(Radiology. 1999;210:865-870.)
© RSNA, 1999
Upper Gastrointestinal Tract Malignant Obstruction: Initial Results of Palliation with a Flexible Covered Stent
Hong Suk Park, MD1,
Young Soo Do, MD1,
Soo Won Suh, PhD4,
Sung Wook Choo, MD1,
Hyo Keun Lim, MD1,
Seung Hoon Kim, MD1,
Young Mog Shim, MD2,
Keun Chil Park, MD3 and
In Wook Choo, MD1
1 Departments of Radiology (H.S.P., Y.S.D., S.W.C., H.K.L., S.H.K., I.W.C.)
2 Thoracic Surgery (Y.M.S.)
3 Internal Medicine (K.C.P.), College of Medicine, Sungkyunkwan University, Samsung Medical Center, 50 Irwon-dong, Kangnam-ku, Seoul 135-710, Korea
4 Samsung Biomedical Research Institute, Seoul, Korea (S.W.S.).
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Abstract
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The authors treated 21 patients with inoperable upper gastrointestinal tract malignant obstruction from the esophagus to the duodenum by means of intubation with a flexible covered stent with fluoroscopic guidance. Stent placement was successful and relief of dysphagia was immediate in 18 (86%) patients, without serious complication. The average dysphagia score decreased from 2.6 (dysphagia to liquids) to 1.0 (dysphagia to normal solid food). Placement of a flexible covered stent provides easy, safe, and effective palliation of upper gastrointestinal malignant obstruction.
Index terms: Duodenum, stenosis or obstruction, 73.74 • Esophagus, grafts and prostheses, 71.1269, 71.74 • Esophagus, interventional procedure, 71.1269 • Esophagus, neoplasms, 71.32 • Esophagus, stenosis or obstruction, 71.74 • Gastrointestinal tract, interventional procedure, 71.1269 • Stomach, stenosis or obstruction, 72.143, 72.74
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Introduction
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Covered or uncovered self-expanding metallic stents have been proved to be an easy, safe, and effective device for palliation of esophageal malignant obstruction and esophagorespiratory fistula (1–13). Owing to their relative lack of longitudinal flexibility, the stents could not bend easily to fit around a curvature (2,11). The stent ends would abut the wall of the gut and either migrate (13) or get stuck against the wall. Thus, primary patency cannot be achieved in angled bowel, such as in the esophagogastric junction or an esophagojejunostomy site, and it was difficult to insert a stent into the upper gastrointestinal tract distal to the gastric outlet. In recent years, some authors have reported favorable results of treatment of gastric and duodenal obstruction by placing covered or noncovered self-expanding metallic stents (14–16). However, the patients required gastrostomy when a covered stent was used (15), and there was the risk of tumor ingrowth when a noncovered stent was used (7,11,12,17).
To overcome these problems and to extend use of stent insertion to treat upper gastrointestinal tract obstruction distal to the stomach, we designed and constructed a flexible covered stent and used it to treat inoperable upper gastrointestinal malignant obstruction from the esophagus to the duodenum. The purpose of this study was to assess the effectiveness and outcome of palliative treatment with flexible covered stents.
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Materials and Methods
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Patients
From May 1996 through August 1997, we treated disease in 21 patients with inoperable esophageal, gastric, duodenal and postoperative esophagogastric, gastrojejunal, or esophagojejunal malignant obstruction and esophagorespiratory fistula by placing a flexible covered stent (Table). There were 17 men and four women, aged 41–77 years (mean age, 61 years). The histologic diagnosis was made on the basis of findings at previous endoscopy or bronchoscopy in all but one patient, who had pancreatic cancer. The diagnosis of upper gastrointestinal malignant obstruction was made on the basis of the patient's clinical history and was confirmed with single or double contrast barium study, computed tomography, or endoscopy. Disease in all patients was inoperable because of tumor extension, distant metastasis, debilitating condition, or advanced age.
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Treatment of Upper Gastrointestinal Malignant Obstruction with a Flexible Covered Stent: Clinical Data and Treatment Outcome
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Among the 21 patients, seven had esophageal squamous cell carcinoma, seven had recurrent gastric carcinoma after subtotal or total gastrectomy, three had advanced gastric carcinoma, one had pancreatic cancer invading and causing obstruction of the second portion of the duodenum, and three had esophagorespiratory fistulas (one had esophageal cancer; one, lung cancer; one, adenoid cystic carcinoma of the trachea). In the seven patients with esophageal cancer, disease was inoperable due to the presence of extensive invasion and metastasis. In the seven patients who had undergone total or subtotal gastrectomy for gastric cancer, three had obstruction of esophagojejunostomy sites, two of gastrojejunostomy sites (one also of the afferent loop), and two of the esophagogastric junction. Among the three patients with gastric cancer, one had disease that was inoperable because of her advanced age, and two had diffuse liver metastasis, which in one involved the second portion of the duodenum. Among the three patients with esophagorespiratory fistula, each had a history of irradiation and symptoms of aspiration during food intake.
Patient dysphagia was graded on a scale of 0–4 both before and after stent placement: 0, no dysphagia; 1, dysphagia to normal solid food; 2, dysphagia to soft food; 3, dysphagia to liquids; and 4, inability to swallow saliva. The average grade of dysphagia was 2.6 in these patients.
Informed consent was obtained from each patient prior to stent placement. The study protocol was approved by our hospital ethics committee.
Patients were evaluated immediately after stent placement and every month thereafter. Progressive change in diet was recommended after stent placement. Patients ingested fluids immediately after the procedure and were kept on a soft diet for 2 days then advanced to a solid diet. Patients were phoned every month and asked what they ate and if there was any pain and discomfort. We recommended that patients undergo barium study at monthly intervals, if possible.
Stent Construction
Each stent consisted of three parts: body (middle portion of the stent), proximal, and distal. The body of the stent was constructed of 0.4-mm stainless steel wire in a cylindric zigzag fashion of 12 or 15 bends, 16 or 18 mm in diameter and 10 mm long. Two to nine stents were connected to make the body. The proximal and distal parts were constructed of 0.3-mm stainless steel wire in a cylindric zigzag fashion consisting of 12 bends. The proximal and distal parts were 6 mm larger in diameter than the body of the stent and were 2 cm long. We connected the proximal and distal parts to the body of the stent at right angles by using three metallic struts.
The stent was covered with polyurethane, with 3-mm gaps between each metallic stent body part, to give longitudinal flexibility (Fig 1). A 15% pellethane (2363-80AE; Dow Chemical, Midland, Mich) solution dissolved in N, N-dimethylacrylamide was used as the polyurethane solution. The stent was covered by using a dip-coating technique within an anaerobic glove box with clean room conditions. Several bends of metal wires on a stent mold were dipped into the polyurethane solution, with great care to avoid trapping of air bubbles, and dried at 40°C for 24 hours in a drying oven. The stents were handmade in our research laboratory. According to the manufacturer of stents that are commercially available today (Choo Stent; Solco Intermed, Seoul, Korea), they do not differ from the stents we designed.
We used an introducing tube made of polytetrafluoroethylene, with an outer diameter of 6 or 7 mm, and a pusher catheter made of polyurethane. The delivery system was composed of a guiding tip, a guiding tube, an introducing tube, a pusher catheter, and a compressed stent (Fig 2).
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Figure 2. Photograph shows the flexible covered stent and the entire stent assembly, which consists of a guiding tip (short arrow), introducing tube (long arrow), guiding tube (inside the assembly and, therefore, not visible), pusher catheter (arrowheads), and a compressed stent. The ruler indicates centimeters.
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Stent Placement
Pharyngeal anesthesia was routinely provided with lidocaine aerosol spray (Xylocaine 10% spray; Astra, Linz, Austria) before the procedure. With fluoroscopic guidance, a 5-F angiographic catheter and a 145-cm-long, 0.035-inch-diameter hydrophilic guide wire (Radiofocus M; Terumo, Tokyo, Japan) were inserted and passed through the stenotic segment. In two patients with obstruction distal to the stomach, use of a 7-F guiding catheter was also necessary.
After an angiographic catheter was advanced across the stricture, the guide wire was removed and a barium study was obtained with barium suspension to help correct localization of the lesion and measurement of the stenotic segment. Then, a 0.038-inch guide wire (Amplatz Superstiff; Medi-tech/Boston Scientific, Watertown, Mass) was introduced into the stomach in the case of esophageal obstruction and into the third portion of the duodenum in the case of gastric antral or duodenal obstruction.
A flexible covered stent 4 cm longer than the stricture was selected, so that the proximal and distal parts of the stent rested on the proximal and distal margins of the stricture, and placed into a delivery system. After being lubricated with jelly, the delivery system was advanced over the guide wire and properly positioned across the stricture with fluoroscopic guidance. The introducing tube was withdrawn while the pusher catheter was held in place. This maneuver released the stent and allowed it to expand within the stricture. After the stent was deployed, the delivery system and guide wire were removed and a barium study was obtained in supine and erect positions to verify the position and patency of the stent.
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Results
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Placement was successful in 18 of 21 patients, with 19 stents (Figs 3–6). Two stents were placed in a patient with afferent and efferent loop obstructions after subtotal gastrectomy (Fig 4). Among the remaining three patients, two had obstruction in an anastomotic site, after gastrectomy due to gastric cancer, and it was impossible to pass the guide wire through the obstruction. The remaining patient had advanced pancreatic cancer causing obstruction in the third portion of the duodenum, and delivery of the stent was successful to the second but not the third portion of the duodenum.
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Figure 3a. Patient 10. (a) Esophagogram shows esophageal cancer (arrows) involving the distal esophagus. (b) Esophagogram obtained immediately after stent placement shows relief of the obstruction. Note flexibility of the stent.
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Figure 3b. Patient 10. (a) Esophagogram shows esophageal cancer (arrows) involving the distal esophagus. (b) Esophagogram obtained immediately after stent placement shows relief of the obstruction. Note flexibility of the stent.
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Figure 6a. Patient 20. (a) Initial barium study shows obstruction (arrows) extending from the pylorus to the proximal second portion of the duodenum. (b) Barium study obtained after insertion of a stent (arrows) shows relief of the obstruction.
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Figure 6b. Patient 20. (a) Initial barium study shows obstruction (arrows) extending from the pylorus to the proximal second portion of the duodenum. (b) Barium study obtained after insertion of a stent (arrows) shows relief of the obstruction.
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Figure 4a. Patient 18. (a) Initial barium study shows obstruction (arrows) of the afferent (A) and efferent (E) loops. (b) Barium study obtained after insertion of a stent in each loop shows relief of the obstruction. Note flexibility of the stent (arrow) in the afferent loop.
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Figure 4b. Patient 18. (a) Initial barium study shows obstruction (arrows) of the afferent (A) and efferent (E) loops. (b) Barium study obtained after insertion of a stent in each loop shows relief of the obstruction. Note flexibility of the stent (arrow) in the afferent loop.
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Results of a barium study obtained immediately after stent placement demonstrated luminal patency with good flow of barium in all successful cases. In three cases of fistula, the fistulas became occluded immediately after stent placement, and aspiration and fever were improved. No complication occurred during the procedure. Mild reflux occurred in two of three patients in whom the stent straddled the gastroesophageal junction, and they were advised to sleep in a semierect position to minimize reflux and aspiration of the gastric contents. Technical difficulty was encountered in the two cases of a gastric antral lesion and in one case of a duodenal lesion (Figs 5, 6). In these cases, much more force was needed to deliver and deploy the stent than was necessary in the cases of esophageal obstruction, and 1 mg of midazolam hydrochloride, 25 µg of fentanyl citrate, or both was injected intravenously for pain relief.
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Figure 5a. Patient 13. (a) Barium study obtained after insertion of an angiographic catheter into the stomach shows obstruction of the pyloric antrum (arrows). (b) Follow-up double contrast barium study obtained 3 months after stent placement shows patency of the stent (arrows).
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Figure 5b. Patient 13. (a) Barium study obtained after insertion of an angiographic catheter into the stomach shows obstruction of the pyloric antrum (arrows). (b) Follow-up double contrast barium study obtained 3 months after stent placement shows patency of the stent (arrows).
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The average dysphagia score decreased from 2.6 to 1.0 within 1 week after stent placement. Six patients felt mild chest pain and discomfort for 1–3 days. A follow-up study (average, 8 weeks) was available in 11 patients with a chest radiograph and in four patients with a barium study. In each of those studies, the stent was seen to be in place, without migration, and patent. Early in the trial, patients did not undergo follow-up studies or visit the hospital after stent placement because stent placement occurred during the terminal phase of illness.
Thirteen patients died (four of diffuse metastases, two of distal obstruction, two of cachexia, two of pneumonia, one of hemoptysis, and two of unknown cause) 1–24 weeks (mean, 10.3 weeks) after stent placement. Five patients were alive with patent stents as of December 1997, when the stents had been in place for 9–30 weeks (mean, 19.2 weeks).
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Discussion
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Obstruction causing dysphagia, vomiting, and finally starvation is a cause of death not only in patients with esophageal malignancy, but also in patients with gastric or duodenal malignant obstruction. In about 58% of patients with esophageal cancer (18) and 40% of patients with gastric cancer (14), curative resection is not feasible and palliative anastomotic surgery is the usual option. However, such palliation is not always feasible, and the surgical mortality rate is reported to be 5%–60% in esophageal cancer (7,19) and 22.2% in gastric cancer (20). Even after palliative resection of the tumor, fibrotic stricture causing dysphagia occurred in about 20% of patients with esophageal cancer (1), and symptoms were relieved in only 29% of patients with gastric cancer (21).
Esophageal malignant obstruction is palliated effectively and easily with covered, metallic stents. According to some reports, however, complications such as chest pain, blockage, gastroesophageal reflux, migration, perforation, and delayed massive bleeding occur in about 40%–53% of the patients (4,5,13). In addition to these problems, there were failures due to angulation or migration of the stent or abutment on the bowel wall in an angled lesion (2,11,13). Patients experience pain and discomfort when the stent passes through the oropharynx, and it is impossible to insert a stent in patients with an obstruction distal to the stomach. Binkert et al (16) reported favorable results of palliation of gastric and duodenal obstruction with a noncovered Wallstent (Schneider, Minneapolis, Minn) for vascular use. However, correct placement of a noncovered Wallstent is rather difficult due to its shortening, and some authors reported migration in 3%–5% and perforation or massive bleeding in 11% of cases of esophageal obstruction (11,17). Use of a noncovered stent is also accompanied by a risk of tumor ingrowth (7,11,12,17).
The flexible covered stent has several advantages over other covered metallic stents. The flexible covered stent is much easier to insert and causes much less pain and discomfort during implantation. There is no need for dilation with a balloon catheter prior to stent placement. The stent can be accurately placed and patent in an angled bowel. The key to the flexibility and patency of the stent is the 3-mm gap between each stent body part that is made of only polyurethane membrane without metallic mesh. This is the most important difference between the flexible covered stent and the conventional stent. In a comparison of our flexible covered stent with 3.5-mm gaps and the modified Gianturco stent (Solco Intermed) of identical diameter (18 mm) and length (12 cm), the reduction rates for the internal diameter were about 5% at 180° flexion in the former and 85% at 30° flexion in the latter (unpublished data). Most of all, the flexible covered stent can be placed in the gastric antrum and duodenum. The most distal portion where the stent could be placed was the proximal second portion of the duodenum.
To our knowledge, ours is the first report of peroral intubation of the duodenum with a covered metallic stent. We previously reported favorable results of treatment of colorectal malignant obstruction with the flexible covered stent (22). In the current study, placement of the stent allowed preoperative decompression of the colon in operable cases and effective palliation in inoperable cases. The flexible covered stent can be delivered in a compressed and flexible form by using a flexible introducing tube with small diameter. Friction between the polyurethane covering and the introducing tube, which is made of polytetrafluoroethylene, is lower than that between other materials, such as silicone rubber and polyethylene or polytetrafluoroethylene (23–25). This low friction is not important in cases of esophageal intubation, but it is important in deployment of a stent in a case of distal upper gastrointestinal obstruction, such as in the pylorus or duodenum. In some of our cases in which the obstruction was not so severe, the stent showed flexion, elongation, constriction, and expansion at fluoroscopy in correspondence to peristaltic waves. This phenomenon can explain why no migration was seen at follow-up and why the rate of other complications was low. In a study of conventional covered metallic stents connected by metallic struts, the stents acted as a single tube during peristaltic waves and therefore migrated in four of 27 patients or caused trauma in the esophagus in two patients (8).
Polyurethane is very elastic and strong. Miyayama et al (8) reported the reliability of a polyurethane covering for a metallic stent, with results confirmed at follow-up endoscopy. Although there was no disruption of the covering in our study, we were not certain of its durability, because our stent has no metallic supports in the gaps between each stent body part, as do other polyurethane-covered stents. In our last three cases, we reinforced the covering by means of repeated coating and drying of polyurethane.
During this study, we encountered two major technical problems with stent placement. First, two major obstacles exist when the stent is inserted in an obstruction distal to the stomach: the distal portion of the gastric greater curvature and the transition area between the first and second loops of the duodenum. Much more effort and time were needed to pass the wire and deliver and deploy the stent than was necessary for esophageal intubation. This problem can be solved if the material of the introducing tube is replaced with a material that is much more flexible than polytetrafluoroethylene. The second technical problem is reflux of gastric contents when the stent is inserted in an esophagogastric obstruction. We are currently testing a stent designed with an antireflux valve.
Although further clinical trial and follow-up studies are needed, our preliminary findings suggest that not only esophageal obstruction but also gastric pyloric and duodenal malignant obstruction could be successfully palliated with the flexible covered stent.
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Acknowledgments
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We thank Siunna Baek, MA, for reviewing the manuscript and Eun Kyung Bae, BA, for obtaining patient follow-up information.
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Footnotes
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Address reprint requests to Y.S.D.
Author contributions: Guarantors of integrity of entire study, I.W.C., Y.S.D.; study concepts, Y.S.D.; study design, Y.S.D., H.S.P.; definition of intellectual content, H.S.P.; literature research, H.S.P.; clinical studies, H.S.P., Y.S.D., S.W.C., H.K.L., S.H.K, Y.M.S., K.C.P., I.W.C.; experimental studies, Y.S.D., S.W.S.; data acquisition and analysis, H.S.P.; manuscript preparation and editing, H.S.P.; manuscript review, Y.S.D.
Received March 24, 1998;
revision requested June 17, 1998; revision received July 24, 1998;
accepted October 20, 1998.
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Abstract
Introduction
