately sized stents entirely within the esophagus using a "push-through" technique in patients with an unresectable malignant esophageal obstruction, fistula formation, or both. The lack of postoperative obstructions in our patients is in sharp contrast to the experience of others who have used other types of stents and who have reported an incidence of obstruction as high as 30% [3]. Tumors have not overgrown the ends of the Montgomery salivary stent, nor compressed the stents to cause a functional obstruction. In addition, choosing a stent that provides a maximal inner diameter and a smooth lining minimizes food sticking and impaction. These tubes are held in place by the residual underlying stricture (when one exists), the proximal flange, and the intrinsic tone of the esophagus. Furthermore, the upper and lower esophageal sphincters tend to prevent migration proximally and distally. We believe that the ability to choose an appropriately sized stent to distend the maximally dilated esophagus is largely responsible for the low incidence of migration in our patients, which others, using other stents, have reported to range from 3.8% to 23% [3-91. In those patients with little or no detectable underlying stricture, some authors consider stents to be contraindicated due to the high incidence of migration [6, 13, 151. Others have used tissue adhesive, Ivalon sponges, and inflatable balloons to minimize this risk [ With our technique, the stent did not migrate in any of the 11 patients without a clinically detectable stricture. Silicone is a soft and pliable polymer and the wall thickness in the Montgomery stent is 1 mm, which is less irritating to the trachea when the upper flange is in the subcricoid area. The pliability of the silicone and the availability of the stent in varying diameters facilitate insertion, even when the esophageal lumen is markedly narrowed or tortuous. We had only a 5.4% (2 of 37) incidence of failure to intubate due to inability to pass the stent down a tortuous or narrowed esophagus; others have reported an incidence as high as 9.4% using other stent models [4]. In 4 patients in our series, Montgomery salivary stents were successfully placed after attempts to place other models had failed. In addition, we have noted a low incidence of failure to exclude a fistula, which others have reported to be as high as 26.5% [12, 191, and a low incidence of perforation, which others have reported to be as high as 18% using Keymed-Atkinson stents [3, 14, 201. The 30-day perioperative mortality reflects the poor health of patients who undergo these procedures. Our perioperative mortality and mean survival compare favorably with those reported for other series [2, 4, 51. In conclusion, we believe that the Montgomery-Hood salivary stent can be safely introduced into the esophagus with an attendant low operative mortality and an acceptably low complication rate. It produces reasonable palliation and also offers patients who otherwise live in misery an opportunity for survival beyond 6 months out of the hospital. This stent deserves further study, especially because it has been highly successful in excluding fistulous tracts, and in palliating patients with no underlying stricture in whom other esophageal prostheses traditionally have been contraindicated. Supported in part by the John and June Antalek Foundation, the Kole Foundation, and the contributors to the Thoracic Disease Research Fund. References 1. Montgomery WW. Plastic esophageal tube. Ann Otol Rhino1 Laryngol 1955;64: Richter JM, Hilgenberg AD, Christensen MR, et al. Endoscopic palliation of obstructive esophagogastric malignancy. Gastrointest Endosc 1988;34: Liakakos TK, Ohri SK, Townsend ER, Fountain SW. Palliative intubation for dysphagia in patients with carcinoma of the esophagus. Ann Thorac Surg 1992;53:46&3. 4. Buset M, des Marez B, Baize M, et al. Palliative endoscopic management of obstructive esophagogastric cancer: laser or prosthesis? Gastrointest Endosc 1987;33:

5 1106 WARREN ET AL Ann Thorac!Surg 1994; Alderson D, Wright PD. Laser recanalization versus endoscopic intubation in the palliation of malignant dysphagia. Br J Surg 1990;77: Angorn IB. Intubation in the treatment of carcinoma of the esophagus. World J Surg 1981;5: Segalin A, Little AG, Ruol A, et al. Surgical and endoscopic palliation of esophageal carcinoma. Ann Thorac Surg 1989; 48: den Hartog Jager FCA, Bartelsman JFWM, Tytgat GNJ. Palliative treatment of obstructing esophagogastric malignancy by positioning of a plastic prosthesis. Gastroenterology 1979; Girardet RE, Ransdell HT, Wheat MW. Palliative intubation in the management of esophageal carcinoma. Ann Thorac Surg 1974;18: Watson A. A study in the quality and duration of survival following resection, endoscopic intubation and surgical intubation in oesophageal carcinoma. Br J Surg 1982;69: Mason RC, Bright N, McColl I. Palliation of malignant dysphagia with laser therapy: predictability of results. Br J Surg 1991;78: Cusumano A, Ruol A, Segalin A, et al. Push-through intubation: effective palliation in 409 patients with cancer of the esophagus and cardia. Ann Thorac Surg 1992;53: Hegarty MM, Angorn IB, Bryer JV, Henderson BJ, LeRoux BT, Logan A. Pulsion intubation for palliation of carcinoma of the oesophagus. Br J Surg 1977;64:16G Chisholm RJ, Stoller JL, Carpenter CM, Burhenne HJ. Rasdiologic dilatation preceding palliative surgical tube placement for esophageal cancer. Am J Surg 1986;151: Burt M, Diehl W, Martini N, et al. Malignant esophagorespiratory fistula: management options and survival. Ann Thorac Surg 1991;52: Straumann A, Gyr K, Stalder GA. Occlusion of a malignant oesophago-bronchial fistula with an adhesive anchored endoprosthesis. Schweiz Rundsch Med Prax 1984;73: Robertson CS, Atkinson M. A modified prosthetic oesophageal tube to manage malignant oesophago-respiratory fistula. Lancet 1986;2: Irving JD, Simson JNL. A new cuffed oesophageal prosthesis for the management of malignant oesophago-respiratory fistula. Ann Coll Surg Engl 1988;70: Wang P-Y, Yeh T-J, Chen C-L, Chen C-Y. A spiral-grooved endoesophageal tube for management of malignant esophageal obstruction. Ann Thorac Surg 1985;39:50? Hine KL, Atkinson M. The diagnosis and management of perforations of esophagus and pharynx sustained during intubation of neoplastic esophageal strictures. Dig Dis Sci 1986:31: DISCUSSION DR KAMAL A. MANSOUR (Atlanta, GA): This is a good report in the field of palliation of unresectable carcinoma of the esophagus with or without tracheobronchial invasion. With the 4.5% mortality, 8% obstruction, 9% perforation, and 10% dislodgment reported for other plastic tubes, one is happy to welcome the Montgomery stent described by Dr Warren and his group today. He reported no intraoperative mortality in his experience with 37 patients, excellent relief of obstruction in all 15 such patients, and successful exclusion of esophagorespiratory fistula in all 19 affected patients. I agree with the use of the Montgomery endoesophageal stent in patients with primary unresectable lesions of the esophagus, as the proximal flange of the silicone tube sits on the ragged, irregular edge of the tumor. However, in patients with esophageal strictures caused by extrinsic compression from metastatic lung or breast carcinoma, presumably due to subcarinal node invasion, one wonders what prevents the tube from dislodgment. I also agree with its use in midesophageal lesions; however, for lesions at the distal end, particularly those fixed, unresectable lesions at the gastroesophageal junction, I believe a bypass procedure is preferable, as the tube would angulate because of the axis of the tumor at this location. Through a left thoracotomy, the esophagus is cut above the tumor, then the gastric fundus is brought through the enlarged hiatus and anastomosed to the esophagus. Finally, I have two questions for Dr Warren. First, you performed an esophagogastrectomy on the patient who sustained intraoperative perforation of the esophagus at the time of placement of the stent. Why did you not do that in the first place, as the lesion was evidently resectable to begin with? The second question is: how did you know that the stent was not responsible for the fatal upper gastrointestinal bleeding that occurred in the 2 patients 1 and 2 weeks postoperatively? DR DANIEL L. MILLER (Rochester, MN): I congratulate Dr Warren on his excellent results in an unfortunate group of patients. I have two questions. First, what treatments were used in the 2 patients whose stent placements were unsuccessful? And second, did any of the patients experience respiratory problems after stent placement, and, if so, what was done for them? DR WILLIAM A. COOK (North Andover, MA): There are two other types of esophageal stents available that have not been mentioned, both of which have very useful applications. One is the Wilson-Savary, which is a system that can be placed over a guidewire. In those patients who have very tight strictures, that can be most helpful. Then, of course, there is the grandfather of most of these, and that is the Fell tube, which is designed to be sutured to the wall of the stomach so that it cannot be displaced. One of the problems that exists with the intraesophageal tubes is that, if they go into the stomach, reflux can occur through them and be a troublesome complication. We have found over the years that the end of these tubes can be cut with a V on each!side so that it creates a "fish mouth" at the end of the tubing. This flap will close, more or less like a Heimlich valve closes, and prevent most of the reflux that occurs. Finally, with this Hood-type stent we have found that, even when they do displace, if there is a big enough lumen to reach the stent itself, because of the thinness of the stent wall, you can told up that upper flange and literally back it up to the position where you originally wanted to have it. DR WARREN: I thank the discussants for their thoughtful questions. One of the potential problems with placing these stents across the gastroesophageal junction is reflux. In this series, the stents only bridged this junction in 5 patients who had undergone an esophagogastrectomy previously. None of these patients was troubled by reflux, but this may be a problem in patients who have not undergone a previous resection. In that setting, a Penrose drain can be sutured to the end of the stent to act as a flap, much like a Heimlich valve on a chest tube. Doctor Doug Mathisen told me that he has used that technique with success. Doctor Mansour described a technique to bypass tumors at the gastroesophageal junction as an alternative to stent placement.

6 Ann Thorac Surg 1994;57: WARREN ET AL 1107 SALIVARY STEWS IN THE ESOPHAGUS Our experience with stents in these cases is limited to those 5 patients who had previously undergone an esophagogastrectomy and suffered an anastornotic recurrence. I do not believe that the technique of rolling the fundus up would be applicable in these patients. Doctor Miller, those 2 patients in whom we were unable to place a stent died shortly after the procedure and were not candidates for any other procedure, including laser esophagoscopy. They had very tight strictures resulting from previous irradiation and were very cachectic. I have tried performing laser esophagoscopy as an alternative to stent placement, but I believe that we can achieve faster and longer-lasting palliation by stenting rather photoablating these tumors. The patient who was perforated was 86 years old and led a bed-to-chair existence. He had an extensive tumor of the distal third of the esophagus, which was initially considered unresectable. It was the patient s and his family s wish to avoid major surgery, if possible. Upon performing exploration for the perforation, we were surprised to be able to carry out an esophagogastrectomy. After a stormy postoperative course, he was, in fact, discharged to a nursing home, where he died shortly thereafter. We were unable to get an autopsy to determine the cause of death. The Society of Thoracic Surgeons: Thirty-first Annual Meeting Mark your calendars for the Thirty-first Annual Meeting of The Society of Thoracic Surgeons, which will be held at the Palm Springs Convention Center in Palm Springs, California, January 30-February 1, Members may register for the Scientific Sessions at no charge. There will be a $250 registration fee for nonmember physicians except for Scientific and Poster Session presenters and residents. Registration for the Postgraduate Course is separate from the Annual Meeting. There will be a $65 registration fee for attendees of the Postgraduate Program, which will be held Sunday, January 29. The Postgraduate Course will provide in-depth coverage of thoracic surgical topics selected to enhance and broaden the knowledge of practicing thoracic and cardiac surgeons. Advance registration forms, hotel reservation forms, and details regarding transportation arrangements, as well as the complete meeting program, will be mailed to Society members this fall (1994). Nonmembers wishing to receive information on attending the meeting should write to the Society s Secretary, Richard P. Anderson. Richard P. Anderson, MD Secreta y The Society of Thoracic Surgeons 401 N Michigan Ave Chicago, IL (312)

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