Self-expandable metallic stents in the palliation of rectosigmoidal carcinoma: a follow-up study

Self-expandable metallic stents in the palliation of rectosigmoidal carcinoma: a follow-up study

Self-expandable metallic stents in the palliation of rectosigmoidal carcinoma: a follow-up study Jan Tack, MD, PhD, Anne-Marie Gevers, MD, Paul Rutgee...

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Self-expandable metallic stents in the palliation of rectosigmoidal carcinoma: a follow-up study Jan Tack, MD, PhD, Anne-Marie Gevers, MD, Paul Rutgeerts, MD, PhD Leuven, Belgium

Background: Currently applied endoscopic palliative treatment of advanced rectosigmoidal carcinoma is hampered by the cost of the equipment, the need for repeated, often painful treatment sessions, and the occurrence of complications. Metallic expandable stents are effective in the palliation of malignant esophageal and biliary stenoses. We evaluated the use of a new type of self-expandable nitinol stent in the palliation of rectosigmoidal carcinoma. Methods: In 10 patients with advanced obstructing rectosigmoidal carcinoma, initial Nd:YAG laser treatment was performed if necessary to allow passage of a gastroscope. Subsequently, a self-expanding nitinol stent with flanged ends was inserted under combined fluoroscopic and endoscopic control. Endoscopic and clinical follow-up was carried out at regular intervals. Results: After 2 ± 0.4 sessions of initial laser therapy, minimal lumen diameter was 9 ± 1 mm. Stent insertion was successful in 9 patients, increasing minimal lumen diameter to 14 ± 1.2 mm (p < 0.005). In one patient, stent deployment was complicated by a sigmoid perforation, requiring surgery. After insertion, colorectal stents remained adequately positioned and free of obstruction for 103 ± 31 days. Patient survival after stent placement was 204 ± 43 days. Stent migration occurred in 3 patients, after 38 ± 10 days. Obstruction of the stent because of tumor ingrowth was observed in only one patient, after 268 days. Conclusion: Insertion of self-expandable nitinol stents in patients with rectosigmoidal carcinoma is technically feasible. Metallic stents are effective in the palliation of malignant rectosigmoid obstruction; they provide an alternative to repeated palliative laser therapy or palliative surgery. (Gastrointest Endosc 1998;48:267-1.)

For patients with malignant rectosigmoidal strictures, several endoscopic approaches have been advocated as an alternative to palliative surgery. These include endoscopic balloon or Savary dilation, Nd:YAG laser therapy, electrocoagulation, injection of polidocanol, photodynamic therapy, and cryotherapy.1-9 However, most of these therapies are hampered by the cost of the equipment, the need for Received August 12, 1997. For revision January 13, 1998. Accepted April 30, 1998. From the Department of Internal Medicine, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium. Reprint requests: J. Tack, MD, PhD, Department of Internal Medicine, Division of Gastroenterology, University Hospital Gasthuisberg, Herestraat 49, Leuven, Belgium. Copyright © 1998 by the American Society for Gastrointestinal Endoscopy 0016-5107/98/$5.00 + 0 37/1/91386 VOLUME 48, NO. 3, 1998

repeated, often painful treatment sessions, and the occurrence of complications. Metallic stents are effective in the endoscopic palliation of malignant esophageal and biliary stenoses.10-12 Recently, successful short-term palliation of malignant rectal strictures using self-expanding metallic stents has been reported by several groups of investigators.13-25 However, most of these studies reported only short-term experience in limited numbers of patients. We evaluated the long-term usefulness of a new type of metallic stent in the palliation of rectosigmoidal carcinoma. PATIENTS AND METHODS Ten patients with advanced obstructing rectosigmoidal carcinoma were referred for palliative therapy; 6 were men, 4 were women, and their mean age was 74 ± 2.9 years. All patients had metastatic rectal or sigmoidal adeGASTROINTESTINAL ENDOSCOPY

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Self-expandable stents and rectosigmoidal carcinoma

Figure 1. Expanded rectosigmoidal nitinol stent.

Figure 2. Radiographic sequence showing an obstructing rectosigmoidal cancer. A, Before stent insertion. B, After stent insertion. As shown in B, external radiopaque markers spaced 1 cm apart serve as a reference to measure stenosis dimensions before and after stent insertion. nocarcinoma, confirmed by endoscopic, pathologic, and radiologic studies. Two patients had local and metastatic tumor recurrence after previous surgery for sigmoid adenocarcinoma. All patients had symptoms of rectosigmoidal obstruction, including abdominal distension with pain, tenesmus, small-caliber stools, and constipation. Patient characteristics are summarized in Table 1. Seven patients had previously been treated by Nd:YAG laser therapy (9 ± 2.4 sessions). All patients gave informed consent. The protocol had been approved by the ethical committee of our hospital. The stent used consists of uncoated meshes of nitinol wire (Boston Scientific, Natick, Mass.). The wire strands are twisted together to construct a diamond configuration and are welded at the ends. The stents have lengths of 4, 6, 8, or 10 cm, and a 2 cm flare at each funnel-shaped end (Fig. 1). By design, the stent resists radial compression and easily conforms to bends in the colorectal anatomy without collapsing. The stents are compressed onto a single tapered flexible wire-guided delivery catheter. The delivery catheter is tapered from 16F in the distal region to 10F in the proximal region where the stent is mounted. 268

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The catheter has a bulbous tapered tip at the distal end and a round hub handle at the proximal end. The stent is held onto the delivery catheter by a crocheted nylon suture wrapped around the stent. The free end of the suture passes through the handle and is affixed to a finger ring on the end of the handle hub. Two radiopaque marker bands on the delivery catheter indicate the expected final position of the deployed stent at its distal and proximal ends. The stent can be deployed by retracting the finger ring, thereby releasing the suture crochet knots in a circular manner down the length of the stent. After deployment, the stents expand to a maximal internal diameter of 20 mm along the shaft and 35 mm at the funnel-shaped ends, shortening in length by about 20%. If necessary, initial Nd:YAG laser treatment was performed to allow passage of a gastroscope. Radiologic and endoscopic assessments of the dimensions of the stenosis were carried out 1 to 3 days before stent insertion. Subsequently, stent insertion was carried out under combined fluoroscopic and endoscopic control. No intraluminal contrast was used during stent insertion. A gastroscope was used to place a guidewire across the stricture. VOLUME 48, NO. 3, 1998

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Figure 4. Endoscopic image of an expanded rectosigmoidal stent in position. Figure 3. Abdominal radiograph demonstrating the expanded nitinol funnel-shaped stent in position.

The gastroscope was then removed, and the delivery catheter was advanced over the guidewire. Radiopaque markers on the delivery catheter were used to aid stent positioning under fluoroscopic control. The gastroscope was introduced again to visualize the distal end of the malignant stricture. The stent was deployed by retracting the restraining sheath under fluoroscopic monitoring, while the distal position was checked endoscopically. No attempt was made to insert the gastroscope into the stent immediately after stent insertion. Radiologic and endoscopic assessment of the dimensions of the stenosis were repeated 3 to 5 days after stent insertion. Balloon dilatation of the stent was performed in case of insufficient spontaneous deployment. Endoscopic and clinical follow-up was carried out at regular intervals (every 1 to 3 months). Repeat abdominal radiographs or contrast studies were only obtained as clinically indicated. All data are expressed as mean ± SEM.

RESULTS Initial laser therapy, required to allow passage of a gastroscope, was carried out before stent insertion in 6 patients (2 ± 0.4 sessions). Four of these patients had previously undergone palliative YAG laser therapy. Radiologic assessment 1 to 3 days before stent insertion showed a malignant stenosis with a length of 51 ± 4 mm and a minimum diameter of 9 ± 1 mm. Stent insertion was successfully achieved with one stent in 9 patients (90%). There were no deaths associated with stent implantation. In one patient, stent deployment was complicated by an acute sigmoid perforation, requiring a surgical colostomy. Before stent insertion, this patient received 3 endoscopic laser sessions, one of which VOLUME 48, NO. 3, 1998

Figure 5. Life-table plot of stent survival (adequately positioned and free of obstruction) and patient survival after positioning of self-expandable metallic stents for palliation of malignant rectosigmoidal obstruction.

was complicated by the creation of a blind extraluminal pocket. It seems likely that this facilitated the subsequent perforation during stent insertion. No other early complications were observed. After stent deployment, the minimal lumen diameter was 14 ± 1.2 mm (p < 0.005 compared with prestent) (Figs. 2 to 4). In most patients, the stent did not deploy to its full 20 mm diameter at the shaft, but this did not restrict passage of barium or an endoscope. None of the patients required balloon dilatation because of insufficient stent expansion. In one patient, elective surgical colostomy was carried out 3 weeks after stent deployment because of persisting tenesmus. In the 8 other patients, the stent GASTROINTESTINAL ENDOSCOPY

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Table 1. Long-term results of self-expandable metallic stents in the palliation of rectosigmoidal carcinoma Patient

Sex

Age

Tumor location

1 2 3 4 5 6 7 8 9 10

M M F F M F F M M M

85 72 80 85 68 73 61 66 64 84

Rectum Rectum Rectum Rectum Rectum Rectum Rectum Rectum Sigmoid Rectum

provided good palliation, with normal passage of stools and absence of complaints due to the stent. Patients were followed for 204 ± 43 days (Table 1). After insertion, colorectal stents remained adequately positioned and free of obstruction for 103 ± 31 days (Fig. 5). Distal stent migration, with anal expulsion of the stent, occurred in 3 patients, after 38 ± 10 days. In none of these patients was stent migration followed by early obstruction. Two of these three patients required no further therapy for obstruction until death; in the third patient elective surgical colostomy was carried out 4 weeks later. Obstruction of the stent because of tumor ingrowth was observed in only one patient after 268 days. This was successfully relieved by a single laser session. Mean survival after stent placement was 204 ± 43 days (Fig. 5). Five patients died with a stent still in position, 180 ± 38 days after stent insertion. All patients died because of progression of the initial disease; none of the five patients with stents in position at death had clinical or radiologic signs of stent obstruction at the time of death. DISCUSSION Since the original description of the clinical use of self-expanding metal stents for vascular stenoses,26 they have been successfully applied in the management of esophageal and biliary malignant stenoses.10-12 Recently, successful short-term palliation of malignant rectal strictures using selfexpanding metallic stents has been reported by several groups of investigators.13-25 However, most of these studies report only short-term experience in limited numbers of patients. Four studies describe the use of stent insertion for preoperative decompression in patients with acute obstruction secondary to colorectal neoplasm to avoid two-stage surgery.16,20,21,24 All studies reported rapid resolution of the colonic obstruction in all patients (respectively 2, 12, 25, and 13 270

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Stent evolution Uncomplicated Elective surgery after 22 days Migration after 5 days Tumor ingrowth after 268 days Uncomplicated Migration after 71 days Uncomplicated Uncomplicated Migration after 41 days Acute perforation

Patient survival (days) 106 294 516 273 225 164 77 217 72 93

patients), with a relatively low rate of failure (4 patients with unsuccessful stent placement or early stent migration) or complications (2 perforations, 2 early stent obstructions). Subsequent single-stage surgery was carried out in the majority of the patients. In 13 patients with disseminated disease, stent placement was considered the primary palliative treatment, but long-term follow-up data are lacking. Other reports address the use of self-expandable metallic stents in the palliative treatment of obstructing rectosigmoidal adenocarcinoma. Spinelli et al.13,14 reported the use of a self-expanding stainless steel mesh stent in the palliation of 13 patients with colorectal obstructing tumors. Insertion under endoscopic control was successful in 12 patients, with luminal patency being maintained in 10 patients after a mean follow-up of 7 months. Two stent-related complications (tumor ingrowth after 1 month and rectal perforation after 3 months) were observed. Rey et al.18 reported successful palliation of rectal tumors using laser therapy, followed by the insertion of a flexible self-expanding stainless steel stent. Stenting, which was successful in 11 of 12 patients, seemed to allow a decrease in the number of laser sessions required to maintain luminal patency. Stent migration occurred in three patients and was treated by successful insertion of a second stent. In addition to these studies, a number of case reports involving the use of expandable metal stents in the treatment of malignant colorectal stenoses have been published.15,17,19-25 In the present study, we used funnel-shaped nitinol stents in the palliative treatment of 10 patients with advanced rectosigmoidal adenocarcinoma. Deployment was successful in 9 patients, and there was one acute complication (perforation requiring immediate colostomy). The perforation may have been facilitated by the creation of a blind extraluminal pocket during laser therapy before the stent insertion. It is unclear whether the final event trigVOLUME 48, NO. 3, 1998

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gering the perforation was the endoscopic manipulation before stent deployment , the stent introducer, or the expansion of the stent. During a follow-up of 204 ± 43 days, we observed that endoscopic colorectal stent placement provides satisfactory long-term palliation. One patient preferred to have elective surgery early after stent placement. Stent migration occurred in three patients. In these patients, the location or the diameter of the stenosis did not differ appreciably from those in patients without stent migration. Distal stent migration may have been facilitated by adequate recanalization of the malignant stricture, as it was never followed by early obstruction. For that reason, no attempt at insertion of a second stent was made. Recurrent obstruction due to tumor ingrowth developed in only one patient, 263 days after stent insertion, and it was relieved by a single laser treatment session. Our experience demonstrates that insertion of nitinol stents in patients with rectosigmoidal carcinoma is technically feasible and that it is useful in the palliation of malignant colorectal obstructions. Although acute complications may occur, the frequency at which untoward events occur may actually be comparable with that of other endoscopic palliative procedures.1-12,22 Therefore self-expandable metallic stents may provide an alternative to laser therapy or surgery in the palliation of malignant rectosigmoidal stenosis. A prospective trial comparing these other forms of treatment with metal expandable stent insertion seems warranted. REFERENCES 1. De Lange EE, Shaffer HA Jr. Rectal strictures: treatment with fluoroscopically guided balloon dilation. Radiology 1991;178:475-9. 2. Banerjee AK, Walters TK, Wilkins R, Burke M. Wire-guided balloon coloplasty—a new treatment for colorectal strictures. J R Soc Med 1991;84:136-9. 3. Virgilio C, Cosentino S, Favara C, Russo V, Russo A. Endoscopic treatment of postoperative colonic strictures using an achalasia dilator: short-term and long-term results. Endoscopy 1995;27:219-22. 4. Spinelli P, Dal Fante M, Meroin E. Endoscopic laser therapy of colorectal tumors. Acta Endosc 1987;17:157-68. 5. Nagy AG. Palliative treatment of advanced colorectal carcinoma with the Yag laser. Can J Surg 1990;33:261-4. 6. Hoekstra HJ, Verschueren RCJ, Oldhoff J, van der Ploeg E. Palliative and curative electrocoagulation for rectal cancer: experience and results. Cancer 1985;55:210-3. 7. Marini E, Frigo F, Cavarzere L, Cutolo S, Palazzin L, Orcalli F. Palliative treatment of carcinoma of the rectum by endoscopic injection of polidocanol. Endoscopy 1990;22:171-3.

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